The evaluation of efficacy of Favipiravir in patients with mild to moderate COVID-19

Phase 3

Recruiting

• Conditions: COVID-19; COVID-19.; U07.1

• Registration Number: IRCT20201005048936N1
• Lead Sponsor: Dr. Abidi pharmacutical Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 126

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
Any disease or disorder that investigators believed might put participants in an excess risk, if they were included
or history of allergy to any antiviral nocleoside-analog drugs with viral RNA polymerase inhibition mechanism
Active HBV, HCV
HIV or any other known immunological disorders or using immunosuppressive drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Turning PCR test result into negative. Timepoint: The 6th day and the 14th day after the intervention commence. Method of measurement: Laboratory PCR test for diagnosis of COVID-19.;Time to recovery of symptoms(fever and cough). Timepoint: up to 14 days after the intervention commence. Method of measurement: telephone call examination.;Symptoms recovery(fever and cough). Timepoint: day 6, day 14 and day 28 after the intervention commence. Method of measurement: telephone call examination.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and adverse reactions. Timepoint: up to the 28th day of follow up. Method of measurement: telephone call examination and/or lab tests.;ICU admission. Timepoint: up to 28 days after the commence of the intervention. Method of measurement: telephone call follow up.;Mortality. Timepoint: up to 28 days after the commence of the intervention. Method of measurement: telephone calls follow up.