Status:
COMPLETED
Efficacy and Safety of Favipiravir in Management of COVID-19
Lead Sponsor:
Ain Shams University
Conditions:
Coronavirus Disease (COVID-19)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Randomized controlled interventional trial (Clinical Trial) phase 3 to assess the safety and efficacy of favipiravir versus the standard care therapy in the treatment of patients with COVID-19.
Detailed Description
Study Procedures: Screening phase: * Obtaining an informed consent * Written signed and dated informed consent will be obtained from each patient before being entered into the study. The investig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04349241
Start Date
April 18 2020
End Date
June 20 2020
Last Update
June 25 2020
Active Locations (1)
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1
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566