Status:
COMPLETED
Favipiravir in High-risk COVID-19 Patients
Lead Sponsor:
Penang Hospital, Malaysia
Collaborating Sponsors:
Enche' Besar Hajjah Khalsom Hospital
Jasin Hospital
Conditions:
Covid19
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04818320
Start Date
February 16 2021
End Date
July 13 2021
Last Update
November 24 2021
Active Locations (1)
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1
Penang General Hospital
George Town, Pulau Pinang, Malaysia, 10450