A clinical study to understand the effect of Remdesivir injection in hospitalized severe Covid-19 patients.

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 <= 93% on room air.

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method