An Adaptive Clinical Trial of Antivirals for COVID-19 Infection (VIRCO)

Bayside Health

Status and phase

Active, not recruiting

Phase 2

Conditions

COVID

Treatments

Drug: Favipiravir

Study type

Interventional

Funder types

Other

Identifiers

NCT04445467

66223

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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