A study of Favipiravir in patients with mild to moderate coronavirus disease (COVID-19)

Phase 3

Suspended

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

• Registration Number: CTRI/2020/06/025799
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. A voluntarily given written signed dated informed consent from subjects and/or legally acceptable representative.

2. Subjects of either gender and age between 18 and 75 years.

3. Confirmed diagnosis of mild to moderate COVID-19. (positivity in RTPCR

2019-nCoV test on respiratory tract specimens).

4. In case of moderate COVID-19, subjects with CT or Chest X-ray

documented pneumonia.

5. Subjects with pyrexia (axillary >=37â?? or oral >=37.5â??, or rectal>=38â??)

or either respiratory rate >24/min and <30/min or cough.

6. Subjects within 7 days from symptom onset or within 48 hours of

laboratory diagnosis of SARS-CoV2.

Exclusion Criteria

1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care.

2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min).

3. Subjects with oxygen saturation (SPO2) <=90% or arterial oxygen

partial pressure (PaO2)/ fraction of inspired O2 (FiO2) <=300 mmHg.

4. Refractory nausea, vomiting, or chronic gastrointestinal disorders,

inability to swallow the study drug or having undergone extensive

bowel resection which may affect adequate absorption of Favipiravir.

5. Subjects with gout or hyperuricemia.

6. Pregnant or breast-feeding subjects.

7. Subject is using adrenocorticosteroids (except topical or inhaled

preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).

8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.

9. Subject has a history of alcohol or drug abuse in the previous 6 months.

10. Subject has a psychiatric disease that is not well controlled where

controlled is defined as: stable on a regimen for more than one year.

11. Subject already treated with another COVID 19 therapy but has

relapsed with a positive diagnosis.

12. Anticipated transfer to another hospital which is not a study site

within 72 hours.

13. Participated in any other clinical trial or taken investigational drug

within 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified