Efficacy and Safety of Favipiravir in Management of COVID-19 (FAV-001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04349241|
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : June 25, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Disease (COVID-19)||Drug: favipiravir Drug: Standard of care therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
A block-randomization scheme will be generated by computer software. 100 patients with confirmed COVID-19 will be randomized between favipiravir and the standard of care therapy (treated according to the national protocol) in a 1:1 ratio.
Group 1: 50 patients will receive the investigational drug favipiravir. Group 2: 50 patients will receive oseltamivir and hydroxychloroquine as the national standard of care therapy.
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Favipiravir in Management of COVID-19|
|Actual Study Start Date :||April 18, 2020|
|Actual Primary Completion Date :||June 1, 2020|
|Actual Study Completion Date :||June 20, 2020|
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
pyrazine carboxamide derivative (6-fluoro-3-hydroxy-2-pyrazinecarboxamide), a new type of RNA-dependent RNA polymerase (RdRp) inhibitor
Other Name: pyrazine carboxamide derivative
Active Comparator: Standard of care therapy
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.
Drug: Standard of care therapy
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
Other Name: National Egyptian guideline
- Viral clearance [ Time Frame: 14 days ]Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
- Clinical improvement [ Time Frame: 14 days ]Normal body temperature for 48 hours
- Radiological Improvement [ Time Frame: 14 days ]Improvement of radiological abnormalities at day 14
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349241
|Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center|
|Cairo, Non-US, Egypt, 11566|
|Principal Investigator:||Hany Dabbous||Ain Shams University|
|Responsible Party:||Hany Dabbous, Assistant professor of Faculty of Medicine, Ain Shams University|
|Other Study ID Numbers:||
FMASU P14 / 2020
|First Posted:||April 16, 2020 Key Record Dates|
|Last Update Posted:||June 25, 2020|
|Last Verified:||June 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases