Canada-based Appili Therapeutics has enrolled and dosed the first cluster of participants in its Phase II CONTROL COVID-19 clinical trial of favipiravir.
The cluster-randomised placebo-controlled trial will analyse the effectiveness of favipiravir as a preventative measure against Covid-19 outbreaks in long-term care (LTC) facilities.
Developed by FUJIFILM Toyama Chemical, favipiravir is an antiviral in oral tablet form. India and Russia have approved favipiravir-based antiviral medications for the emergency treatment of Covid-19.
This trial is part of Appili’s clinical programme intended to evaluate whether early administration of favipiravir can limit the spread and severity of Covid-19 in high-risk patients, including the elderly.
As per the study protocol, onset of an outbreak in an LTC facility unit, all consenting residents in that cluster will be given either favipiravir or a placebo.
The trail is expected to be conducted on roughly 760 participants at 16 LTC centres.
Participants will include elderly subjects with co-morbidities and front-line healthcare workers with recent Covid-19 exposure or confirmed infection.
Appili anticipates reporting topline data from the study next year.
The trial’s primary outcome will be control of the outbreak defined as no new microbiologically confirmed Covid-19 cases for a minimum of 24 consecutive days.
Appili Therapeutics managing director, chief medical officer Yoav Golan said: “Providing early access for vulnerable patients to antiviral therapy, particularly in a community setting, is a cornerstone of Appili’s Covid-19 clinical strategy.
“We believe favipiravir’s mechanism of action and oral tablet formulation will best serve patients in these conditions.”
In August, Appili secured clearance from the US Food and Drug Administration (FDA) to expand the Phase II Covid-19 clinical trial of favipiravir to LTC facilities in the country.