Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Favipiravir 200 mg oral tablets: 1800 mg twice daily on Day 1 and 800 mg twice daily from Day 2
upto maximum 14 days along with supportive care
Control Intervention1: Supportive care a
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
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 6. Subjects within 7 days from symptom onset or within 48 hours of laboratory diagnosis of SARS-CoV2.
Exclusion criteria
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 3. Subjects with oxygen saturation (SPO2) partial pressure (PaO2)/ fraction of inspired O2 (FiO2) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to negativity in RT-PCR nucleic acid test. [defined as the presence of two consecutive negative results with RT-PCR detection over an interval of 24 hour]Timepoint: Up to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to clinical recovery(clinical recovery:normalization of pyrexia,respiratory rate and SPO2 and relief of cough that is maintained for at least 72 hours).Incidence of deterioration/aggravation of pneumonia.Time from randomization to resolution of pyrexia.Time from randomization to relief of cough.Time from randomization to relief of dyspnoea.Time to discharge from hospital.ICU admission rate. Adverse events(Serious/Non-serious,Expected/Unexpected,Related/Not Related)Timepoint: Up to 28 days. Till discharge/death whichever is earlier (up to Day 28) | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Ltd
Outcome results
None listed