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. 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 : Recruiting
First Posted : June 24, 2020
Last Update Posted : September 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID||Drug: Favipiravir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.
Placebo Comparator: Placebo
- 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
- 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.
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
|Contact: James McMahonfirstname.lastname@example.org|
|Contact: Janine Roneyemail@example.com|
|Melbourne, Victoria, Australia, 3004|
|Contact: James McMahon +61390766908 firstname.lastname@example.org|