An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

Phase 2

• Conditions: COVID
• Interventions: Drug: Favipiravir

• Registration Number: NCT04445467
• Lead Sponsor: Bayside Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-07-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Favipiravir	Favipiravir	1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.
Placebo	Favipiravir	Matched Placebo

Primary Outcome Measures

Name	Time	Method
Time to virological cure	14 days	Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing

Secondary Outcome Measures

Name	Time	Method
Safety	28 days	All adverse events definitely, probably or possibly related to study treatment.
Clinical improvement	28 days	Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
Clinical symptoms	28 days	Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours
Biomarkers	28 days	Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.

Trial Locations

Locations (1)

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia