Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J98- Other respiratory disorders
Conditions
Interventions
Intervention1: Remdesivir: The dose of the drug for adult subjects weighing more than 40 kg should be a single dose of 200 mg infused intravenously over 30 to 120 minutes on day 1 followed by once-dai
Sponsors
CiplaLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1. A voluntarily given informed consent from subjects and/or legally acceptable representative (in case subject is not conscious and oriented). 2. Subjects of either gender and age between 18 and 65 years. 3. Subjects who are hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and moderate to severe disease. Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 Severe COVID-19: Severe pneumonia with clinical signs of pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air.
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergy or hypersensitivity to Remdesivir or any of its components. 2. Subjects with Chronic liver disease (ALT/AST >5ULN) and chronic renal disease (GFR 3. Pregnant or breastfeeding subjects. 4. Any serious medical condition or evidence of multiorgan failure or abnormality of clinical laboratory tests that, investigators judgment, precludes the subjects in the subject safe participation in and completion of the study. 5. Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. 6. Anticipated transfer to another hospital which is not a study site within 72 hours. 7. Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 8. Participated in any other clinical trial or taken investigational drug within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with clinical improvement (defined as an improvement of at least 2 points from baseline on the WHO-8-point ordinal scale) through Day 14. All-cause mortality till day 28.Timepoint: Proportion of subjects with clinical improvement (defined as an improvement of at least 2 points from baseline on the WHO-8-point ordinal scale) through Day 14. All-cause mortality till day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (Serious/Non-Serious, Expected/Unexpected, Related/Not Related) including infusion site reactions, abnormal clinically significant vital signs, physical examination or laboratory investigation. Time to clinical improvement. Proportion of subjects with viral clearance (RT-PCR negativity) at 7,14 days or at hospital discharge. Proportion of subjects with normalization of fever and oxygen saturation [criteria for normalization: temperature 36.6Ã?°C armpit, 37.2Ã?°C oral, 37.8Ã?°C rectal; and SpO2 94%, sustained for at least 24 hours] through Day 14. Duration with and without mechanical ventilation Duration of oxygen use.Timepoint: At 7,14 days or at hospital discharge. | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Ltd
Outcome results
None listed