Clinical trial NCT04474457: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Ministry of Health, Turkey
Sponsor class: OTHER_GOV
Collaborators: name: Hacettepe University
name: Prof. Dr. Cemil Tascıoglu City Hospital
name: Umraniye Education and Research Hospital
name: Istanbul Training and Research Hospital
name: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
name: Tepecik Training and Research Hospital
name: Istanbul University - Cerrahpasa
name: Ankara University
name: Ankara City Hospital Bilkent
name: Ankara Training and Research Hospital
name: Ege University Hospital (Application and Research Center)
name: Derince Training and Research Hospital
name: Istanbul University
name: Kayseri City Hospital
First posted: 2020-07-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 .

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.

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

Primary outcomes:
measure: Time to recovery (discharge)
timeFrame: 7 days
measure: Decrease in viral load
timeFrame: 7 days
Secondary outcomes:
measure: Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment
timeFrame: 7 days
measure: Frequency of occurrence of lymphopenia from baseline
timeFrame: 7 days
measure: Frequency of occurrence of thrombocytopenia from baseline
timeFrame: 7 days
measure: Changes in alanine aminotransferase (ALT) levels from baseline
timeFrame: 7 days
measure: Changes in aspartate aminotransferase (AST) levels from baseline
timeFrame: 7 days
measure: Changes in C-reactive protein (CRP) levels from baseline
timeFrame: 7 days
measure: Changes in level of D-dimer levels from baseline
timeFrame: 7 days
measure: Changes in prothrombin time (PT) values from baseline
timeFrame: 7 days
measure: Changes in partial thromboplastin time (PTT) values from baseline
timeFrame: 7 days
measure: Changes in blood pressure from baseline
timeFrame: 7 days
measure: Changes in respiratory rate from baseline
timeFrame: 7 days
measure: Changes in pulse oximetry from baseline
timeFrame: 7 days
measure: Changes in fever from baseline
timeFrame: 7 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, School of Medicine
Study officials:
References: