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

Sponsor
Bayside Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04445467
Collaborator
(none)
190
Enrollment
1
Location
2
Arms
16.1
Anticipated Duration (Months)
11.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection
Actual Study Start Date :
Jul 30, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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
Placebo Comparator: Placebo

Matched Placebo

Drug: Favipiravir
Favipiravir

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Safety [28 days]

    All adverse events definitely, probably or possibly related to study treatment.

  2. Clinical improvement [28 days]

    Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale

  3. 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

  4. Biomarkers [28 days]

    Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alfred Health Melbourne Victoria Australia 3004

Sponsors and Collaborators

  • Bayside Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayside Health
ClinicalTrials.gov Identifier:
NCT04445467
Other Study ID Numbers:
  • 66223
First Posted:
Jun 24, 2020
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Favipiravir

Study Results

No Results Posted as of Oct 7, 2021