The Prevent Severe COVID-19 (PRESECO) Study

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 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.