Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: DESREMTM
Injection Remdesivir, 100mg Lyophilized Powder: Route â?? Intravenous only
Dose â?? Day 1 started with 200 mg intravenous infusion over 30 to 120 minutes followed by Day 2,3,4, & 5 - maintenance dose
Sponsors
Mylan Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Admitted to a hospital and has confirmed Covid-19 infection (Moderate to Severe 2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures, understand and agrees to comply with planned study procedures 3. Male and non-pregnant female subjects aged 18 years and above 4. 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 5. Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare Directorate General of Health Services) Clinical Management Protocol COVID 19(Dated 03 Jul 2020): Clinical severity of moderate to severe. 6. 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 7. 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 DESREMTM 8. Any other condition as per the physicianâ??s discretion which would make the patient unsuitable for enrollment 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 |
|---|---|
| Percentage of patients with at least two-point improvement from baseline in clinical status on the 8-point Ordinal scale Mortality rateTimepoint: Day 14 Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Treatment Emergent AEsTimepoint: Day 1 to Day 28;Mean Change from BaselineTimepoint: Assessment day upto Day 28;Proportion of patients with viral clearance (SARS CoV-2 negativity)Timepoint: Day 7, Day 14/ Time of Discharge;Time to first fever normalizationTimepoint: Day 14 & Day 28;Time to RecoveryTimepoint: Day 14;Time to SpO2 94 % on room airTimepoint: Day 14 & Day 28 | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed