IRCT20201005048936N1
Recruiting
Phase 3
The evaluation of safety and efficacy of Favipiravir (ABIDI Pharmaceutical Co, Iran) to shorten the contagiousness in patients with mild to moderate COVID-19
Dr. Abidi pharmacutical Co.0 sites126 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr. Abidi pharmacutical Co.
- Enrollment
- 126
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with mild to moderate COVID\-19 symptoms (According to the national guidance definitions) with positive PCR test for COVID\-19
- •At least 18 years old
- •Less than 10 days from the onset of symptoms
Exclusion Criteria
- •History of liver disorders (specifically active liver disorders and liver dysfunction included: ALT/AST \> 1\.5 ULN and ALP \> 2\.5 ULN and total Bilirubin\>1\.25 ULN)
- •Allergy to Favipiravir or its ingredients
- •Pregnancy and lactation
- •History of gastrointestinal(GI) disorders such as GI bleeding or GI inflammatory diseases or history of GI surgery that intervene in the Favipiravir absorption process
- •History of active or latent tuberculosis
- •Active infection other than COVID\-19
- •Abnormal metabolism of uric acid/ Gout
- •Abnormal test results in the screening stage that need more clinical assessments
- •Participation in any type of clinical trials in the last 30 days
- •Any psychological disorders that affects patient compliance of the study protocol
Outcomes
Primary Outcomes
Not specified
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