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

Phase 4

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J98- Other respiratory disorders

• Registration Number: CTRI/2022/03/041252
• Lead Sponsor: CiplaLtd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.

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

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 <30ml/min).

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 < 24 hours prior to study drug dosing.

8. Participated in any other clinical trial or taken investigational drug within 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>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. <br/ ><br>All-cause mortality till day 28.

Secondary Outcome Measures

Name	Time	Method
Adverse events (Serious/Non-Serious, Expected/Unexpected, Related/Not Related) including infusion site reactions, abnormal clinically significant vital signs, physical examination or laboratory investigation. <br/ ><br>Time to clinical improvement. <br/ ><br>Proportion of subjects with viral clearance (RT-PCR negativity) at 7,14 days or at hospital discharge. <br/ ><br>Proportion of subjects with normalization of fever and oxygen saturation [criteria for normalization: temperature 36.6�°C armpit, 37.2�°C oral, 37.8�°C rectal; and SpO2 94%, sustained for at least 24 hours] through Day 14. <br/ ><br>Duration with and without mechanical ventilation <br/ ><br>Duration of oxygen use.Timepoint: At 7,14 days or at hospital discharge.