Intervention: Favipiravir
Trial phase: Phase 3
ATC code: J05AX27
SMILES: NC(=O)c1nc(F)cnc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 599
Group description: Favipiravir 200mg tablet

Favipiravir: Favipiravir
Eligibility criteria:
Inclusion Criteria:

Adults age 18 or older
Tested positive for SARS-CoV-2 by RT-PCR assay using a respiratory tract sample (either nasopharyngeal swab OR oropharyngeal swab OR nasal aspirate OR tracheobronchial aspirate OR saliva) collected within 72 hours of randomization
Stated willingness to give their written informed consent to participate in the study
Stated willingness to comply with all study procedures and availability for the duration of the study
Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to contraceptive measures during the study and for 7 days following the last dose of study medication
Females must be unable to bear children, OR ensure that their male partner is incapable of fathering a child, OR, if of childbearing potential will strictly adhere to contraceptive measures during the study and for seven days following the last dose of study medication
Females must agree to stop breast-feeding prior to first dose of study drug and through seven days after completing therapy
Females must have a negative pregnancy test at screening
Ability to take oral medication and be willing to adhere to the favipiravir/placebo regimen
Subject has access to a smart phone, tablet, or PC
Minimal baseline severity score for COVID-19-related symptoms: at least two symptoms with a score of 2 or higher. COVID-19-related symptoms (excluding changes in the sense of taste or smell) include:
stuffy or runny nose
sore throat
shortness of breath
cough
lack of energy or tiredness
muscle or body aches
headache
chills or shivering
feeling hot or feverish
nausea
diarrhea
vomiting

Exclusion Criteria:

O2 saturation <94%
Shortness of breath at rest
Heart rate ≥ 125 per minute
COVID-19 symptoms first presented >5 days prior to randomization
Requirement for hospitalization at the time of enrollment
Participation in another trial or use of any experimental treatment for COVID-19
Treatment with high steroid dose i.e. >30 mg/day prednisolone equivalent (excluding stable chronic treatment) or remdesivir or anyone receiving SARS-CoV-2 monoclonal antibodies within 3 months prior to enrollment
Known sepsis or organ dysfunction/ failure
Known infection with a respiratory virus other than SARS-CoV2 (e.g. Influenza) or any known bacterial infection (affecting the respiratory system or any other system)
Inability to adhere to study requirements
For premenopausal women: unwilling or unable to use effective birth control measures
Known allergy to favipiravir
Known end-stage kidney disease or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Known liver impairment greater than Child-Pugh A
Psychiatric illness that is not well controlled (defined as stable on a regimen for more than one year).
Known elevated uric acid levels in the past year or taking uric acid lowering medications (allopurinol, febuxostat)
History of hereditary xanthinuria or history of xanthine urolithiasis.
History of gout or actively being treated for gout.
Current use of the following medications, which cannot be discontinued for the duration of the study: pyrazinamide, hydralazine, more than 3000 mg of acetaminophen per day.