In December 2019 the first patients with pneumonia of unknown aetiology in Wuhan, China were being reported to the WHO China Office. By the 24th of January the first cases of COVID-19 were recorded in Europe. A steep rise of confirmed cases of the novel Coronavirus (SARS-CoV-2) in patients across Europe and the world has been observed after this time. Within less than two months the WHO declared COVID-19 a pandemic.
With more than 1000 hospitals, the COMBACTE network is currently being used in identifying and activating sites that can participate in COVID-19 clinical trials, next to the regular COMBACTE clinical trials focusing on antimicrobial resistance. Site selection for these trials is being done as usual through CLIN-Net, COMBACTE’s clinical network, which has extensive experience in identifying suitable hospitals. The outbreak also has an impact on COMBACTE’s LAB-Net activities. Supported by its state-of-the-art laboratory expertise and 800 laboratories in its network, LAB-Net has stepped up to support COVID-19 clinical trials by assessing the routine clinical laboratory practices for COVID-19. Among COMBACTE’s laboratory network a survey on the level of preparedness of diagnostic laboratories for the detection of SARS-CoV-2 has been sent.
RECOVER is a consortium on rapid European COVID-19 emergency research response that aims to understand the pathophysiology and epidemiology of COVID-19, as well as identify potential targets for therapeutic or preventive interventions.
More specifically COMBACTE is involved in the site selection part of RECOVER’s work package 3 (WP3): an observational study to identify the prevalence, disease spectrum and severity, risk factors, spread and outcomes of COVID-19 in patients in hospital care (the emergency room and respiratory ward) in selected European countries. LAB-Net is also involved in WP3 for sample collection and management.
Another part of WP3 is a survey to assess perceptions and preparedness of European healthcare workers for COVID-19. Results will provide guidelines on how to protect valuable healthcare personnel. This information will help investigate infection prevention and control procedures in different countries and create awareness about healthcare workers’ perspectives. The survey has been sent to hospitals in the COMBACTE network.
Work Package 8 of RECOVER, REMAP-CAP, is an adaptive platform trial (APT) focused on determining the optimal set of treatments for patients with severe community-acquired pneumonia. As an adaptive platform, REMAP-CAP is specifically designed to adapt in the event of a pandemic, increasing the likelihood of patients receiving an effective treatment. Due to the continued global spread of COVID-19, the platform has extended its domains to investigate new treatments specifically for COVID-19 patients on the ICU and the ward. The aim is to improve outcomes for moderately or severely ill COVID-19 patients. With the ability to improve the design according to new insights and already having the clinical trial infrastructure in place to implement these insights swiftly, various interventions can be tested simultaneously within multiple therapeutic domains. REMAP-CAP is funded under the European Union’s Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) and the RECOVER consortia.
COMBACTE’s CLIN-Net is involved in the site selection in 20 European countries, and aims to select 250 sites.
BRACE is a multi-centre randomised clinical trial designed to test whether the BCG vaccine (Bacillus Calmette–Guérin), which boosts humans’ ‘frontline’ immunity, can protect healthcare workers exposed to SARS-CoV-2 from developing severe symptoms. BRACE was initially performed in Australia, but has been extended to healthcare workers in Europe. The COMBACTE network was used to perform site selection for the European part of the study.
Also find the most commonly asked questions and answers concerning the COVID-19 Case Report Form (CRF) tool from ISARIC via the link below.