COVID-19 infections - Remote Early Detection | COVID-RED | Project | Results | H2020 | CORDIS

Report describing an initial dissemination, communication and exploitation plan

TASK 61 Develop dissemination and exploitation plan M1M18 UMCU AvaTask 61 will develop and implement a strategic dissemination strategy WP lead and coleads will review the strategy regularly to ensure effective implementation The dissemination strategy will outline specific tools such as conferences and congresses scientific publications social media and newsletters to ensure COVIDRED progress and outcomes have impact beyond the scope of defined project activities In order to align all parties on dissemination standards and present a strong external facing image dissemination activities will first focus on project presentation after which the focus will shift to publishing progress and community buildingI Presenting the project M1M4 ie preparing different societal actors for COVIDRED and attracting their interest Actions 1 generation of a strong visual COVIDRED identity logo manual templates 2 development of a public website to serve as the projects showcase and main repository for communication materials including a web domain 3 generation of an initial communication pack animation and poster infographics to present the project to a broad audience 4 setting up social media accounts according to ECs guidance note on social media 042018 and launch an initial promotional campaign 5 creation of communication materials to present COVIDRED at specialized events and to foster exploitation and dissemination actions 6 development of an advanced communication analysis including a comprehensive study of issues affecting the communication activities with a particular emphasis on the context challenges and opportunities for the communication of benefits and challenges related to remote monitoring of COVID19 and other possible pandemics at a European and global levelII Publish project progress and build a community M4M18 ie promoting the project reporting its progression main milestones and project related topics Actions 1 development of a social media strategy with regular and original content creation and monthly metrics analysis 2 regular updates in the project blog progress updates partner presentations news 3 publication strategy press dossier and releases graphical and audiovisual content writing of articles and eNewsletters 4 development of audiovisual materials covering projectrelated topics 5 appointment of an COVIDRED Ambassador to represent the consortium in educational and outreach activities The communication strategy outlined above will be regularly monitored reviewed and updated to maximize the impact among all the stakeholders in this way setting the basis for successful uptake and implementation of COVIDRED results and methodologies

Report on sustainability model for data storage

Task 54 Implement a longterm sustainable model for data storage meeting FAIR requirements M3M18 UCL AvaThe short and longterm value of the data collected from this study is hard to overstate The combination of semicontinuous vital signs data patientreported signs and symptoms in a longitudinal fashion and intermediate and final COVID status being determined and collected for all patients is unique in the current environment of COVID studies To that end this consortium emphasizes the need to make the study data broadly available to further legitimate research requests The data collected for this study will be structured to meet FAIR requirements This will include structuring data capture with consideration to COVID19 guidance where applicable The platform for research will initially be funded by the budget for this proposal but this will be transitioned towards a sustainable model This work package will work closely with the consortium partners in order to establish appropriate policies and procedures for making each data source FAIR with a specific focus on enabling renewal of agreements at the time of any change in control such as when the funding from the EU commission ends and the project moves into a longterm sustainable framework

Study subject approvals package

TASK 33 Execution of the study M8M17 UMCU Ava Julius Clinical The partners of the consortium have extensive experience in the setup site selection recruitment and the monitoring of large multicountry studies for both academic and pharma industry purposes with study results used in the context of regulatory decisionmaking JCR will manage and monitor the study and its progress making sure timelines are being met and performing quality and data monitoring to assure the delivery of data of a quality fit for purpose A higher level of support is expected to be required than in traditional studies to address concerns specifically related to the remote monitoring approach

Report with stakeholder landscape analysis

TASK 62 Understand stakeholder needs and perceptions and align with project outcomes M1M24 UMCU AVA RocheThe aim of task 62 is to engage in a series of activities involving stakeholders to identify barriers and enablers of remote monitoring devices and apps for detecting early signs of COVID19 infections In this task UMCU WPL 6 will use the HINL Round Table Service to gather insights from key stakeholders regulatory public health and governmental bodies epidemiologists healthcare workers research organisations etc on their needs and perceptions to help achieve project goals and deliver maximum possible value and impact to target audiences The HINL Round Table is designed to give innovators early insights into the path to market and the needs of all stakeholders along the way Stakeholder experts will include for example patients medical specialists insurers health authorities regulators hospital board representatives CE experts and health technology assessment HTA specialists A written Innovation Guide that summarizes the outcomes of the desk research and the Round Table discussion It provides a single comprehensive document that outlines the collective recommendations of your critical stakeholders including clear next steps to guide further development COVIDRED resultsThis task will help the WPs to design outputs that align to stakeholder needs Any needs identified that are beyond the scope of project will be curated and communicated to other funding bodies as possible future call topics

Project management plans

Task 71 Scientific coordination and progress management M1 M18 UMCU all Task 71 will involve 1 preparation of annual implementation plans 2 overall scientific coordination of research activities and monitoring of progress within WPs to ensure fulfilment of all project aims objectives and deliverables 3 supporting WP leaders integrating partners within their WP as well as ensuring smooth transfer of results between WPs 4 guidance of consortium compliance with ethics and research integrity requirements 5 installation of a Managing Board MB responsible for scientific review of WP reports scientific quality progress and results risk assessmentmanagement as well as fulfilment of deliverables and milestones 6 installation of an external Advisory Board AB that will be provided with a charter for its tasks and responsibilities invited to the kickoff and quarterly meetings and be asked to provide a review report to the MB in order to discuss and give feedback on the scientific progress and problems that may arise during the COVIDRED 7 handling of any kind of fraud unethical behavior and breach of procedures and together with the coordinator and General Assembly GAM propose corrective actions to the MB

Detailed project plans plus tracking tools, to be maintained throughout the life of the project

Task 71 Scientific coordination and progress management M1 M18 UMCU all Task 71 will involve 1 preparation of annual implementation plans 2 overall scientific coordination of research activities and monitoring of progress within WPs to ensure fulfilment of all project aims objectives and deliverables 3 supporting WP leaders integrating partners within their WP as well as ensuring smooth transfer of results between WPs 4 guidance of consortium compliance with ethics and research integrity requirements 5 installation of a Managing Board MB responsible for scientific review of WP reports scientific quality progress and results risk assessmentmanagement as well as fulfilment of deliverables and milestones 6 installation of an external Advisory Board AB that will be provided with a charter for its tasks and responsibilities invited to the kickoff and quarterly meetings and be asked to provide a review report to the MB in order to discuss and give feedback on the scientific progress and problems that may arise during the COVIDRED 7 handling of any kind of fraud unethical behavior and breach of procedures and together with the coordinator and General Assembly GAM propose corrective actions to the MB

Tendering procedure description

TASK 73 Financial and periodic reporting M1M24 UMCUTask 73 will involve overall budget management including calculation and monitoring of individual partner budgets and cost justification keeping central records of financial management and coordination of timely submission of required financial reports by all beneficiaries As WP7 leader UMCU will manage control of money transfers within the consortium informing partners and IMIEC about financial transfers and will provide guidance to partners on financial rules and requirements

Definition of the areas of collaboration

TASK 76 Support collaboration activities and potential synergies with grants awarded under the Call IMI220202101 M1 M18 UMCUWith the current investment in COVIDrelated research it is of critical importance that information exchange and crossproject learning is optimized in order to assure synergies and avoid duplication of efforts In this task we will collaborate with the other projects that were awarded as part of Call IMI220202101 in there area of therapeutics and diagnostics Envisioned areas for collaboration are data sharing communication and dissemination stakeholder engagement and discussing practical implications of project outputs The collaboration activities will be reported during project reporting

Report on small feasibility study & proposed adaptations to the protocol to be made

TASK 32 Feasibility study M1M2 UMCU Ava Julius Clinical An initial dry run small feasibility study of the trial protocols technology recruitment strategy and processes will be performed utilising site andor internal consortia resources on a limited number of subjects 310 as appropriate The exact profile of the resource andor number of subjects will depend on the technology and processes to be tested The dry run feasibility will test the specific technologies and processes to check the quality and veracity of the data generated by the approach determine whether there are any unanticipated operational issues and get feedback from the subjects and their healthcare providers on ways to improve the conduct of the study Based on these findings the study setup will be optimised and finalised

Report on relevant regulatory requirements

TASK 63 Develop and execute regulatory plan M6 M24 Julius Clinical UMCUTask 63 aims to produce guidance for the consortium and external stakeholders on roles and responsibilities of different regulatory agencies at European and national levels and their decisionmaking pathways when assessing remote monitoring systems for use in epidemiologic monitoring and other relevant fields This task will 1 ensure all partners understand the qualification and decisionmaking pathways of regulatory authorities 2 plan potential engagement with regulatory authorities to facilitate adoption of new methods for remote monitoring of infectious disease in collaboration with WP14 and 3 develop a checklist of best practices for settingup remote monitoring technologies as new strategies for current and future epidemics as well as to help more efficiently allocate scarce resources for monitoring diagnosis and early treatment This task will be based on the results of task 62

Report on the interventions costs/price of the Ava monitoring device

TASK 41 Determining the intervention costs M1M4 VIVE UMCUTask 41 involves determining the intervention costs of the AVA monitoring device Interventions costs comprise the costs of implementing and operating the system MethodsDuring the cohort study we will collect cost data related to the AVA monitoring device In estimating costs we follow the lines of Drummond et al 2015 37 and the Dutch Guideline for economic evaluation in healthcare 38 Estimating costs in a health economic evaluation consists of three steps First we identify all relevant additional costs associated with the intervention and identify whether there are cost savings relative to standard treatment This is done in close collaboration with the team running the intervention Secondly we measure the resource use in the natural unit This means that the costs of the intervention will be measured as AVA devices purchased programmer hours spent doctor hours spent etc Data will as far as possible be collected from administrative data as well as accounting data from within the project Finally when all the relevant cost components are identified and measured using their natural unit each cost component is valued using the appropriate unit pricesThis rigorous approach to cost estimation provides full transparency of the individual cost component and makes international comparison easier as unit costs might differ substantially between countries The costs will be divided into fixed and variable costs to access the expected costs per patient when implementing the AVA monitoring device to the very large scale The costs will be calculated for the technological equipment as well as the costs associated with health care professionals as these two cost components might differ substantially in an international context

Report on final analysis of results

TASK 35 Clinical Analysis of study results and future recommendations M4M12 UMCU Julius Clinical AVA RocheThere are multiple research questions included within this project Appropriate statistical methods will be selected for each question depending upon the nature of the data distribution as well as the effect that is to be characterised Cohort 3 provides a reference group towards Cohorts 1 and 2 for Device Signs and symptoms diary vs Signs and symptoms diary alone comparisons Cohorts 1 and 2 also allow for withinsubject comparisons of the machine learning models with and without the inclusion of the Device data into the models Comparisons against Cohort 3 allow for the actual impact of recommendations coming from Device Signs and symptoms diary vs Signs and symptoms diary alone Comparisons against Cohort 3 also allow for the assessment of the Device impact on compliance to the signs and symptoms diary data entry Comparisons within Cohorts 1 and 2 allow for assessing the impact of the Device on the predictiveness of the machine learning with all other things being equal The study will contain two epochs as relates to the machinelearning approach for the recommendation algorithms The first epoch is the learning phase during which the ML models will be developed ML models for Cohorts 1 and 2 can consider baseline data signs and symptoms diary data and Device data ML models for Cohort 3 can consider baseline data and signs and symptoms diary data but do not have Device data The second epoch is the confirming phase during which the operational characteristics of the recommendation algorithms will be formally assessed During the confirming phase it is expected that all subjects will be provided realtime recommendations The algorithm may continue to adapt during this epoch but realtime recommendations should not be turned off during this period unless is it is determined to be ineffective and the study discontinued During the learning phase there may be periods during which the subjects provide data but the signs and symptoms diary does not yet indicate a recommendation The recommendation feature could be turned on and off multiple times during the learning period The status of this functionality will be clearly indicated to the subjects at all timesThe performance of the recommendation algorithm during the confirming phase of the study will be assessed using sensitivity specificity and AUC The serology status from end of followup for each subject still alive at that time will be used as the gold standard For subjects not alive at end of followup the status of available viral load data will be used positive at any time and for those without viral load data physician diagnosis will be accepted provided there was a supportive lung CT scan used All other subjects will be summarized for transparency but excluded from the estimation for sensitivity specificity and AUC The sensitivity specificity and AUC will be presented once a sufficient number of subjects have reached end of followup as well as for each month prior using the end of followup status to assess the evolution of the recommendation algorithm over time These statistics will be provided within Cohort 1 with and without Device data Cohort 2 with and without Device data and Cohort 3 for comparative purposes The withinsubject comparisons within Cohort 1 and Cohort 2 will be used to assess the added predictive value of the Device The differences between Cohort 1Cohort 2 vs Cohort 3 will be used to assess the impact on realtime recommendations whether to visit their healthcare provider and the impact of the Device on signs and symptoms diary compliance The calculation of differences will reweight the subjects so that Cohort 1Cohort 2 has a similar risk profile as Cohort 3Additional statistical metrics will be provided to support assessment of the clinical outcomes

Report describing a final dissemination, communication and exploitation plan

TASK 61 Develop dissemination and exploitation plan M1M18 UMCU AvaTask 61 will develop and implement a strategic dissemination strategy WP lead and coleads will review the strategy regularly to ensure effective implementation The dissemination strategy will outline specific tools such as conferences and congresses scientific publications social media and newsletters to ensure COVIDRED progress and outcomes have impact beyond the scope of defined project activities In order to align all parties on dissemination standards and present a strong external facing image dissemination activities will first focus on project presentation after which the focus will shift to publishing progress and community buildingI Presenting the project M1M4 ie preparing different societal actors for COVIDRED and attracting their interest Actions 1 generation of a strong visual COVIDRED identity logo manual templates 2 development of a public website to serve as the projects showcase and main repository for communication materials including a web domain 3 generation of an initial communication pack animation and poster infographics to present the project to a broad audience 4 setting up social media accounts according to ECs guidance note on social media 042018 and launch an initial promotional campaign 5 creation of communication materials to present COVIDRED at specialized events and to foster exploitation and dissemination actions 6 development of an advanced communication analysis including a comprehensive study of issues affecting the communication activities with a particular emphasis on the context challenges and opportunities for the communication of benefits and challenges related to remote monitoring of COVID19 and other possible pandemics at a European and global levelII Publish project progress and build a community M4M18 ie promoting the project reporting its progression main milestones and project related topics Actions 1 development of a social media strategy with regular and original content creation and monthly metrics analysis 2 regular updates in the project blog progress updates partner presentations news 3 publication strategy press dossier and releases graphical and audiovisual content writing of articles and eNewsletters 4 development of audiovisual materials covering projectrelated topics 5 appointment of an COVIDRED Ambassador to represent the consortium in educational and outreach activities The communication strategy outlined above will be regularly monitored reviewed and updated to maximize the impact among all the stakeholders in this way setting the basis for successful uptake and implementation of COVIDRED results and methodologies

Report on the outcomes and associated hospital costs

TASK 42 Assessing the economic outcomes M5M8 VIVETask 42 aims to assess the outcomes of operating the monitoring device and detection of early signs of COVID19 Outcomes considered include cost of testing physician visitslength of stay for patients admitted to the hospitalICU transfers etc Methods The methods applied in Task 42 will follow the same rigorous approach to cost estimation as in Task 41 This means that after identifying a complete list of relevant outcomes individual data related to health care contacts will be collected from administrative hospital data For the final valuation of the treatment patient data will be linked to costs data from the hospital

Interim report on testing results for SARS-CoV-2 virus

TASK 22 Testing study participants for SARSCoV2 virus M1M18 Roche Risch Risch servicesDuring the cohort study positive signals that are generated by the algorithm developed in WP1 will be followed up by molecular SARSCoV2 testing In the Netherlands anyone with respiratory symptoms can be tested freeofcharge for the SARSCoV2 virus as of 1 June 2020 The government aims to provide a test result within 24 hours and anyone who tests positive is automatically transferred to the public contacttracing programme We will therefore evaluate the possibility of asking study participants with a positive signal to attend the nearest public testing site and to share the testing information with the study team Some participants may not have access to public testing for example because they do not have overt symptoms and these participants will be tested by the study team In the Principality of Liechtenstein people with symptoms of COVID19 are recommended to be tested by a COVID19 RTPCR assay This test is covered by mandatory health insurance In addition individuals without symptoms wanting to be tested can also get an RTPCR test on their own cost The Liechtenstein RTPCR testing is done in a central lab labormedizinisches zentrum Dr Risch which is accredited according to ISO 17025 The laboratory is officially recognized by the Liechtenstein and Swiss office of Public Health for testing of SARSCoV2 virus and represents one of the Swiss testing labs accomplishing the highest test volumes Study participants are asked to get tested as soon as they have symptoms compatible with COVID19 For this purpose they can consult the national drivethrough testing site their family physician or the emergency room of the national hospital Should participants use testing abroad they will be asked to provide the result Alternatively the study team contacts the national office of Public Health which knows all the cases of notifiable diseases including COVID19 The COVIGAPP study is run by the study team of the national laboratory running almost all COVID19 tests in the country RTPCR testing for SARSCoV2 is done using the Roche cobas SARSCoV2 Test designed for use on the cobas 6800 or cobas 8800 instruments These instruments are available at the central laboratory of the Dutch blood bank Sanquin and other locations including the labormedizinisches zentrum Dr Risch in Buchs Switzerland The test is a singlewell dual target assay which includes both specific detection of SARSCoV2 and of the sarbecovirus subgenus family that includes SARSCoV2 Roche has committed 60008000 SARSCoV2 tests to this study This capacity may not be needed given the fact that we will possibly refer most participants to public testing sites in which case we will test a subset of participants for additional respiratory pathogens such as influenza and RSV The signs and symptoms caused by these pathogens are similar to those caused by COVID19 and this additional testing will improve our ability to determine the WP1 algorithms specificity The participants selected for this substudy will attend a public testing site but in addition they will selfcollect a nasopharyngeal swab at home and store it in a freezer until transport to the laboratory If possible samples could be analysed for several respiratory pathogens using the Roche platform

A first draft of a scientific paper reporting on the results of the cost-consequence analysis for publication in an international peer-review journal

TASK 43 Costconsequence analysis M13M18 VIVETask 43 is a costconsequence analysis In the analysis the net costs of the system will be measured against the benefits in terms of more effective use of the hospital system and improved health outcomesMethods The costconsequence analysis will be based on the data collected in previous tasks A sensitivity analysis will be performed to access the robustness of the estimated costs and effects to ensure a nuanced representation of the evidence The sensitivity analysis shows how sensitive the results are to changes in some of the key driving parameters of the costs and effects respectively This is done by recalculation the results based on probable values from the distribution of the key parameters

Study protocol

TASK 31 Protocol development M1M3 Julius Clinical Ava UMCU Roche Within this task the protocol for the cohort study will be developed The study will be a prospective observational study in a set of three clearlydefined cohorts that follows the course of the disease exposure development of disease symptoms and disease outcomes during the initial and following waves of the COVID epidemic in order to answer the research questions introduced above Cohort recruitment will be staggered over multiple waves through the course of the study The three cohorts will be recruited contemporaneously within each wave The study will have the following characteristicsSize and composition of the three cohortsDevice plus signs and symptoms diary 20koCohort 1 13k sample from general populationoCohort 2 7k highrisk sample highrisk individuals due to agecomorbidities or profession Signs and symptoms diary comparator 20koCohort 3 20k sampled from general and highrisk population Study populationlocation The Netherlands current users of an existing PROssymptoms app created by the OLVG hospital in AmsterdamAdults 18 years and over with enrichment for highrisk personsOutcome measuresCollection of SARSCoV2 infection status negative or positive via PCR for participants who are referred or for participants who otherwise obtain such resultsConfirmation of SARSCoV2 status via serology for all participants at the end of followupHealthcare utilisation incl treatments usedClinical prognosis at the time of diagnosed SARSCoV2 and survival statusTime to testVariablesDiary collection of signs and symptoms on a routine basisNighttime average skin temperature heart rate and breathing rate Cohorts 1 and 2 collected each day of study participationBaseline demographics and comorbiditiesBaseline medicationsBaseline finger prick samples to enable full or partial assessment of SARSCoV2 status via serologyChanges in comorbidities andor medicationsDuration of use for device users Participants will be followed for an initial period of at least 34 months with an option to extend participation A staggered enrolment approach will be used to ensure continuous observation over the course of the duration of the study Recruitment for the three cohorts will take place via OLVG andor Luscii who will contact the current users of the Corona Check App on behalf of COVIDRED No userlevel data will be needed by COVIDRED to subselect the research participants who will be contacted In case this recruitment procedure does not deliver as per protocol and study plan a social media campaign will be set up More details on the procedures and criteria that will be used to identifyrecruit research participants will be provided prior to the start of the research activity as part of the study protocol D31 Since COVIGAPP is already underway as a separate study there are no COVIGAPP recruitment or identification elements that are supported within COVIDRED This project will include participants at higher risk of COVID19 infection due to health or demographic status or due to their employment We do not consider the device to directly impact their risks Theoretically the device could indirectly impact COVID19 risks or outcomes based on changes in participant behaviours This will be addressed in the informed consent training materials video and participants will be in direct contact with triage support in those cases where there is a suspicion of COVID19 infection This is the same triage team which assesses Dutch nationals today and recommends GP or hospital followup Patient privacy is an important feature of this study and health data will not be accessible to the public Identifiable data will be collected with consent and limited to those systems where necessary Where not necessary only a uniqueuser ID will be use

Report on lessons learned to inform checklist creation

TASK 36 Develop advice for further use of tested approach M4M12 UMCUTask 36 will be closely aligned with Task 63 and will combine lessons learned from the cohort study with stakeholder analysis and recommendations Task 62 and regulatory requirements Task 63 in order to create a checklist for setting up remote monitoring technologies for infectious diseases

Midterm recruitment report

TASK 34 Monitor the cohort study for operational quality M4M12 Julius ClinicalThe conduct of the cohort study will be closely monitored for scientific and operational quality Quantitative and qualitative information will be obtained to judge the scientific and operational quality as well as the costs and efficiency of the approach Based on these findings improvements may be suggested according to which adaptations and optimisations may be considered during the running phase At the time point when 50 of the study population is expected to have been recruited a midterm recruitment report will be submitted to IMI JU The report will include an overview of recruited subjects by study site potential recruiting problems and if applicable a detailed description of implemented and planned measures to compensate delays in the study subject recruitment

Report on the barriers and enablers of remote monitoring devices and apps for detecting early signs of COVID-19 infection

TASK 62 Understand stakeholder needs and perceptions and align with project outcomes M1M24 UMCU AVA RocheThe aim of task 62 is to engage in a series of activities involving stakeholders to identify barriers and enablers of remote monitoring devices and apps for detecting early signs of COVID19 infections In this task UMCU WPL 6 will use the HINL Round Table Service to gather insights from key stakeholders regulatory public health and governmental bodies epidemiologists healthcare workers research organisations etc on their needs and perceptions to help achieve project goals and deliver maximum possible value and impact to target audiences The HINL Round Table is designed to give innovators early insights into the path to market and the needs of all stakeholders along the way Stakeholder experts will include for example patients medical specialists insurers health authorities regulators hospital board representatives CE experts and health technology assessment HTA specialists A written Innovation Guide that summarizes the outcomes of the desk research and the Round Table discussion It provides a single comprehensive document that outlines the collective recommendations of your critical stakeholders including clear next steps to guide further development COVIDRED resultsThis task will help the WPs to design outputs that align to stakeholder needs Any needs identified that are beyond the scope of project will be curated and communicated to other funding bodies as possible future call topics

Third report from the advisory board

Task 71 Scientific coordination and progress management M1 M18 UMCU all Task 71 will involve 1 preparation of annual implementation plans 2 overall scientific coordination of research activities and monitoring of progress within WPs to ensure fulfilment of all project aims objectives and deliverables 3 supporting WP leaders integrating partners within their WP as well as ensuring smooth transfer of results between WPs 4 guidance of consortium compliance with ethics and research integrity requirements 5 installation of a Managing Board MB responsible for scientific review of WP reports scientific quality progress and results risk assessmentmanagement as well as fulfilment of deliverables and milestones 6 installation of an external Advisory Board AB that will be provided with a charter for its tasks and responsibilities invited to the kickoff and quarterly meetings and be asked to provide a review report to the MB in order to discuss and give feedback on the scientific progress and problems that may arise during the COVIDRED 7 handling of any kind of fraud unethical behavior and breach of procedures and together with the coordinator and General Assembly GA propose corrective actions to the MB

Second report from the advisory board

Task 71 Scientific coordination and progress management M1 M18 UMCU all Task 71 will involve 1 preparation of annual implementation plans 2 overall scientific coordination of research activities and monitoring of progress within WPs to ensure fulfilment of all project aims objectives and deliverables 3 supporting WP leaders integrating partners within their WP as well as ensuring smooth transfer of results between WPs 4 guidance of consortium compliance with ethics and research integrity requirements 5 installation of a Managing Board MB responsible for scientific review of WP reports scientific quality progress and results risk assessmentmanagement as well as fulfilment of deliverables and milestones 6 installation of an external Advisory Board AB that will be provided with a charter for its tasks and responsibilities invited to the kickoff and quarterly meetings and be asked to provide a review report to the MB in order to discuss and give feedback on the scientific progress and problems that may arise during the COVIDRED 7 handling of any kind of fraud unethical behavior and breach of procedures and together with the coordinator and General Assembly GA propose corrective actions to the MB

First report from the advisory board

Task 71 Scientific coordination and progress management M1 M18 UMCU all Task 71 will involve 1 preparation of annual implementation plans 2 overall scientific coordination of research activities and monitoring of progress within WPs to ensure fulfilment of all project aims objectives and deliverables 3 supporting WP leaders integrating partners within their WP as well as ensuring smooth transfer of results between WPs 4 guidance of consortium compliance with ethics and research integrity requirements 5 installation of a Managing Board MB responsible for scientific review of WP reports scientific quality progress and results risk assessmentmanagement as well as fulfilment of deliverables and milestones 6 installation of an external Advisory Board AB that will be provided with a charter for its tasks and responsibilities invited to the kickoff and quarterly meetings and be asked to provide a review report to the MB in order to discuss and give feedback on the scientific progress and problems that may arise during the COVIDRED 7 handling of any kind of fraud unethical behavior and breach of procedures and together with the coordinator and General Assembly GA propose corrective actions to the MB

Report describing internal and external communication outputs

TASK 72 Communication management M1M18 UMCU allThe COVIDRED consortium will use various communication activities to promote the outcomes and results of the project and ultimately support the overall project goals During the grant agreement phase as well as during the first 6 months of the project the COVIDRED consortium UMCU will take the lead will further specify the most suitable communication activities including timelines To ensure effective communication COVIDRED will enact the following communication strategies I Internal quarterly project meetings regular teleconferences to report on project progress circulation of project reports and deliverables for revision among partners internal sharing of results and protocols foster integration of SMEs and links to academic and EFPIA partnersII External publication of results in highimpact peerreviewed journals granting open access of the results after all IP protection measures have been taken into account oral or poster presentations at international conferences and local events collaboration with other relevant European projects to maximize the impact of EU funded research reach out to scientific societies educational institutions and patient organizations invitation of scientific and clinical stakeholders such as patient organizations and scientific societies to participate in the consortium quarterly meetings and engage in discussion with the partners organization of specific activities such as specialized workshops to discuss relevant issues especially realworld implementation In addition we will build a project website

Regulatory management plan

TASK 63 Develop and execute regulatory plan M6 M24 Julius Clinical UMCUTask 63 aims to produce guidance for the consortium and external stakeholders on roles and responsibilities of different regulatory agencies at European and national levels and their decisionmaking pathways when assessing remote monitoring systems for use in epidemiologic monitoring and other relevant fields This task will 1 ensure all partners understand the qualification and decisionmaking pathways of regulatory authorities 2 plan potential engagement with regulatory authorities to facilitate adoption of new methods for remote monitoring of infectious disease in collaboration with WP14 and 3 develop a checklist of best practices for settingup remote monitoring technologies as new strategies for current and future epidemics as well as to help more efficiently allocate scarce resources for monitoring diagnosis and early treatment This task will be based on the results of task 62

First biannual report on COVID-RED progress, including ethics report and impact assessment

Task 71 Scientific coordination and progress management M1 M18 UMCU all Task 71 will involve 1 preparation of annual implementation plans 2 overall scientific coordination of research activities and monitoring of progress within WPs to ensure fulfilment of all project aims objectives and deliverables 3 supporting WP leaders integrating partners within their WP as well as ensuring smooth transfer of results between WPs 4 guidance of consortium compliance with ethics and research integrity requirements 5 installation of a Managing Board MB responsible for scientific review of WP reports scientific quality progress and results risk assessmentmanagement as well as fulfilment of deliverables and milestones 6 installation of an external Advisory Board AB that will be provided with a charter for its tasks and responsibilities invited to the kickoff and quarterly meetings and be asked to provide a review report to the MB in order to discuss and give feedback on the scientific progress and problems that may arise during the COVIDRED 7 handling of any kind of fraud unethical behavior and breach of procedures and together with the coordinator and General Assembly GA propose corrective actions to the MB

Report describing sustainability plan

TASK 75 Sustainability and business development M6 M18 UMCU AVA Roche The applicant consortium with input from industry partners will develop the sustainability plan for the maintenance and future development of project outcomes including identification of additional business models beyond those making the use of datasets for commercial developments subjected to fees whilst facilitating open access for research purposes described in WP4 The consortium will employ the following proven phased approach to implement a successful sustainability strategy 1 mapping identifying valuable use cases for a repository of COVID19 datasets as well as further applications of the remote monitoring system beyond COVID19 by assessing key clinicalsocietal needs marketcommercial opportunities and operationaltechnical feasibility inventorying possible strategic partners and investigating best practices amongst comparable initiatives 2 brainstorming business case development 3 validating together with a selection of key stakeholders and possible funderspayers the business cases will be validated including costeffectiveness modelling 4 planning positive business cases will be further detailed in a sustainability plan 5 business development activities promotions for industry and notforprofit organisations and contacts key fundersdecision makerspayers will be initiated to realize seed fundinginitial revenuecommercial deals The sustainability plan will present a roadmap for longterm sustainability of the consortium and network after the official end of COVIDRED to ensure that this valuable collaborative effort will endure

Testing protocols

TASK 21 Develop protocols and procedures for testing and for followup of positive cases M1M3 UMCU Julius Clinical Roche Sanquin Risch Risch ServicesWe will develop protocols and procedures for SARSCoV2 molecular testing of subjects that generate a positive signal based on the semicontinuous measuring approach andor the selfreported outcomes see Task 22 As part of this task we will also develop an appropriate procedure for followingup of positive cases In addition we will develop protocols and procedures for serological sampling and testing to determine which participants were exposed to SARSCoV2 during the study see Task 23

Final report on testing results for SARS-CoV-2 virus and SARS-CoV-2 antibodies

TASK 22 Testing study participants for SARSCoV2 virus M1M18 Roche Risch Risch servicesDuring the cohort study positive signals that are generated by the algorithm developed in WP1 will be followed up by molecular SARSCoV2 testing In the Netherlands anyone with respiratory symptoms can be tested freeofcharge for the SARSCoV2 virus as of 1 June 2020 The government aims to provide a test result within 24 hours and anyone who tests positive is automatically transferred to the public contacttracing programme We will therefore evaluate the possibility of asking study participants with a positive signal to attend the nearest public testing site and to share the testing information with the study team Some participants may not have access to public testing for example because they do not have overt symptoms and these participants will be tested by the study team In the Principality of Liechtenstein people with symptoms of COVID19 are recommended to be tested by a COVID19 RTPCR assay This test is covered by mandatory health insurance In addition individuals without symptoms wanting to be tested can also get an RTPCR test on their own cost The Liechtenstein RTPCR testing is done in a central lab labormedizinisches zentrum Dr Risch which is accredited according to ISO 17025 The laboratory is officially recognized by the Liechtenstein and Swiss office of Public Health for testing of SARSCoV2 virus and represents one of the Swiss testing labs accomplishing the highest test volumes Study participants are asked to get tested as soon as they have symptoms compatible with COVID19 For this purpose they can consult the national drivethrough testing site their family physician or the emergency room of the national hospital Should participants use testing abroad they will be asked to provide the result Alternatively the study team contacts the national office of Public Health which knows all the cases of notifiable diseases including COVID19 The COVIGAPP study is run by the study team of the national laboratory running almost all COVID19 tests in the country RTPCR testing for SARSCoV2 is done using the Roche cobas SARSCoV2 Test designed for use on the cobas 6800 or cobas 8800 instruments These instruments are available at the central laboratory of the Dutch blood bank Sanquin and other locations including the labormedizinisches zentrum Dr Risch in Buchs Switzerland The test is a singlewell dual target assay which includes both specific detection of SARSCoV2 and of the sarbecovirus subgenus family that includes SARSCoV2 Roche has committed 60008000 SARSCoV2 tests to this study This capacity may not be needed given the fact that we will possibly refer most participants to public testing sites in which case we will test a subset of participants for additional respiratory pathogens such as influenza and RSV The signs and symptoms caused by these pathogens are similar to those caused by COVID19 and this additional testing will improve our ability to determine the WP1 algorithms specificity The participants selected for this substudy will attend a public testing site but in addition they will selfcollect a nasopharyngeal swab at home and store it in a freezer until transport to the laboratory If possible samples could be analysed for several respiratory pathogens using the Roche platform TASK 23 Testing study participants for SARSCoV2 antibodies M10M18 Sanquin RischAll 30000 participants in the Dutch cohort study will provide a finger prick blood sample which they can do at home at their baseline visit and at the end of their followup period endline All endline samples will be tested for SARSCoV2 antibodies using an inhouse ELISA method in the central laboratory of Sanquin Stored baseline samples of participants who have a positive ELISA at endline will also be tested to determine whether the participant was alr

Updated data capture and transmission strategies

TASK 14 Creating the necessary data infrastructure for data extraction and analysis M1M22 Ava Julius Clinical Takeda UCLIn order to make sure that the data generated can be included in the data platform in WP4 we will review analyse and adjust the data generating mechanisms of the app and the bracelet It is expected that the major work will be done in four phases 1Set up M1 M62Data collection cleaning filtering storage and transfer M7 M183Data analysis M8 M224Reporting M1 M24

Data management plan (3rd iteration)

TASK 51 Data Management Plan M1M2 with updates during project Roche Ava UCL Takeda To ensure the most efficient exploitation of data generated in the project a Data Management Plan will be prepared and it will be updated throughout the project Existing experience will be maximally used for this The data management plan will contain A declaration of compliance with regard to national legislation relating to the rights of data subjects or the processing of genetic biometric andor health data depending on data type collected eg no genetic data is currently being considered for collectionThe name and contact details of the Data Protection Officer DPO as will be provided to data subjectsA description of the data that is processed and why it complies with the data minimisation principle for the purposes of the projectA description of which data will contain identified data with a rationale and which data will containpseudonymised data and the procedures which will be used to convert all data to pseudonymised data when migrated to the central data platform A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing those dataIn case personal data are transferred from the EU to a nonEU country it will be described how such a transfer will occur in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPRIn case personal data are transferred from a nonEU country to the EU it will be described how such transfers comply with the laws of the country in which the data was collectedDetailed information on the specific data protection provided within the informed econsent procedures in regard to data processing How informed econsent forms and information sheets in language and terms intelligible to the participants are kept onfile They can be provided to IMI JU upon requestTo what extent profiling will be involved in the research and how in the cases that this occurs ethics issues will be addressed before the project will progressIn case of further processing of previously collected personal data we will describe how we safeguard that the concerned consortium member has a lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjectsWe will describe how we will screen our data processing activities for ethics risks including an opinion whether the projects uses cases should have an accompanying data protection impact assessment conducted under art 35 GDPR 2016679 Data will be made FAIR findable accessible interoperable and reusable and the DMP will include information on data handling data types methodologies and standards used which data will be shared eg via Open Access and how data will be curated and preserved including after the end of the project The consortium will determine whether the FAIR principles will be met using a deidentified data approach a pseudoanonymized data approach or a Personal Health Train approachAt two important points in time before first patient in and halfway through the study completion the DMP will be updated and maintained on an annual basis thereafter The DMP will be kept up to date with the needs of the action and as such be updated as necessary during its lifetime

Data management plan (2nd iteration)

TASK 51 Data Management Plan M1M2 with updates during project Julius Clinical Roche Ava UCL Takeda To ensure the most efficient exploitation of data generated in the project a Data Management Plan will be prepared and it will be updated throughout the project Existing experience will be maximally used for this The data management plan will contain A declaration of compliance with regard to national legislation relating to the rights of data subjects or the processing of genetic biometric andor health data depending on data type collected eg no genetic data is currently being considered for collectionThe name and contact details of the Data Protection Officer DPO as will be provided to data subjectsA description of the data that is processed and why it complies with the data minimisation principle for the purposes of the projectA description of which data will contain identified data with a rationale and which data will containpseudonymised data and the procedures which will be used to convert all data to pseudonymised data when migrated to the central data platform A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing those dataIn case personal data are transferred from the EU to a nonEU country it will be described how such a transfer will occur in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPRIn case personal data are transferred from a nonEU country to the EU it will be described how such transfers comply with the laws of the country in which the data was collectedDetailed information on the specific data protection provided within the informed econsent procedures in regard to data processing How informed econsent forms and information sheets in language and terms intelligible to the participants are kept onfile They can be provided to IMI JU upon requestTo what extent profiling will be involved in the research and how in the cases that this occurs ethics issues will be addressed before the project will progressIn case of further processing of previously collected personal data we will describe how we safeguard that the concerned consortium member has a lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjectsWe will describe how we will screen our data processing activities for ethics risks including an opinion whether the projects uses cases should have an accompanying data protection impact assessment conducted under art 35 GDPR 2016679 Data will be made FAIR findable accessible interoperable and reusable and the DMP will include information on data handling data types methodologies and standards used which data will be shared eg via Open Access and how data will be curated and preserved including after the end of the project The consortium will determine whether the FAIR principles will be met using a deidentified data approach a pseudoanonymized data approach or a Personal Health Train approachAt two important points in time before first patient in and halfway through the study completion the DMP will be updated and maintained on an annual basis thereafter The DMP will be kept up to date with the needs of the action and as such be updated as necessary during its lifetime

Data management plan (final version)

TASK 51 Data Management Plan M1M2 with updates during project Roche Ava UCL TakedaTo ensure the most efficient exploitation of data generated in the project a Data Management Plan will be prepared and it will be updated throughout the project Existing experience will be maximally used for this The data management plan will contain A declaration of compliance with regard to national legislation relating to the rights of data subjects or the processing of genetic biometric andor health data depending on data type collected eg no genetic data is currently being considered for collectionThe name and contact details of the Data Protection Officer DPO as will be provided to data subjectsA description of the data that is processed and why it complies with the data minimisation principle for the purposes of the projectA description of which data will contain identified data with a rationale and which data will containpseudonymised data and the procedures which will be used to convert all data to pseudonymised data when migrated to the central data platform A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing those dataIn case personal data are transferred from the EU to a nonEU country it will be described how such a transfer will occur in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPRIn case personal data are transferred from a nonEU country to the EU it will be described how such transfers comply with the laws of the country in which the data was collectedDetailed information on the specific data protection provided within the informed econsent procedures in regard to data processing How informed econsent forms and information sheets in language and terms intelligible to the participants are kept onfile They can be provided to IMI JU upon requestTo what extent profiling will be involved in the research and how in the cases that this occurs ethics issues will be addressed before the project will progressIn case of further processing of previously collected personal data we will describe how we safeguard that the concerned consortium member has a lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjectsWe will describe how we will screen our data processing activities for ethics risks including an opinion whether the projects uses cases should have an accompanying data protection impact assessment conducted under art 35 GDPR 2016679 Data will be made FAIR findable accessible interoperable and reusable and the DMP will include information on data handling data types methodologies and standards used which data will be shared eg via Open Access and how data will be curated and preserved including after the end of the project The consortium will determine whether the FAIR principles will be met using a deidentified data approach a pseudoanonymized data approach or a Personal Health Train approachAt two important points in time before first patient in and halfway through the study completion the DMP will be updated and maintained on an annual basis thereafter The DMP will be kept up to date with the needs of the action and as such be updated as necessary during its lifetime

Full data management plan (1st iteration)

TASK 51 Data Management Plan M1M2 with updates during project Julius Clinical Roche Ava UCL Takeda To ensure the most efficient exploitation of data generated in the project a Data Management Plan will be prepared and it will be updated throughout the project Existing experience will be maximally used for this The data management plan will contain A declaration of compliance with regard to national legislation relating to the rights of data subjects or the processing of genetic biometric andor health data depending on data type collected eg no genetic data is currently being considered for collectionThe name and contact details of the Data Protection Officer DPO as will be provided to data subjectsA description of the data that is processed and why it complies with the data minimisation principle for the purposes of the projectA description of which data will contain identified data with a rationale and which data will containpseudonymised data and the procedures which will be used to convert all data to pseudonymised data when migrated to the central data platform A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing those dataIn case personal data are transferred from the EU to a nonEU country it will be described how such a transfer will occur in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPRIn case personal data are transferred from a nonEU country to the EU it will be described how such transfers comply with the laws of the country in which the data was collectedDetailed information on the specific data protection provided within the informed econsent procedures in regard to data processing How informed econsent forms and information sheets in language and terms intelligible to the participants are kept onfile They can be provided to IMI JU upon requestTo what extent profiling will be involved in the research and how in the cases that this occurs ethics issues will be addressed before the project will progressIn case of further processing of previously collected personal data we will describe how we safeguard that the concerned consortium member has a lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjectsWe will describe how we will screen our data processing activities for ethics risks including an opinion whether the projects uses cases should have an accompanying data protection impact assessment conducted under art 35 GDPR 2016679 Data will be made FAIR findable accessible interoperable and reusable and the DMP will include information on data handling data types methodologies and standards used which data will be shared eg via Open Access and how data will be curated and preserved including after the end of the project The consortium will determine whether the FAIR principles will be met using a deidentified data approach a pseudoanonymized data approach or a Personal Health Train approachAt two important points in time before first patient in and halfway through the study completion the DMP will be updated and maintained on an annual basis thereafter The DMP will be kept up to date with the needs of the action and as such be updated as necessary during its lifetime

Contact database of stakeholders and key project contacts

Task 71 Scientific coordination and progress management M1 M18 UMCU all Task 71 will involve 1 preparation of annual implementation plans 2 overall scientific coordination of research activities and monitoring of progress within WPs to ensure fulfilment of all project aims objectives and deliverables 3 supporting WP leaders integrating partners within their WP as well as ensuring smooth transfer of results between WPs 4 guidance of consortium compliance with ethics and research integrity requirements 5 installation of a Managing Board MB responsible for scientific review of WP reports scientific quality progress and results risk assessmentmanagement as well as fulfilment of deliverables and milestones 6 installation of an external Advisory Board AB that will be provided with a charter for its tasks and responsibilities invited to the kickoff and quarterly meetings and be asked to provide a review report to the MB in order to discuss and give feedback on the scientific progress and problems that may arise during the COVIDRED 7 handling of any kind of fraud unethical behavior and breach of procedures and together with the coordinator and General Assembly GAM propose corrective actions to the MB

Initial CRF development completed

Task 53 CRF Development M3M18 Julius Clinical UCL AvaIt is essential that the CRFs are robust for the various planned and unplanned scientific questions which will be posed against the study data To that end the choice of questions structure of responses and timing of the questions will be carefully considered during the protocol development and the CRFs will be designed in parallel Best epidemiology practices will be incorporated into the CRF design Additionally the database which underlies the CRFs is flexible to modifications during the study with full transparency The CRF will take into consideration COVID19 data collection standards such as the WHO case record forms

Project website, templates, and social media tools

TASK 61 Develop dissemination and exploitation plan M1M18 UMCU AvaTask 61 will develop and implement a strategic dissemination strategy WP lead and coleads will review the strategy regularly to ensure effective implementation The dissemination strategy will outline specific tools such as conferences and congresses scientific publications social media and newsletters to ensure COVIDRED progress and outcomes have impact beyond the scope of defined project activities In order to align all parties on dissemination standards and present a strong external facing image dissemination activities will first focus on project presentation after which the focus will shift to publishing progress and community buildingI Presenting the project M1M4 ie preparing different societal actors for COVIDRED and attracting their interest Actions 1 generation of a strong visual COVIDRED identity logo manual templates 2 development of a public website to serve as the projects showcase and main repository for communication materials including a web domain 3 generation of an initial communication pack animation and poster infographics to present the project to a broad audience 4 setting up social media accounts according to ECs guidance note on social media 042018 and launch an initial promotional campaign 5 creation of communication materials to present COVIDRED at specialized events and to foster exploitation and dissemination actions 6 development of an advanced communication analysis including a comprehensive study of issues affecting the communication activities with a particular emphasis on the context challenges and opportunities for the communication of benefits and challenges related to remote monitoring of COVID19 and other possible pandemics at a European and global levelII Publish project progress and build a community M4M18 ie promoting the project reporting its progression main milestones and project related topics Actions 1 development of a social media strategy with regular and original content creation and monthly metrics analysis 2 regular updates in the project blog progress updates partner presentations news 3 publication strategy press dossier and releases graphical and audiovisual content writing of articles and eNewsletters 4 development of audiovisual materials covering projectrelated topics 5 appointment of an COVIDRED Ambassador to represent the consortium in educational and outreach activities The communication strategy outlined above will be regularly monitored reviewed and updated to maximize the impact among all the stakeholders in this way setting the basis for successful uptake and implementation of COVIDRED results and methodologies

COVID-19 infections - Remote Early Detection

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