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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID
• Intervention / Treatment: Drug: Favipiravir

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matched Placebo	Drug: Favipiravir; Favipiravir
Experimental: Favipiravir; 1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.	Drug: Favipiravir; Favipiravir

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	All adverse events definitely, probably or possibly related to study treatment.	28 days
Clinical improvement	Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale	28 days
Clinical symptoms	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	28 days
Biomarkers	Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.	28 days

Collaborators and Investigators

• Sponsor: Bayside Health

Publications and helpful links

General Publications

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
• McMahon JH, Lau JSY, Roney J, Rogers BA, Trubiano J, Sasadeusz J, Molton JS, Gardiner B, Lee SJ, Hoy JF, Cheng A, Peleg AY. An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 13;21(1):847. doi: 10.1186/s13063-020-04766-5.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Favipiravir
• Other Study ID Numbers: 66223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No