Health Condition 1: U071- COVID 19 virus identified
Conditions
Interventions
Intervention1: Favipiravir Film Coated Tablets 200mg & 800 mg: Day 1 dose: 800 mg (two tablets) + 200 mg (one tablet) twice on day 1 Followed by 800 mg one tablet twice daily till day 14.
Control Inte
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults with confirmed COVID 19 infection. 2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. Male or non-pregnant female adult 18 to 65 years of age at time of enrollment. 5. Duration of symptoms less than 7 days. 6. Screening ECG without clinically significant ECG abnormalities. 7. Has laboratory confirmed SARS CoV 2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following: i) PCR positive in sample collected less than 72 hours prior to Day 1; OR ii) PCR positive in sample collected more than or equal to 72 hours prior to Day 1, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking more than 24 hours, etc.) AND progressive disease suggestive of ongoing SARS CoV 2 infection. OR iii) Positive COVID-19 Antigen Test. 8. Illness of mild or moderate severity as defined below: Mild: i) Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache. AND ii) Without evidence of breathlessness (RR less than 24) or Hypoxia (Normal saturation SpO2 greater than 94 percent). 9. Moderate: i) Pneumonia with no signs of severe disease. ii) Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 in range 90 to 94 percent on room air and Respiratory Rate more or equal to 24 per minute. 10. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 28. Agrees to not participate in another clinical trial for the treatment of COVID 19 or SARS CoV 2 through Day 28.
Exclusion criteria
Exclusion criteria: 1. Patients with clinical signs of pneumonia plus one of the following: respiratory rate more than 30 breaths per min, severe respiratory distress, SpO2. 2. Requiring mechanical ventilation or ECMO at screening. 3. Estimated glomerular filtration rate (eGFR) less than 30 ml per min (including patients receiving hemodialysis or hemofiltration). 4. Pregnancy or breast feeding. 5. Evidence of multiorgan failure. 6. Allergy to any study medication. 7. Patients on medicinal products which are contraindicated to be used with any study medication. 8. Any malignancy or cerebro vascular complications. 9. Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment in the study. 10. Participated in any other clinical trial or taken investigational drug within 1 month. 11. 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. 12. AST/ALT more than 5.0 ULN or bilirubin more than 3.0 ULN. 13. Serum Uric Acid greater than 3.0 ULN or having symptoms of and being treated for active gout.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events up to day 28 in subjects receiving Favipiravir.Timepoint: Up to Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to Clinical Improvement Clinical Improvement defined as a. Normalization of pyrexia and body pain. b. Respiratory rate less than 24/minute. c. Relief from cough. Maintenance of above for more than 24 hours. 2. Percentage of subjects reporting each severity rating on an 8-point ordinal scale 3. Incidence and Duration (days) of oxygen use 4. Incidence and Duration (days) of mechanical ventilation. 5. Mortality. 6. Incidence of rescue medication use. 7. Frequency of serious adverse events.Timepoint: 1. at Day 15 2. at Day 5, 7 and 15 3. at Day 28 | — |
Countries
India
Contacts
Public ContactDr Ganesh H Divekar
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed