drugset
drugset / Trial / NCT04448119

Control of COVID-19 Outbreaks in Long Term Care

NCT04448119 ↗

Phase 2 Terminated 67 enrolled Appili Therapeutics Inc. Applied Health Research Centre · collabMOUNT SINAI HOSPITAL · collabSunnybrook Health Sciences Centre · collabUniversity Health Network, Toronto · collabUniversity of Toronto · collab
RandomizedParallel-groupQuadruple-blindPrevention

Summary

To address the need to intervene to prevent the spread of COVID-19 in long-term care homes, we propose a randomized clinical trial of chemoprophylaxis in long-term care homes experiencing COVID-19 outbreaks. LTCH units experiencing an outbreak of COVID-19 will be randomized to chemoprophylaxis with favipiravir or placebo in a 1:1 ratio. Chemoprophylaxis in this setting refers to the use of favipiravir for pre-exposure prophylaxis, post-exposure prophylaxis, pre-emptive therapy, or treatment for established COVID-19. This design mimics the approach to influenza outbreaks, which has proven efficacy for outbreak control. The primary outcome will be control of the outbreak, defined as no new microbiologically confirmed case of COVID-19 for 24 consecutive days up to day 40.

Timeline

Start
2020-10-16
Primary completion
2021-10-30
Completion
2021-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Favipiravir Small molecule 800 mg Oral
Subject Favipiravir Small molecule 1000 mg Oral

Indications

COVID-19