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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Drug: Favipiravir

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1000 patients aged 15 years or older and diagnosed with COVID-19 who meet inclusion/exclusion criteria of the study and have decision of treatment with favipiravir .

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19/Favipiravir; Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".	Drug: Favipiravir; Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recovery (discharge)	The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.	7 days
Decrease in viral load	The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Frequency of occurrence of lymphopenia from baseline	Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.	7 days
Frequency of occurrence of thrombocytopenia from baseline	Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.	7 days
Changes in alanine aminotransferase (ALT) levels from baseline	Clinical evaluation of ALT levels from baseline until the end of study.	7 days
Changes in aspartate aminotransferase (AST) levels from baseline	Clinical evaluation of AST levels from baseline until the end of study.	7 days
Changes in C-reactive protein (CRP) levels from baseline	Clinical evaluation of CRP levels from baseline until the end of study.	7 days
Changes in level of D-dimer levels from baseline	Clinical evaluation of D-dimer levels from baseline until the end of study.	7 days
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
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
Changes in blood pressure from baseline	Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.	7 days
Changes in respiratory rate from baseline	Clinical evaluation of respiratory rate levels from baseline until the end of study.	7 days
Changes in pulse oximetry from baseline	Clinical evaluation of pulse oximetry levels from baseline until the end of study.	7 days
Changes in fever from baseline	Clinical evaluation of changes in fever from baseline until the end of study.	7 days

Collaborators and Investigators

• Sponsor: Ministry of Health, Turkey
• Collaborators: Istanbul University; Ankara Training and Research Hospital; Istanbul Training and Research Hospital; Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey; Ankara City Hospital Bilkent; Tepecik Training and Research Hospital; Ankara University; Derince Training and Research Hospital; Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine; Ege University Hospital (Application and Research Center); Kayseri City Hospital; Hacettepe University, School of Medicine; Prof. Dr. Cemil Tascıoglu City Hospital; Umraniye Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Favipiravir
• Other Study ID Numbers: COVID-19-PMS-FAV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No