Status:
UNKNOWN
Study on Safety and Efficacy of Favipiravir (Favipira) for COVID-19 Patient in Selected Hospitals of Bangladesh
Lead Sponsor:
Bangladesh Medical Research Council (BMRC)
Conditions:
COVID-19
Favipiravir (Favipira)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
A recent outbreak of coronavirus disease 2019 (COVID-19) caused by the novel coronavirus designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in Wuhan, China, at the end ...
Detailed Description
•Rationale: Coronavirus disease 2019 (COVID-19) is defined as illness caused by a novel coronavirus now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; formerly called 2019-nCoV), ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04402203
Start Date
May 1 2020
End Date
July 1 2020
Last Update
May 26 2020
Active Locations (1)
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1
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)
Dhaka, Bangladesh