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

January 29, 2021 updated by: Prof. Ates KARA, MD, Ministry of Health, Turkey

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 days
Decrease in viral load
Time Frame: 7 days
The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
7 days
Frequency of occurrence of lymphopenia from baseline
Time Frame: 7 days
Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.
7 days
Frequency of occurrence of thrombocytopenia from baseline
Time Frame: 7 days
Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.
7 days
Changes in alanine aminotransferase (ALT) levels from baseline
Time Frame: 7 days
Clinical evaluation of ALT levels from baseline until the end of study.
7 days
Changes in aspartate aminotransferase (AST) levels from baseline
Time Frame: 7 days
Clinical evaluation of AST levels from baseline until the end of study.
7 days
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.
7 days
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.
7 days
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.
7 days
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.
7 days
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.
7 days
Changes in respiratory rate from baseline
Time Frame: 7 days
Clinical evaluation of respiratory rate levels from baseline until the end of study.
7 days
Changes in pulse oximetry from baseline
Time Frame: 7 days
Clinical evaluation of pulse oximetry levels from baseline until the end of study.
7 days
Changes in fever from baseline
Time Frame: 7 days
Clinical evaluation of changes in fever from baseline until the end of study.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Health, Turkey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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