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Clinical Trial Evaluating the Efficacy and Safety of Favipiravir in Moderate to Severe COVID-19 Patients

NCT04529499 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2022-03-21

Study results available
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Summary

This is a prospective, interventional, multi-centre, phase III, randomized, double blind, placebo-controlled, parallel design trial to evaluate the efficacy, safety and tolerability of favipiravir as adjunct ('add on') to supportive care, in comparison to placebo with supportive care, in the acute treatment of patients who have tested positive for SARS-CoV-2 and presenting with moderate to severe COVID-19.

This study will be conducted in two parts; Stage I - Main study and Stage II - Extended Follow up.

Conditions

  • Covid19

Interventions

DRUG

AVIGAN

Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio

DRUG

Placebo Comparator

Patients will be randomized to the placebo + supportive care group in a 1:1 ratio

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Sagar Munjal, MD, MS · Dr Reddy's Laboratories, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-22
Primary Completion
2021-01-22
Completion
2021-01-27
FDA Drug
Yes

Countries

  • Kuwait

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529499 on ClinicalTrials.gov