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

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1. Adult patients aged 18 years and above with mild to moderate COVID-19.
•2. Patients who receive a prescription of favipiravir according to the indication stated in the approved prescribing information in India
•3. 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.
•4. Respiratory rate less than or equal to 30/min.
•5. SpO2 more than or equal to 90% on room air.
•6. 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.
•7. For female patients of child-bearing age: evidence of negative pre-treatment urine pregnancy test
•8. Voluntarily participating in the study; fully understanding and being fully informed of the study and having signed written Informed Consent Form (ICF). Also if a pregnancy is reported, consent should be given for follow up of pregnancy until outcome.

•1. Refusal to participation expressed by patient or legally authorized representative.
•2. Requiring NIV, Mechanical Ventilation or ECMO at baseline.
•3. Severe hepatic or renal impairment
•4. Pregnant or lactating women.
•5. History of known hypersensitivity to Favipiravir.
•6. Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure)
•7. 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.
•8. Any other COVID-19 antiviral treatment.

发起方

Glenmark Pharmaceuticals Ltd