Prospective, Open label, Multicentre, Single Arm, Post Marketing study for evaluation of safety and efficacy of Favipiravir in Adult Indian Patients with Mild to Moderate COVID-19 disease
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 14
- 主要终点
- To evaluate the safety of favipiravir prescribed in treatment of patients with mild to moderate COVID-19 disease in India.
研究概览
简要总结
This is a prospective, open label, multicenter, single arm, post marketing study for evaluation of safety and efficacy ofFavipiravir in Adult Indian Patients with Mild to Moderate COVID-19 disease. Primary objective of the study is to evaluate safety and secondary objective is to evaluate efficacy of Favipiravir in mild to moderate cases of COVID-19. 1200 adult patients will be enrolled in the study. The anticipated maximum total study duration foreach patient is approximately 30 days (maximum) which includes screening of up to 2 days, enrolment of 1 day, actualtreatment period as per treating physician’s prescription (up to 14 daysmaximum), and an on-site/centre follow-up visit/telephonic follow-up aftercompletion of treatment which would be a routine follow up visit per normalclinical practice.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 18 years and above with mild to moderate COVID-
- •Patients who receive a prescription of favipiravir according to the indication stated in the approved prescribing information in India
- •Pyrexia (defined as axillary temperature more than or equal to 99 F or oral temperature more than or equal to 100 F) AND at least one of the following: Cough, fatigue, dyspnoea, expectoration, myalgia, rhinorrhoea, sore throat, diarrhoea, new loss of taste or smell, myalgia, headache or fatigue on admission.
- •Respiratory rate less than or equal to 30/min.
- •SpO2 more than or equal to 90% on room air.
- •Agree to follow effective contraceptive methods during and for 7 days after the end of the treatment with favipiravir for male and female patients in the reproductive age group.
- •For female patients of child-bearing age: evidence of negative pre-treatment urine pregnancy test
- •Voluntarily participating in the study; fully understanding and being fully informed of the study and having signed written Informed Consent Form (ICF).
排除标准
- •Refusal to participation expressed by patient or legally authorized representative.
- •Requiring NIV, Mechanical Ventilation or ECMO at baseline.
- •Severe hepatic or renal impairment
- •Pregnant or lactating women.
- •History of known hypersensitivity to Favipiravir.
- •Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure)
- •Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation.
- •Any other COVID-19 antiviral treatment.
结局指标
主要结局
To evaluate the safety of favipiravir prescribed in treatment of patients with mild to moderate COVID-19 disease in India.
时间窗: Upto 28 days
3. Number of treatment related AEs and SAEs as assessed by the treating physician
时间窗: Upto 28 days
1. Number of AEs
时间窗: Upto 28 days
2. Number of SAEs
时间窗: Upto 28 days
4. Number of AEs leading to dose modification/ discontinuation of treatment
时间窗: Upto 28 days
次要结局
- 1. Time to clinical cure(Defined as resolution of baseline clinical signs and symptoms of COVID-19 infection based on clinical assessment by the investigator.)