Official Title
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
Brief 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.

Unknown status
COVID-19

Drug: Favipiravir

Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".

Eligibility Criteria

Inclusion Criteria:

- Male and female patients, diagnosed with Covid-19 disease who are 15 years of age or
older at the time of enrollment

- Patients who have understood all study procedures that will be applied under the study
protocol

- Patients with confirmed diagnosis of COVID-19 by PCR and/or other accepted methods and
have a treatment decision with favipiravir

- Patients who will accept oropharyngeal sample and venous blood sample collection
periodically within the scope of the study protocol

Exclusion Criteria:

- Patients who are pregnant or females who are breast feeding

- Patients under the age of 15

Eligibility Gender
All
Eligibility Age
Minimum: 15 Years ~ Maximum: N/A
Countries
Turkey
Locations

Hacettepe University, School of Medicine
Ankara, Turkey

Ministry of Health, Turkey
NCT Number
MeSH Terms
COVID-19
Favipiravir