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

• ClinicalTrials.gov Identifier: NCT04445467
• Recruitment Status: Active, not recruiting
• First Posted: June 24, 2020
• Last Update Posted: October 7, 2021
• Sponsor: Bayside Health
• Information provided by (Responsible Party): Bayside Health

Tracking Information

• First Submitted Date: June 22, 2020
• First Posted Date: June 24, 2020
• Last Update Posted Date: October 7, 2021
• Actual Study Start Date: July 30, 2020
• Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 22, 2020)

Time to virological cure [ Time Frame: 14 days ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 22, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Adaptive Clinical Trial of Antivirals for COVID-19 Infection
• Official Title: An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: COVID

Intervention

Drug: Favipiravir

Favipiravir

Study Arms

• Experimental: Favipiravir
  1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.
  Intervention: Drug: Favipiravir
• Placebo Comparator: Placebo
  Matched Placebo
  Intervention: Drug: Favipiravir

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 22, 2020): 190
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT04445467
• Other Study ID Numbers: 66223
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Bayside Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Bayside Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bayside Health
• Verification Date: October 2021