REMAP-CAP response to the
COVID-19 pandemic

REMAP-CAP has implemented the Pandemic Appendix to the Core Protocol so that the platform can respond rapidly in the event of widespread disease resulting from the novel 2019 coronavirus (COVID-19).

These changes include:

  • Modification of the primary end-point, so that information is available more quickly

  • Description of the statistical model that will be used to analyse data for patients with proven or suspected pandemic infection

  • Description of changes to statistical thresholds for declaring an intervention to be equivalent, superior, or inferior to another

  • Specification of pathways that permit the Data Safety Monitoring Board to liaise directly with public health authorities if REMAP-CAP produces results that are of relevance to public health

  • Modification of entry criteria and statistical model to enable enrolment of patients in different disease severity states, and to evaluate the differential efficacy of interventions depending on illness severity.

COVID-19 Domains

All participating sites will be able to participate in two existing domains that have relevance to the treatment of patients with severe CAP resulting from coronavirus. These are:

  • Evaluation of prolonged macrolide therapy, as a modulator of immune function

  • Evaluation of alternative corticosteroid strategies (no corticosteroids, low dose hydrocortisone for 7 days, or hydrocortisone while the patient is in septic shock)

  • Evaluation of a number of antiviral medications for COVID-19, including lopinavir/ritonavir (Kaletra), hydroxychloroquine, and ivermectin

  • Evaluation of no immune-modulating therapy for COVID-19 (and no placebo), Interferon-beta-1a, interleukin-1 receptor antagonist (Anakinra), tocilizumab and sarilumab

  • Evaluation of the use of convalescent plasma for COVID-19

  • Evaluating anticoagulation strategy for critically ill and non-critically ill patients with COVID-19

  • Evaluation the use of high-dose vitamin C for patients with severe CAP, including CAP caused by COVID-19

  • Evaluation of the use of simvastatin for COVID-19

  • Evaluation of the use of aspirin or a P2Y12 inhibitor (clopidogrel, prasugrel, or ticagrelor) compared to no antiplatelet therapy

  • Evaluation of angiotensin converting enzyme inhibitor (ACEi), angiotensin-II receptor blocker (ARB), an ARB in combination with a chemokine receptor-2 inhibitor, or no renin-angiotensin system inhibitor for patients with COVID-19

Additional interventions against COVID-19 are being considered and may be introduced into these domains. Current protocol documents for COVID-19 domains can be found here.

REMAP-CAP is also exploring options to increase the number of participating sites in current locations, as well as commencing recruitment in new countries.

REMAP-CAP has been named by the Chief Medical Officers of the United Kingdom as a key clinical trial for COVID-19. Read the statement here.