Comparison of the safety and efficacy of Favipiravir and kaletra in COVID-19

Phase 3

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

• Registration Number: IRCT20200318046812N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
Requiring hospitalization because of: Patient's oxygen saturation less than 93% OR
Requiring hospitalization because of: GCS score less than 15 OR
Requiring hospitalization because of: systolic blood pressure less than 100 or 30 mmHg decrease in systolic blood pressure from the level prior to current illness OR
Requiring hospitalization because of: renal failure (creatinine 1.5 times the previous measurement in the last 7 days OR
Requiring hospitalization because of: liver failure (AST and ALT 3 times upper limit of normal)
Patient's age between 16 and 100 years
Signed informed consent form.

Exclusion Criteria

Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir, ...)
Chronic liver failure
Chronic Renal Failure
Patients with acute problems whose survival is expected to be less than 48 hours
HIV patients
A history of gastrointestinal bleeding
Pregnancy and lactation
QT interval exceeds 500 ms

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Admission to intensive care unit. Timepoint: Once (when admitted to intensive care unit). Method of measurement: Hospital records.