Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: DESREM LQ TM Remdesivir Injection 100mg/20 mL: Route – Intravenous only
Dose – Day 1 started with 200 mg intravenous infusion over 30 to 120 minutes followed by Day 2,3,4, & 5 - mainten
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 years of age at time of enrollment 5. 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: • PCR positive in sample collected • PCR positive in sample collected = 72 hours prior to enrollment, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection 6. Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare, Government of India) Clinical Guidance For Management of Adult COVID-19 Patients (Dated 22 Apr 2021): Clinical severity of moderate to severe. 7. 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 8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or any other indications through Day 28
Exclusion criteria
Exclusion criteria: 1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 3 times the upper limit of normal 2. Estimated glomerular filtration rate (eGFR) 3. Pregnancy or breast feeding 4. Subjects with 5. Subjects who are on mechanical ventilation or ECMO (Extracorporeal membrane oxygenation) 6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours 7. Hypersensitivity to any ingredient of DESREM LQTM 8. Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment in the study 9. Patients who are on or would require any other investigational therapies/products for the treatment of Covid-19 disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent AEs and SAEsTimepoint: Day 1 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality Percentage of patients with atleast Two point improvement from baseline in clinical status on the 8 Point ordinal scale Time to Recovery Time to SpO2 94 % on room air Time to first fever normalization Timepoint: Day 28 Day 14 Day 14 Day 14 Day 14 | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed