Efficacy and Safety of Favipiravir in Management of COVID-19
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Clinical improvement
Study Overview
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:
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Obtaining an informed consent
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Written signed and dated informed consent will be obtained from each patient before being entered into the study. The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial. This will be obtained from each subject in accordance with the recommendation of the revised Declaration of Helsinki. The investigator will explain the nature, purpose and risks of the study. It will be clearly stated that the patient is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.
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In case the patient is unable to provide his/her consent the legal guardian will give verbal approval on behaves of the patient and after he he/she will be well informed by the study design, procedure, risk and benefits over phone call.
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If it is difficult to reach the legal guardian, emergency approval will be obtained by Professional Legal Representative who will be the head authorities of the isolation hospital.
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Full medical history, concurrent medications, demographic data will be obtained.
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A thorough physical examination will be performed.
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Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and Blood oxygen saturation) will be recorded.
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Chest X-ray or CT chest will be recorded.
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Laboratory to perform the following tests:
Complete blood count with differential counts, COVID -19 PCR test by nasopharyngeal swab. C-reactive protein and serum ferritin level. Renal function tests (RFTs) (serum creatinine), Liver function tests (LFTs) (alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin), Coagulation test; prothrombin time and INR. HIV antibody, HCV antibody and HBV surface antigen (HBsAg). Urine pregnancy test for females.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
favipiravir
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
Intervention: favipiravir (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.
Intervention: Standard of care therapy (Drug)
Outcomes
Primary Outcomes
Clinical improvement
Time Frame: 14 days
Normal body temperature for 48 hours
Viral clearance
Time Frame: 14 days
Two successive negative COVID-19 PCR analysis tests 48-72 hours apart
Secondary Outcomes
- Radiological Improvement(14 days)
Investigators
Hany Dabbous
Assistant professor of Faculty of Medicine
Ain Shams University