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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favipiravir | Experimental | 1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days. |
|
| Placebo | Placebo Comparator | Matched Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir | Drug | Favipiravir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to virological cure | Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | All adverse events definitely, probably or possibly related to study treatment. | 28 days |
| Clinical improvement | Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. | |
| 33050947 |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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| 28 days |
| Clinical symptoms | 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 | 28 days |
| Biomarkers | Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH. | 28 days |
| McMahon JH, Lau JSY, Roney J, Rogers BA, Trubiano J, Sasadeusz J, Molton JS, Gardiner B, Lee SJ, Hoy JF, Cheng A, Peleg AY. An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 13;21(1):847. doi: 10.1186/s13063-020-04766-5. |