An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection (VIRCO)
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|ClinicalTrials.gov Identifier: NCT04445467|
Recruitment Status : Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
|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|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
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|