We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
COVID Drug: Favipiravir Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : July 30, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety [ Time Frame: 28 days ]
    All adverse events definitely, probably or possibly related to study treatment.

  2. 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

  3. 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

  4. Biomarkers [ Time Frame: 28 days ]
    Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445467


Locations
Layout table for location information
Australia, Victoria
Alfred Health
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT04445467    
Other Study ID Numbers: 66223
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Favipiravir
Antiviral Agents
Anti-Infective Agents