Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 9:10 AM
Study NCT ID:
NCT04474457
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age
Sponsor:
Ministry of Health, Turkey
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: