Rapid European SARS-CoV-2 Emergency research Response

Periodic Reporting for period 2 - RECoVER (Rapid European SARS-CoV-2 Emergency research Response)

Période du rapport: 2021-02-14 au 2022-02-13

RECOVER (Rapid European COVID-19 Emergency Research response) is comprehensive, multidisciplinary research response to the SARS-CoV-2 outbreak addressing the most urgent questions for patient and public health level interventions. To improve patient care and public health responses to the COVID-19 pandemic, RECOVER integrates (1) clinical studies, (2) clinical biological studies, and (3) epidemiological studies and modelling.

(1) RECOVER’s clinical studies are analysing the severity of COVID-19 in the form of observational studies taking place in both primary care and hospital sites across Europe. Through embedded social science research, we are improving our understanding of the experiences of healthcare professionals and patients in relation to the COVID-19 pandemic in order to improve delivery of care. The hospital sites will also be used to test new therapies and supportive treatments with patients with severe symptoms of COVID-19.

(2) The biological studies are developing the tools needed for the RECOVER clinical studies and are establishing protocols that laboratories involved in RECOVER can use to evaluate biological samples collected from patients with the virus. In addition, the biological studies aim to provide answers on the severity of the virus in humans compared to animal models and investigate how the virus’s genome changes with time.

(3) European policymakers need to determine which combination of control measures they plan to use in their countries. Having access to accurate information on how the virus spreads helps mitigating its impact on the population. RECOVER therefore studies the transmission features of the virus in Europe by using the data collected from confirmed cases in Europe and with mathematical modelling, simulate the spread under different infection control scenarios, such as quarantine and isolation. This allows different control strategies to be evaluated.

In addition, the adaptive platform trial REMAP-CAP, developed in PREPARE, is now continued in RECOVER. Also, RECOVER and EU-RESPONSE have joined forces to install a common mechanism to ensure a coordinated strategy of the European COVID-19 Adaptive Platform Trials.

SOS-COVID
The primary care observational study, SOS-COVID, aimed to generate evidence about milder and/or undiagnosed SARS-CoV-2 infection, risk factors for a complicated course of disease, as well as to track the impact of the disease when managed outside the hospital. Data analysis showed that of the non-hospitalised patients, 30% recovered within a week after presenting to their GP, another 50% within three weeks, and 16% not yet after a month. Of the 32% of patients presenting with short of breath, 43% recovered from this symptom within a week, and 15% not yet after a month. Analyses for key risk factors for a complicated course of COVID-19 illness are ongoing.

MERMAIDS ARI studies
The MERMAIDS ARI study had been launched as part of the PREPARE consortium and was reactivated in RECOVER. Since its reactivation, the study has included 930 patients, adding up to 2,457 enrollments since initial start of the study in PREPARE. To enable broad geographical coverage in Europe, increased and targeted biological sampling, inclusion of children and enrichment of the cohort, the MERMAIDS ARI 2.0 study was also set up. MERMAIDS ARI 2.0 stopped inclusions at 300 patients in September 2021. Data cleaning is being finalized. Descriptive statistics are being generated.

REMAP-CAP
The REMAP-CAP study aims to determine the optimal treatment regimen for patients with severe community-acquired pneumonia (CAP). REMAP-CAP was designed to adapt and speed up research in the event of a pandemic. We currently have 201 active sites and 14 active but not enrolling sites. Another 45 sites are in the start-up process, adding countries to the geographical spread of the trial to a total of 19 European countries.

We have now included 6,630 patients with COVID-19 in the trial in Europe, totaling 12,706 randomizations (as patients can be randomized to more than one intervention). We have 55 current or completed interventions investigated within 16 different domains. We continue to investigate the optimal treatment regime for COVID-19 patients and we will keep investigating repurposed as well as newly developed drugs, and other interventions, which can all be done in the trial.

Social sciences
The Social Sciences team developed a survey tool for hospital health professionals in Europe to assess their perceptions of local infection prevention and control measures and their general wellbeing. Two rounds of surveys covered a total of 2,289 health professionals from 26 European countries. Data and outcomes have been published in February 2022.

Research conducted in WP6 related to the needs and experience of household members informed discussions that fed into updated WHO guidelines on ‘Home care for patients with suspected or confirmed COVID-19 and management of their contacts’. A second round of data collection with younger members of households living with a person diagnosed with COVID-19 was completed in January 2021. Data analysis is near complete and a manuscript in preparation.

An additional qualitative survey was added to the project’s Description of Work to explore scientists’ views and experiences of advising European governments on COVID-19 research. Scientific advisors working during the pandemic indeed faced a number of challenges, taking on new, sometimes unanticipated roles, the boundaries of which were not clearly defined.

The Social Sciences team has also conducted interviews with patients and general practitioners to generate an understanding of their perspectives in receiving and providing primary care during the pandemic. Data collection was completed in 2020 and analysis was completed in 2021. Four papers have been published or are being prepared for publication.

Output
RECOVER’s output over the first two years of its funding period is quite exceptional, as the project now has over 100 publications online. These publications focus on the virus variants, possible treatments as well as people’s attitudes towards various corona-related issues. In addition, RECOVER investigators from various work packages published a viewpoint based on the experiences in the consortium in Lancet Infectious Diseases in December 2021, followed by complimentary publications by regulators and funders.

Through its clinical and social sciences research as described above, the RECOVER consortium expects to deliver a major contribution to the EU’s public health response to the COVID-19 pandemic. Collaboration with ECDC, WHO and other EU funded research projects is essential to translate our findings in adequate outbreak response measure. To that end, REMAP-CAP has collaborated with WHO in several publications. In addition, three of the laboratories in RECOVER are involved with the WHO task force on viral evolution, where global data and experimental studies are reviewed to grade newly emerging variants as variants of interest or variants of concern.

RECOVER researchers participated in five EC initiated online seminars that brought together representatives from the EU-funded project working on COVID-19 as well as experts from ECDC, EMA, and different directorates and units from DG HERA, DG SANTE and DG R&I to focus on epidemiological, clinical and societal questions with direct relevance for public health.

SOS COVID specimens analysed by country by PCR

Periodic Reporting for period 2 - RECoVER (Rapid European SARS-CoV-2 Emergency research Response)

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