Favipiravir in High-risk COVID-19 Patients

Penang Hospital, Malaysia

Status and phase

Completed

Phase 3

Conditions

Covid19

Treatments

Drug: Favipiravir

Study type

Interventional

Funder types

Other

Identifiers

NCT04818320

Favirpiravir-A1

Details and patient eligibility

About

The study aims to investigate the efficacy of favipiravir in high-risk COVID-19 patients. The study population includes symptomatic mild-to-moderate COVID-19 inpatients, within first 7 days of illness, who are 50 years old and above, and have 1 or more comorbidities. The study is designed as a randomised, open-label, multicenter clinical trial where the patients are randomised 1:1 to groups receiving favipiravir (5 days) versus no favipiravir.

Enrollment

500 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients are eligible to be included in the study only if they fulfil ALL the following criteria:
RT-PCR confirmed COVID-19 cases
Aged 50 years and above, AND have one or more co-morbidities
Within the first 7 days of illness (from symptom onset)
Mild to moderate clinical severity

Exclusion criteria

Asymptomatic stage 1 patients
Patients with SpO2 less than 95% without oxygen therapy
Patients who needs oxygen supplements
Patients with concomitant bacterial or fungal infection (confirmed by culture) prior to initiation of study
Patients with congestive heart failure
Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
Impaired kidney function (creatinine clearance according to Cockcroft-Gault formula less than 30 ml/min) at the time of screening.
Malabsorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
Pregnant or nursing women or women planning pregnancy.
Female patients who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of favipiravir administration to 7 days after the end of favipiravir administration
Male patients whose partner cannot agree to use the contraception method described in (9)
Patients with a history of gout or on treatment for gout or hyperuricemia
Patients receiving immunosuppressants
Patients who received interferon or drugs with reported antiviral activity against COVID-19 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination) within 7 days of illness.
Patients in whom this episode of infection is a recurrence or reinfection of COVID-19 infection
Patients who have previously received favipiravir
Patients who are not able to provide written consent by themselves
Other patients judged ineligible by the principal investigator or sub-investigator