Services in support of the KCE-study "The DAWN camostat trial: the efficacy of camostat for COVID-19 infections presenting to ambulatory care: a randomized controlled trial"

With this study, we aim to find out whether antiviral drugs are effective in treating symptomatic COVID-19 patients. Two antiviral drugs will be tested: camostat, a drug that has been on the market for over 30 years in Japan and other Asian countries, and molnupiravir, an oral antiviral treatment that was initially developed for treatment of influenza, and has a good safety profile. Patients who are 40 or older, presenting to their GP or local primary care triage point with recent COVID-19 symptoms (for a maximum of 5 days) are eligible for the trial if SARS-CoV-2 infection is confirmed using a rapid antigen or PCR test and if they do not need hospital admission at that time. If patients consent to be included in the trial, they will be randomly assigned to either camostat, molnupiravir or placebo, randomised 1:1:1 between the 3 arms. For up to 30 days after inclusion, patients are asked to fill in a symptom diary every day. This can be done either by using a smartphone app, on the computer or on paper, whatever is most convenient for the patient. Patients will be phoned on day 2, 4 and day 30 by a study nurse, to ask about symptoms, side effects and any other queries the patients may have. Patients will also be visited by a study nurse on day 8. The primary target for evaluating the antivirals are whether they can reduce the time to self-reported recovery. 474 patients will be included in the trial. Other outcomes include their effect on hospitalisation, death, symptom recovery, severity of COVID-19 and quality of life.

Keywords:PRIMARY CARE, COVID-19, ANTIVIRAL DRUGS

Disciplines:Infectious diseases, Respiratory medicine, Primary health care

Project type:Service project