A clinical study on Favipiravir in mild to moderate COVID-19 patients

Phase 4

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/11/029263
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of favipiravir prescribed in treatment of patients with mild to moderate COVID-19 disease in India. <br/ ><br>1. Number of AEs <br/ ><br>2. Number of SAEs <br/ ><br>3. Number of treatment related AEs and SAEs as assessed by the treating physician <br/ ><br>4. Number of AEs leading to dose modification/ discontinuation of treatmentTimepoint: Upto 28 days

Secondary Outcome Measures

Name	Time	Method
1. Time to clinical cure <br/ ><br>Defined as resolution of baseline clinical signs and symptoms of COVID-19 infection based on clinical assessment by the investigator. <br/ ><br>2. Rate of clinical cure. <br/ ><br>3. Time to resolution of Pyrexia <br/ ><br>4. Percentage of patients requiring AOT/NIV/MV/ECMO support. <br/ ><br>5. Time to hospital discharge for hospitalized patients. <br/ ><br>6. All-cause mortality rate.Timepoint: 1. Upto 14 days <br/ ><br>2. At Day 7 and 14 <br/ ><br>3. Upto 14 days <br/ ><br>4. At Day 7 and 14 <br/ ><br>5. Upto 14 days <br/ ><br>6. At Day 7, 14 and 28