An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection

This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.

Inclusion Criteria:

• Provision of informed consent by the participant or authorized representative
• Age ≥18 years
• Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days
• COVID-19 related symptom initiation within 5 days
• Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.

Exclusion Criteria:

• Known allergy to the study medication
• Is on another antiviral for the treatment of COVID-19
• Pregnancy
• Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification
• Patients with renal impairment requiring dialysis
• Is deemed by the Investigator to be ineligible for any reason