Favipiravir in High-risk COVID-19 Patients
- Registration Number
- NCT04818320
- Lead Sponsor
- Penang Hospital, Malaysia
- 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, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Favipiravir Favipiravir Favipiravir treatment group (with standard of care),
- Primary Outcome Measures
Name Time Method Need for oxygen supplement Day of discharge/day 28 of treatment (if still hospitalized) Drop in SPO2 in room air to \<95% or requiring supplemental oxygen to maintain SPO2≥95%
- Secondary Outcome Measures
Name Time Method Difference in the number of patients admitted to ICU Day of discharge/day 28 of treatment (if still hospitalized) Difference in the number of patients requiring mechanical ventilation Day of discharge/day 28 of treatment (if still hospitalized) Changes in the length of ICU stay Day of discharge/day 28 of treatment (if still hospitalized) Changes in in-hospital mortality rate Day of discharge/day 28 of treatment (if still hospitalized)
Trial Locations
- Locations (1)
Penang General Hospital
🇲🇾George Town, Pulau Pinang, Malaysia