Phase II study of AT-527 in adults with mild or moderate COVID-19 [COVID-19]
Research type
Research Study
Full title
A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE ANTIVIRAL ACTIVITY, SAFETY, PHARMACOKINETICS, AND EFFICACY OF RO7496998 (AT-527)IN NON HOSPITALIZED ADULT PATIENTS WITH MILD OR MODERATE COVID-19
IRAS ID
293134
Contact name
Karishma Singh
Contact email
Sponsor organisation
F. Hoffmann La Roche Ltd.
Eudract number
2020-005366-34
Duration of Study in the UK
0 years, 2 months, 23 days
Research summary
Summary of research
This is a clinical research study of a potential new drug, AT-527 (also known as RO7496998), in non-hospitalised adults with mild or moderate COVID-19.
COVID-19 infection may be asymptomatic, or it may cause a wide spectrum of illness ranging from a mild upper respiratory tract infection to severe life-threatening sepsis and multi-organ failure. Commonly reported symptoms include fever, cough, shortness of breath, loss of taste or smell, sore throat, fatigue, headaches, muscle aches and gastrointestinal disturbance.Currently there are no approved vaccines or treatments for participants with mild or moderate COVID-19, which is by far the most frequent presentation of the disease. AT-527 is an oral tablet which may significantly reduce the deterioration of participants, preventing progression of disease or hospitalisation.
The study will include approximately 220 participants, who will be in the study for a maximum of 33 days.
Following screening, participants will be enrolled into one of 5 treatment cohorts (A-E), each will test a different dose level of AT-527. There will be 60 participants in Cohort A, and Cohorts B-E will enrol 40 participants each. In Cohort A, participants will be randomised in a 1:1 ratio to receive either AT-527 550mg (or placebo) twice daily (BID) for 5 days. Data review will be performed after all enrolled participants in Cohort A (and cohorts B,C,D as applicable) have completed assessments up to Day 10, to determine the AT-527 dose for the following cohort. In cohorts B-E participants will be randomised in a 3:1 ratio to receive either AT-527 or placebo for 5 days. Maximum dose tested will be 1100mg BID for 5 days.
The study involves procedures including vital signs, physical examinations, Electrocardiogram (ECG), blood, saliva and urine sample testing, nasal swabs, and completion of diaries.
The study is sponsored by F. Hoffmann-La Roche Ltd.
Summary of results
Researchers looked at the amount of virus in the nose and throat of people with COVID-19 before and after they had taken the study medicine – to see if bemnifosbuvir could reduce the amount of virus better than placebo.
Bemnifosbuvir did not reduce the amount of virus in people’s nose and throat better than placebo:
• People who were given 550 mg bemnifosbuvir (Group A) had a similar amount of virus in their nose and throat after treatment as people who were given placebo.
• People who were given 1100 mg bemnifosbuvir (Group B) also had a similar amount of virus in their nose and throat after treatment as people who were given placebo.This outlines only the key results from the study.
REC name
London - Riverside Research Ethics Committee
REC reference
20/HRA/6080
Date of REC Opinion
13 Jan 2021
REC opinion
Further Information Favourable Opinion