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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445467
Recruitment Status : Active, not recruiting
First Posted : June 24, 2020
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Bayside Health

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date October 7, 2021
Actual Study Start Date  ICMJE July 30, 2020
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Adaptive Clinical Trial of Antivirals for COVID-19 Infection
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE Drug: Favipiravir
Favipiravir
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 22, 2020)
190
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04445467
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bayside Health
Study Sponsor  ICMJE Bayside Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bayside Health
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP