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| Name | Class |
|---|---|
| Hacettepe University | OTHER |
| Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization | OTHER |
| Umraniye Education and Research Hospital | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19/Favipiravir | Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir | Drug | Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir". |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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 .
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University, School of Medicine | Ankara | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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| Istanbul Training and Research Hospital |
| OTHER_GOV |
| Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey | OTHER |
| Tepecik Training and Research Hospital | OTHER |
| Istanbul University - Cerrahpasa | OTHER |
| Ankara University | OTHER |
| Ankara City Hospital Bilkent | OTHER |
| Ankara Training and Research Hospital | OTHER |
| Ege University Hospital (Application and Research Center) | UNKNOWN |
| Derince Training and Research Hospital | OTHER |
| Istanbul University | OTHER |
| Kayseri City Hospital | OTHER_GOV |
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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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |