COVID-19 Trials Starting Data Analysis

SOS-COVID

The RECOVER primary care observational study, SOS-COVID (work package 2), started in March 2020. In total, 885 patients with a respiratory tract infection were enrolled in the study via their general practitioner. The study enrolled patients from 9 different countries: the Netherlands, Belgium, Georgia, Spain, Germany, Moldova, Hungary, Ireland and Poland.

Of all enrolled patients, more than 25% tested positive for SARS-CoV-2, and the remainder had another cause of disease. Particularly in the beginning of the pandemic, when routine COVID-19 testing was not implemented yet, patients were not aware of the cause of their illness. This enabled the study team to generate evidence about milder and/or undiagnosed SARS-CoV-2 infection, differences in the course of COVID-19 as compared to other causes of respiratory tract infections, and about risk factors for a complicated course of COVID-19. Analysis of the study data is almost finalized.

MERMAIDS ARI STUDIES

The MERMAIDS ARI and MERMAIDS ARI 2.0 studies are part of work package 3 of RECOVER. Since its reactivation at the beginning of the pandemic, the MERMAIDS ARI study has included 783 patients across 38 study sites. To enable broad geographical coverage across Europe, increased and targeted biological sampling, inclusion of children and enrichment of the cohort, the MERMAIDS ARI 2.0 study was set up. The study reached its targeted enrolment of 300 patients, including 169 COVID-19 patients, in 7 European countries on 14 September 2021, and collected more than 4,000 samples. These samples are currently being analysed. The last patient follow-up visits are taking place until the summer, and the first site close-out visits are scheduled for the coming months.

The COMBACTE network is also supporting other COVID-19 trials.

REMAP-CAP

The REMAP-CAP study was designed to adapt and speed up research, especially in the event of a pandemic. Due to the continued global spread of COVID-19, the REMAP-CAP pandemic modus was activated in March 2020 and participating sites from all over the world started enrolling and randomising (suspected) COVID-19 patients. The study is currently active in 15 countries in Europe, and a total of 215 sites are participating. REMAP-CAP enrolled 6,661 patients suspected or proven to have COVID-19 in Europe alone. Globally, the trial has enrolled over 9,750 patients proven or suspected to have COVID-19. The patients in Europe have led to more than 13,250 randomisations over the existing study domains.

The European arm of REMAP-CAP was a trial within the PREPARE project, but has transitioned to the ECRAID-Base project since the end of PREPARE. COMBACTE’s CLIN-Net supported site selection for the European arm of the study. Over the course of a little over a year, a series of REMAP-CAP publications with results from the Pandemic Strata have been published.

BRACE STUDY

The BRACE study, initiated by the Murdoch Children’s Research Institute (MCRI), aims to determine if the BCG vaccine reduces the incidence and severity of COVID-19 disease in healthcare workers. COMBACTE’s CLIN-Net was approached by MCRI to select sites for the European arm of the study and selected 11 sites in the Netherlands and Spain. The trial has become the world’s largest trial on the off-target effects of the BCG vaccine. Almost 7,000 healthcare workers have been enrolled worldwide, including 595 healthcare workers in the Netherlands and 227 healthcare workers in Spain.

All 12-month follow-up visits have been completed in the Netherlands and Spain, as well as the site close-out visits in the Netherlands. The Spanish sites are expected to be closed in April/May of this year. Analysis of primary endpoints is ongoing, while analysis of secondary endpoints will start mid-2022.