A randomised controlled trial to assess the ability of doxycycline to reduce the need for ICU admission in patients with proven COVID-19 infection (DOXPREVENT.ICU)

The study is a randomized open label parallel group clinical trial.

We propose a pragmatic clinical trial to test oral doxycycline as a therapy for newly hospitalized COVID-19 patients who are at high risk for progression to severe disease, with the main objective to reduce the burden of critical care (CC) services resulting from admission of severe patients in CC facilities.

The choice of doxycycline is based on its broad antimicrobial efficacy, including antiviral properties; recent in silico analyses identifying it as a potential strong inhibitor of NSP5, a key pathogenic protein of SARS-CoV-2; its targeted anti-inflammatory properties and efficacy in human virus-induced hyperinflammation (in dengue fever); as well as its excellent safety profile, pharmacokinetic properties, low price, and its world-wide availability due to its status a one of the essential medicines defined by the WHO.

Participants randomized to the interventional arm will take doxycycline 200 mg qd on top of the standard of care care whereas the standard care arm will not receive any doxycycline.

Follow-up: patients discharged before the 14-day period of expected follow up will be contacted by telephone 2 days after discharge (to ensure they are well and convalescing well) and on day 14 (by telephone).