NCT04474457

Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age

An ObservationaI Study to Evaluate the Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age Who Are Receiving Favipiravir

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Ministry of Health, Turkey · Other Government
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.

Detailed description

The clinical picture of 2019-nCoV disease is in a broad spectrum, which includes asymptomatic infection, a mild upper respiratory tract infection, respiratory failure, and even severe viral pneumonia with death. Although the mortality rate is not yet clear, the reported case-fatality risk was 11-14% during the initial studies which included patients with severe disease. The overall case fatality rate was reported as approximately 2%. In addition, most cases have resulted in a pneumonia requiring supplemental oxygen therapy and ventilator support. The alarming levels of spread and severity of COVID-19 caused a global emergency and this outbreak has been characterized as a pandemic by the World Health Organization (WHO). Studies have suggested that investigational product favipiravir can improve the recovery of patients with mild disease and reduce the treatment duration from less than 11 days. The main purpose of this study is to obtain efficacy and safety data for favipiravir use in the Turkish patient cohort diagnosed with COVID-19 and decided to be treated with "Favipiravir" before enrollment to this observational study. This study is designed as an observational drug study which will evaluate the safety and efficacy of favipiravir in patients and diagnosed with COVID-19 and older than 15 years of age. This study is designed as an observational drug study to evaluate the safety and efficacy of favipiravir in patients diagnosed with COVID-19 and older than 15 years of age with a favipiravir treatment decision. Patients who have already had a routine favipiravir treatment decision or favipiravir treatment started will be included in this study. A total of 1000 female and male patients aged 15 years or older will be included in the study. The planned observation duration for each patient is 7 days. This study will be conducted in 14 sites.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Favipiravir	Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".

Timeline

• Start date: 2020-06-11
• Primary completion: 2020-12-31
• Completion: 2021-06-01
• First posted: 2020-07-16
• Last updated: 2021-02-01

Locations

1 site across 1 country: Turkey (Türkiye)