Efficacy and Safety of Favipiravir in Management of COVID-19 (FAV-001)
Coronavirus Disease (COVID-19)
About this trial
This is an interventional treatment trial for Coronavirus Disease (COVID-19)
Eligibility Criteria
Inclusion Criteria:
Patients aged between 18 and 80 years.
Patients with confirmed COVID-19 documented by a diagnostic laboratory test (e.g., nasopharyngeal swab) at the time of illness.
And Have mild to moderate symptoms according to the national protocol classification of patients.
Exclusion Criteria:
Patients have severe or immediately life-threatening COVID-19, Severe disease is defined as: dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
Pregnant or lactating females.
Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
Sites / Locations
- Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
favipiravir
Standard of care therapy
favipiravir in a regimen of 3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10
oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10.