Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Adaptive Randomised Placebo Controlled Phase II 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445467
Recruitment Status : Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bayside Health

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

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

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




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.



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 12 days
  • COVID-19 related symptom initiation within 12 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

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


Contacts
Layout table for location contacts
Contact: James McMahon +61390766908 james.mcmahon@monash.edu
Contact: Janine Roney +61390766908 gaclinresearch@alfred.org.au

Sponsors and Collaborators
Bayside Health
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: June 24, 2020
Last Verified: June 2020
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
Infection