Health Condition 1: J989- Respiratory disorder, unspecified
Conditions
Interventions
Intervention1: Injection Remdesivir 100mg (Lyophilized): Remdesivir is used to treat adults and children at least 28 days and older who weigh at least 7 pounds (3 kilograms) with positive results for
Sponsors
Syngene International Ltd
Syngene International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and non-pregnant, non-lactating females of aged >= 18 years. 2. Patients weighing >= 40Kg. 3. Willing and able to provide written informed consent or with a legally acceptable representative (LAR) who can provide informed consent. 4. Hospitalized with laboratory confirmed SARS-CoV-2 infection as determined by Positive RT-PCR test 5. Presence of at least one of the following: a. Tachypnoea (respiratory rate >= 24 breaths per minute). b. An SpO2 6. Male patients must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and upto the study completion visit. Patients must refrain from fathering a child in the next 2 weeks following the last study drug administration or have undergone vasectomy (vasectomy must have been done more than 6 months prior to first dosing). Contraceptive usage requirement will be conveyed during the informed consent process. Patients will be advised to follow effective method of contraception until 2 weeks after the last dose is given. Patient must agree to not donate sperm or blood while on study drug, for the entire duration of the study, and for 2 weeks after the last dose. 7. All women of childbearing potential (i.e., ovulating, pre-menopausal) should use at least 2 reliable forms of contraception during the trial, one of which must be a physical barrier method, as discussed with the study doctor and should agree to continue such precautions during the trial and for 2 weeks after receiving the last dose of the study drug. Female patients of childbearing potential must agree to get pregnancy test done at the time of enrollment and it should be negative. 8. Patients, in the opinion of investigator, willing to and able to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: History or evidence of hypersensitivity or allergy to Remdesivir or any of its excipients. 2 Patients with ALT >3 times the upper limit of normal (ULN) at baseline. 3 Patients with severe renal impairment (eGFR less than 30 mL/min) as calculated using Cockcroft-Gault formula. 4 Patients with known history of Hepatitis B, Hepatitis C or HIV infection. 5 Patients having any other serious illness which in the opinion of the investigator, precludes the participation of the patient in the study. 6 Breastfeeding females (feeding can be restarted one week after last dose of Remdesivir). 7 Patients who are participating in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 infection. Patients for whom, in the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 9 In the opinion of the investigator, participation in this study will not be in the best interest of the patient, or any other condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature and severity of adverse events causally related to Remdesivir.Timepoint: Total time points of 8(excluding screening) â?? Day 1-6, Day 14 and Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with recovery 2. Time to recovery (Recovery is defined as being in category 1, 2, or 3 in the 8-point ordinal scale) 3. Time to an Improvement of at Least Two Categories Using 8-point Ordinal Scale 4. Change in supplemental oxygen support requirement during the study 5. Time (days) to Discharge from Hospital 6. Proportion of patients Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use 7. Mortality by day 14 & day 28Timepoint: Total time points of 8(excluding screening) â?? Day 1-6, Day 14 and Day 28. | — |
Countries
India
Contacts
Public ContactDr Rajalakshmi M
Syngene International Limited
Outcome results
None listed