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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474457
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : July 20, 2020
Sponsor:
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, Cerrahpasa Faculty of Medicine
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, Istanbul Faculty of Medicine
Kayseri City Hospital
Information provided by (Responsible Party):
Prof. Ates KARA, MD, Hacettepe University

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.

Condition or disease Intervention/treatment
COVID-19 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

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".




Primary Outcome Measures :
  1. 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.

  2. Decrease in viral load [ Time Frame: 7 days ]
    The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.


Secondary Outcome Measures :
  1. 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.

  2. Frequency of occurrence of lymphopenia from baseline [ Time Frame: 7 days ]
    Clinical evaluation of occurrence of lymphopenia from baseline until the end of study.

  3. Frequency of occurrence of thrombocytopenia from baseline [ Time Frame: 7 days ]
    Clinical evaluation of occurrence of thrombocytopenia from baseline until the end of study.

  4. Changes in alanine aminotransferase (ALT) levels from baseline [ Time Frame: 7 days ]
    Clinical evaluation of ALT levels from baseline until the end of study.

  5. Changes in aspartate aminotransferase (AST) levels from baseline [ Time Frame: 7 days ]
    Clinical evaluation of AST levels from baseline until the end of study.

  6. 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. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Changes in respiratory rate from baseline [ Time Frame: 7 days ]
    Clinical evaluation of respiratory rate levels from baseline until the end of study.

  12. Changes in pulse oximetry from baseline [ Time Frame: 7 days ]
    Clinical evaluation of pulse oximetry levels from baseline until the end of study.

  13. Changes in fever from baseline [ Time Frame: 7 days ]
    Clinical evaluation of changes in fever from baseline until the end of study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474457


Contacts
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Contact: Prof. Ateş KARA, MD +90 532 4135130 ateskara@hacettepe.edu.tr

Locations
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Turkey
Hacettepe University, School of Medicine Recruiting
Ankara, Turkey
Contact: Prof. Ateş KARA, MD    +90 532 4135130    ateskara@hacettepe.edu.tr   
Sponsors and Collaborators
Ministry of Health, Turkey
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, Cerrahpasa Faculty of Medicine
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, Istanbul Faculty of Medicine
Kayseri City Hospital
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Responsible Party: Prof. Ates KARA, MD, Prof., Hacettepe University
ClinicalTrials.gov Identifier: NCT04474457    
Other Study ID Numbers: COVID-19-PMS-FAV
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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