This is a randomised placebo controlled phase II trial to examine the efficacy ofantivirals to treat COVID-19 infection compared to placebo for virological cure andimproved clinical outcomes. Individuals will be randomised to the candidate antiviralwhich in the first instance is Favipiravir or matched placebo and randomisation will bestratified according to whether the participant requires hospitalisation or not. Thistreatment will be given in addition to the usual standard of care in the participatinghospital.
Drug: Favipiravir
Favipiravir
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
Alfred Health
Melbourne, Victoria, Australia