COMBACTE Mobilizes Network During Pandemic

In the three months since the COVID-19 outbreak was declared a pandemic, COMBACTE mobilized to provide support by putting forward its network of hospitals and laboratories. With more than 1000 hospitals and 800 laboratories, the 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, sites are now being approached for their participation in COVID-19 trials. 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 COMBACTE network is used in the following trials/projects:

RECOVER

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.

WP3 is an expansion of the MERMAIDS ARI study in the PREPARE consortium, as part of the new RECOVER consortium.

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.

LAB-Net Survey

A survey among COMBACTE’s LAB-Net – laboratory network – to assess the capacity and capability to detect the new coronavirus.

BRACE

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 will be used to perform site selection for the European part of the study.

REMAP-CAP for COVID

An extension of REMAP-CAP, which is a Randomised, Embedded, Multifactorial, Adaptive Platform trial. The broad objective of the REMAP-CAP study is, over time, to determine and continuously update the optimal set of treatments for community-acquired pneumonia. REMAP-CAP for COVID will investigate new specific treatments for COVID-19 in hospitalized patients on the ICU and on the ward. The aim is to improve outcomes for moderately or severely ill patients with COVID-19.  COMBACTE’s CLIN-Net is involved in the site selection in 20 European countries, and aims to select 250 sites.

Other COVID-19 Studies

Next to their involvement in COMBACTE clinical trials, members of COMBACTE are also leading and providing their expertise in other COVID-19 clinical trials.

• BCG Corona Trial – an interventional study in participating hospitals University Medical Center Utrecht and the Radboud University Medical Center, Nijmegen on efficacy of the BCG vaccine in preventing and/or mitigating COVID-19 infection in health workers working with COVID-19 patients. Not linked to the BRACE study. Its primary objective is to reduce absenteeism among healthcare workers with direct patient contacts during the epidemic phase of COVID-19. Co-led by Prof. Marc Bonten, COMBACTE’s Scientific Coordinator. Dr. Henri van Werkhoven is the Scientific Coordinator of the study, and has been involved in COMBACTE-NET’s ANTICIPATE study.
• COCON – Control of COVID-19 in hospitals –  Sero-epidemiology in healthcare workers – is an observational study with the primary objective to determine the seroprevalence of SARS-CoV-2 neutralising antibodies in healthcare workers in Dutch hospitals in areas with varying incidence of COVID-19 upon enrolment (baseline).  The study is led by Prof. Jan Kluytmans, academic lead of COMBACTE-NET’s ASPIRE-SSI and ASPIRE-ICU trials.