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

• ClinicalTrials.gov Identifier: NCT04474457
• Recruitment Status: Unknown
• First Posted: July 16, 2020
• Last Update Posted: February 1, 2021
• Sponsor: Ministry of Health, Turkey
• Collaborators: Hacettepe University, School of Medicine; Prof. Dr. Cemil Tascıoglu City Hospital; Umraniye Training and Research Hospital; Istanbul Training and Research Hospital; Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey; Tepecik Training and Research Hospital; Istanbul University - Cerrahpasa (IUC); Ankara University; Ankara City Hospital Bilkent; Ankara Training and Research Hospital; Ege University Hospital (Application and Research Center); Derince Training and Research Hospital; Istanbul University; Kayseri City Hospital
• Information provided by (Responsible Party): Prof. Ates KARA, MD, Hacettepe University

Tracking Information

• First Submitted Date: July 15, 2020
• First Posted Date: July 16, 2020
• Last Update Posted Date: February 1, 2021
• Actual Study Start Date: June 11, 2020
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 15, 2020)

• Time to recovery (discharge) [ Time Frame: 7 days ]
  The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.
• Decrease in viral load [ Time Frame: 7 days ]
  The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 15, 2020)

• Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment [ Time Frame: 7 days ]
  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.
• Frequency of occurrence of lymphopenia from baseline [ Time Frame: 7 days ]
  Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.
• Frequency of occurrence of thrombocytopenia from baseline [ Time Frame: 7 days ]
  Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.
• Changes in alanine aminotransferase (ALT) levels from baseline [ Time Frame: 7 days ]
  Clinical evaluation of ALT levels from baseline until the end of study.
• Changes in aspartate aminotransferase (AST) levels from baseline [ Time Frame: 7 days ]
  Clinical evaluation of AST levels from baseline until the end of study.
• Changes in C-reactive protein (CRP) levels from baseline [ Time Frame: 7 days ]
  Clinical evaluation of CRP levels from baseline until the end of study.
• Changes in level of D-dimer levels from baseline [ Time Frame: 7 days ]
  Clinical evaluation of D-dimer levels from baseline until the end of study.
• Changes in prothrombin time (PT) values from baseline [ Time Frame: 7 days ]
  Clinical evaluation of PT values for blood to coagulate from baseline until the end of study.
• Changes in partial thromboplastin time (PTT) values from baseline [ Time Frame: 7 days ]
  Clinical evaluation of PTT values for blood to coagulate from baseline until the end of study.
• Changes in blood pressure from baseline [ Time Frame: 7 days ]
  Clinical evaluation of systolic and diastolic blood pressure levels from baseline until the end of study.
• Changes in respiratory rate from baseline [ Time Frame: 7 days ]
  Clinical evaluation of respiratory rate levels from baseline until the end of study.
• Changes in pulse oximetry from baseline [ Time Frame: 7 days ]
  Clinical evaluation of pulse oximetry levels from baseline until the end of study.
• Changes in fever from baseline [ Time Frame: 7 days ]
  Clinical evaluation of changes in fever from baseline until the end of study.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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 .
• Condition: COVID-19

Intervention

Drug: Favipiravir

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

Study Groups/Cohorts

COVID-19/Favipiravir

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

Intervention: Drug: Favipiravir

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 15, 2020): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2021
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04474457
• Other Study ID Numbers: COVID-19-PMS-FAV
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Ates KARA, MD, Hacettepe University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ministry of Health, Turkey
• Original Study Sponsor: Same as current

Collaborators

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

• Investigators: Not Provided
• PRS Account: Ministry of Health, Turkey
• Verification Date: January 2021