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

Primary Purpose

COVID

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Favipiravir
Sponsored by
Bayside Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alfred Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Favipiravir

Placebo

Arm Description

1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.

Matched Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2020
Last Updated
October 6, 2021
Sponsor
Bayside Health
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1. Study Identification

Unique Protocol Identification Number
NCT04445467
Brief Title
An Adaptive Clinical Trial of Antivirals for COVID-19 Infection
Acronym
VIRCO
Official Title
An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Favipiravir
Arm Type
Experimental
Arm Description
1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched Placebo
Intervention Type
Drug
Intervention Name(s)
Favipiravir
Intervention Description
Favipiravir
Primary Outcome Measure Information:
Title
Time to virological cure
Description
Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety
Description
All adverse events definitely, probably or possibly related to study treatment.
Time Frame
28 days
Title
Clinical improvement
Description
Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
Time Frame
28 days
Title
Clinical symptoms
Description
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
Time Frame
28 days
Title
Biomarkers
Description
Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34473343
Citation
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.
Results Reference
derived
PubMed Identifier
33050947
Citation
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.
Results Reference
derived

Learn more about this trial

An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

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