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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Time to recovery (discharge)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who are pregnant or females who are breast feeding
- •Patients under the age of 15
研究组 & 干预措施
COVID-19/Favipiravir
Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with "Favipiravir".
干预措施: Favipiravir (Drug)
结局指标
主要结局
Time to recovery (discharge)
时间窗: 7 days
The evaluation of the recovery discharge until the 7th day of hospitalization after the initiation of treatment.
Decrease in viral load
时间窗: 7 days
The evaluation of decrease in viral load until 7th day hospitalization after the initiation of treatment.
次要结局
- Changes in C-reactive protein (CRP) levels from baseline(7 days)
- Frequency of occurrence of lymphopenia from baseline(7 days)
- Frequency of occurrence of thrombocytopenia from baseline(7 days)
- Changes in alanine aminotransferase (ALT) levels from baseline(7 days)
- Changes in aspartate aminotransferase (AST) levels from baseline(7 days)
- Adverse Event (AE), Serious Adverse Event (SAE) and discontinuation of treatment(7 days)
- Changes in fever from baseline(7 days)
- Changes in level of D-dimer levels from baseline(7 days)
- Changes in prothrombin time (PT) values from baseline(7 days)
- Changes in partial thromboplastin time (PTT) values from baseline(7 days)
- Changes in blood pressure from baseline(7 days)
- Changes in respiratory rate from baseline(7 days)
- Changes in pulse oximetry from baseline(7 days)
研究者
Prof. Ates KARA, MD
Prof.
Hacettepe University