Periodic Reporting for period 3 - RECoVER (Rapid European SARS-CoV-2 Emergency research Response)
Reporting period: 2022-02-14 to 2023-08-13
RECOVER (Rapid European COVID-19 Emergency Research response) was a 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 integrated (1) clinical studies, (2) clinical biological studies, and (3) epidemiological studies and modelling.
In the course of the project, RECOVER and EU-RESPONSE have joined forces to install a Trial Coordination Board and a Joint Access Mechanism to ensure a coordinated strategy of the European COVID-19 Adaptive Platform Trials.
Conclusions:
- RECOVER highlighted the critical importance to prepare for pandemic outbreaks of infectious diseases. In the REMAP-CAP study, the master protocol included a pandemic appendix, which allowed to launch that protocol within weeks after the outbreak was declared a public health emergency of international concern by WHO. A second aspect is the need for warm-base clinical networks, both in hospital settings and primary care settings. Having this infrastructure in place, RECOVER was able to kick-start its clinical trials.
- There is an urgent need for improved coordination of clinical trial funding on a Member States level. The solution lies in the development of a mechanism for the coordination of funding of clinical research studies and clinical trials in Europe. In parallel, we also need to install an instrument to prioritize research during a pandemic, all in the aim to prevent fragmentation of efforts and resources and, therefore to more rapidly response to the next health threat.
In the course of the project, RECOVER and EU-RESPONSE have joined forces to install a Trial Coordination Board and a Joint Access Mechanism to ensure a coordinated strategy of the European COVID-19 Adaptive Platform Trials.
Conclusions:
- RECOVER highlighted the critical importance to prepare for pandemic outbreaks of infectious diseases. In the REMAP-CAP study, the master protocol included a pandemic appendix, which allowed to launch that protocol within weeks after the outbreak was declared a public health emergency of international concern by WHO. A second aspect is the need for warm-base clinical networks, both in hospital settings and primary care settings. Having this infrastructure in place, RECOVER was able to kick-start its clinical trials.
- There is an urgent need for improved coordination of clinical trial funding on a Member States level. The solution lies in the development of a mechanism for the coordination of funding of clinical research studies and clinical trials in Europe. In parallel, we also need to install an instrument to prioritize research during a pandemic, all in the aim to prevent fragmentation of efforts and resources and, therefore to more rapidly response to the next health threat.
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. It revealed that patients with SARS-CoV-2 took longer to recover, however, at day 28, a similar percentage as in the SARS-CoV-2 negative patients experienced residual symptoms.
MERMAIDS-ARI
Between March 2020 and July 2022, a total of 949 participants were recruited, adding up to 2,476 enrollments since initial start of the study in PREPARE in 2015. 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. In this study, 94.3% of employed patients had returned to work 3 months after discharge while 11.3% had to make significant changes to their work duties or occupation because of their hospital stay. 86.5% of unemployed patients (including retirement) had resumed their usual activities.
REMAP-CAP
The REMAP-CAP study aims to determine the optimal treatment regimens for patients with severe community-acquired pneumonia (CAP). REMAP-CAP was designed to adapt and speed up research in the event of a pandemic. During COVID, the pandemic appendix was activated and we had 217 active sites participating in this trial. We have included 7,362 patients in the trial in Europe, totaling 13,950 randomizations (as patients can be randomized to more than one intervention). During the RECOVER funding period, REMAP-CAP reached 14 conclusions directly impacting patient care. We have shown, f.i. that in critically ill patients with Covid-19 receiving organ support in ICUs, treatment with the interleukin-6 receptor antagonists tocilizumab and sarilumab improved outcomes, including survival.
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. Research 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. An additional qualitative survey was carried out 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 had also conducted interviews with patients and general practitioners to generate an understanding of their perspectives in receiving and providing primary care during the pandemic.
In conclusion, RECOVER had a unique impact in terms of scientific outcomes, patient management and public health policy:
- over 100 publications in peer-reviewed journals
- contributed to developing one of the first PCR tests to detect the SARS-CoV-2 virus
- developed some of the first tools to model the disease, which helped us better understand the spread of the virus
- did some of the first studies to better understand asymptomatic transmission of the virus, which was a major point of discussion notably at beginning of the pandemic
- executed some pivotal studies to better understand the transmission of the virus in schools and among healthcare workers
- carried out several observational studies and clinical trials to answer questions including: what are the risk factors for infection? How does the virus transmit? How you can prevent transmission? What kind of treatments are effective against COVID-19?
- since we embedded social sciences in our clinical research, trial results were also used to inform guidelines, including ECDC and WHO guidelines.
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. It revealed that patients with SARS-CoV-2 took longer to recover, however, at day 28, a similar percentage as in the SARS-CoV-2 negative patients experienced residual symptoms.
MERMAIDS-ARI
Between March 2020 and July 2022, a total of 949 participants were recruited, adding up to 2,476 enrollments since initial start of the study in PREPARE in 2015. 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. In this study, 94.3% of employed patients had returned to work 3 months after discharge while 11.3% had to make significant changes to their work duties or occupation because of their hospital stay. 86.5% of unemployed patients (including retirement) had resumed their usual activities.
REMAP-CAP
The REMAP-CAP study aims to determine the optimal treatment regimens for patients with severe community-acquired pneumonia (CAP). REMAP-CAP was designed to adapt and speed up research in the event of a pandemic. During COVID, the pandemic appendix was activated and we had 217 active sites participating in this trial. We have included 7,362 patients in the trial in Europe, totaling 13,950 randomizations (as patients can be randomized to more than one intervention). During the RECOVER funding period, REMAP-CAP reached 14 conclusions directly impacting patient care. We have shown, f.i. that in critically ill patients with Covid-19 receiving organ support in ICUs, treatment with the interleukin-6 receptor antagonists tocilizumab and sarilumab improved outcomes, including survival.
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. Research 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. An additional qualitative survey was carried out 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 had also conducted interviews with patients and general practitioners to generate an understanding of their perspectives in receiving and providing primary care during the pandemic.
In conclusion, RECOVER had a unique impact in terms of scientific outcomes, patient management and public health policy:
- over 100 publications in peer-reviewed journals
- contributed to developing one of the first PCR tests to detect the SARS-CoV-2 virus
- developed some of the first tools to model the disease, which helped us better understand the spread of the virus
- did some of the first studies to better understand asymptomatic transmission of the virus, which was a major point of discussion notably at beginning of the pandemic
- executed some pivotal studies to better understand the transmission of the virus in schools and among healthcare workers
- carried out several observational studies and clinical trials to answer questions including: what are the risk factors for infection? How does the virus transmit? How you can prevent transmission? What kind of treatments are effective against COVID-19?
- since we embedded social sciences in our clinical research, trial results were also used to inform guidelines, including ECDC and WHO guidelines.
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. At the end of RECOVER, we conducted a qualitative study on the lessons learned and published a comprehensive report. This report will inform the next steps: building a European Pandemic Preparedness Partnership, developing a coordination mechanisms for funding clinical research and studies by Member States during health threats, developing an outbreak response mode based on the mode document prepared in PREPARE, and organising table-top exercises.