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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
190
Favipiravir
Alfred Health
Melbourne, Victoria, Australia
Time to virological cure
Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
Time frame: 14 days
Safety
All adverse events definitely, probably or possibly related to study treatment.
Time frame: 28 days
Clinical improvement
Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
Time frame: 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
Time frame: 28 days
Biomarkers
Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.
Time frame: 28 days
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