COVID
Conditions
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.
Interventions
DRUGFavipiravir
Favipiravir
Sponsors
Bayside Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 5 days * COVID-19 related symptom initiation within 5 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to virological cure | 14 days | Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 28 days | All adverse events definitely, probably or possibly related to study treatment. |
| Clinical improvement | 28 days | Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale |
| Clinical symptoms | 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 | 28 days | Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH. |
Countries
Australia
Outcome results
None listed