Favipiravir in High-risk COVID-19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Favipiravir in High Risk COVID-19 Patients: A Randomised, Open-label, Multicenter Clinical Trial

Conditions
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Covid19

Intervention / Treatment
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* Drug: Favipiravir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Favipiravir<br>Favipiravir treatment group (with standard of care), | Drug: Favipiravir<br>* Day 1: 1800mg BD, day 2-5: 800mg BD<br>|
| No Intervention: Control<br>No favipiravir given. Standard of care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for oxygen supplement | Drop in SPO2 in room air to <95% or requiring supplemental oxygen to maintain SPO2≥95% | Day of discharge/day 28 of treatment (if still hospitalized) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |