Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh
COVID-19, Favipiravir (Favipira)
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Age: Male or female patients 18 -65 years old
- Respiratory samples tested positive for the novel coronavirus.
- Initial symptoms will within 7 days
- Nonpregnant women (confirmed by urine human chorionic gonadotropin (HCG) test prior to enrollment)
Exclusion Criteria:
- Severe clinical condition (meeting one of the following criteria: a resting respiratory rate greater than 30 per minute, oxygen saturation below 93%, oxygenation index (OI) < 300 mmHg (1 mmHg = 133.3 Pa), respiratory failure, shock, and/or combined failure of other organs that required ICU monitoring and treatment).
Chronic liver and kidney disease and reaching end stage. (Serum aspartate aminotransferase (AST) and Serum alanine aminotransferase (ALT) will be elevated over 5 times of normal upper range will excluded).
(Normal upper limit of Serum AST = 40 units /L, ALT = 56 units /L)
- Serum uric acid >7.0 mg/dL in Male and Serum uric acid >6.0 mg/dL in Female will excluded
- ICU patient
- Previous history of allergic reactions to Favipiravir.
- Pregnant or lactating women
- Women of a childbearing age with a positive pregnancy test.
- Miscarriage, or within 2 weeks after delivery
- Hypertensive patients, who are taking Calcium Channel Blockers
Sites / Locations
- Mahanagar General Hospital, Dhaka (Site-1), Mugda Medical College Hospital, Dhaka (Site-2), Kurmitola General Hospital, Dhaka (Site-3), Dhaka Medical College Hospital, Dhaka (Site-4)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Favipiravir + Standard Treatment
Only Standard Treatment
Favipiravir 200 mg (Favipira) tablet will be given orally. Day 1: Tablet Favipiravir 1600 mg twice daily Days 2-Days 10: Tablet Favipiravir 600 mg twice daily.
Standard treatment included oxygen inhalation, oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs & the medication any patient is on due to any concomitant diseases.