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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04474457
• Other study ID #: COVID-19-PMS-FAV
• Status: Active, not recruiting
• Start date: June 11, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2021
• Source: Ministry of Health, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University, School of Medicine	Ankara

Sponsors (15)

Lead Sponsor

Collaborator

Ministry of Health, Turkey

Ankara City Hospital Bilkent, Ankara Training and Research Hospital, Ankara University, Derince Training and Research Hospital, Ege University Hospital (Application and Research Center), Hacettepe University, School of Medicine, Istanbul Training and Research Hospital, Istanbul University, Istanbul Faculty of Medicine, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Kayseri City Hospital, Prof. Dr. Cemil Tascioglu City Hospital, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey, Tepecik Training and Research Hospital, Umraniye Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery (discharge)	The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.	7 days
Primary	Decrease in viral load	The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.	7 days
Secondary	Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment	Number/characteristics of Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment due to study drug from baseline until the end of study.	7 days
Secondary	Frequency of occurrence of lymphopenia from baseline	Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.	7 days
Secondary	Frequency of occurrence of thrombocytopenia from baseline	Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.	7 days
Secondary	Changes in alanine aminotransferase (ALT) levels from baseline	Clinical evaluation of ALT levels from baseline until the end of study.	7 days
Secondary	Changes in aspartate aminotransferase (AST) levels from baseline	Clinical evaluation of AST levels from baseline until the end of study.	7 days
Secondary	Changes in C-reactive protein (CRP) levels from baseline	Clinical evaluation of CRP levels from baseline until the end of study.	7 days
Secondary	Changes in level of D-dimer levels from baseline	Clinical evaluation of D-dimer levels from baseline until the end of study.	7 days
Secondary	Changes in prothrombin time (PT) values from baseline	Clinical evaluation of PT values for blood to coagulate from baseline until the end of study.	7 days
Secondary	Changes in partial thromboplastin time (PTT) values from baseline	Clinical evaluation of PTT values for blood to coagulate from baseline until the end of study.	7 days
Secondary	Changes in blood pressure from baseline	Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.	7 days
Secondary	Changes in respiratory rate from baseline	Clinical evaluation of respiratory rate levels from baseline until the end of study.	7 days
Secondary	Changes in pulse oximetry from baseline	Clinical evaluation of pulse oximetry levels from baseline until the end of study.	7 days
Secondary	Changes in fever from baseline	Clinical evaluation of changes in fever from baseline until the end of study.	7 days