COVID-19 Projects & Trials Update
Since the start of the pandemic last year, the COMBACTE network supports and closely collaborates with the EU-funded RECOVER project, as well as other COVID-19 trials.
Together with 10 academic international partners, COMBACTE closely collaborates with the RECOVER consortium, founded to address the most urgent COVID-19 related questions for patient and public health. COMBACTE is putting forward its established clinical and laboratory network (CLIN-Net and LAB-Net) to aid the clinical trials involved.
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 ongoing.
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 allow for broader geographical coverage across Europe, more and targeted biological sampling, and enriching the cohort, the MERMAIDS ARI 2.0 study was set up. On 14 September 2021, MERMAIDS ARI 2.0 included its targeted number of 300 patients in 11 sites across 7 European countries. Patients remain in follow-up up to 12 months after discharge. Despite the challenging COVID-19 situation throughout Europe, participating sites showed a big effort to recruit patients, and more than 4000 samples were collected. These samples are currently being analysed to study the genetic and immunological differences between the different included patient categories.
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 219 sites are participating. REMAP-CAP enrolled 5700 patients suspected or proven to have COVID-19 in Europe alone. Globally, the trial has enrolled over 8200 patients proven or suspected to have COVID-19. The patients in Europe have led to more than 11.000 randomisations over the existing study domains. REMAP-CAP published their newest results on the use of Heparin in patients with COVID-19 on August 4th in the prestigious New England Journal of Medicine.
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 got the oppurtinity to do site selection for this study in the European arm.
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 leg 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 7000 healthcare workers have been enrolled worldwide, including 595 healthcare workers in the Netherlands and 227 healthcare workers in Spain. The study progress in Europe is on track with the 12-month follow-up visits being conducted in the Netherlands and 9-month follow up visits being conducted in Spain. The follow up phase of the trial consists of 3-monthly questionnaires and blood collection, as well as ongoing data collection via the trial’s custom-built smartphone app, and will continue until February 2022.
Related updates
“We Take Bigger Steps Together”
COMBACTE's Last General Assembly
COMBACTE Launches Last Magazine
COMBACTE launched its last magazine at ECCMID 2023 in Copenhagen. The magazine focuses on project’s impact, and features articles and interviews with ...