A study to evaluate the usefulness and side effects of injection Remdesivir in moderate to severe covid 19 lung affected patients in a multispeciality hospital in Kolkata.

Not Applicable

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 3: B338- Other specified viral diseasesHealth Condition 4: J168- Pneumonia due to other specified infectious organisms

• Registration Number: CTRI/2021/02/031541
• Lead Sponsor: nil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-30
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 63

Inclusion Criteria

1.Age =18 years at time of signing Informed Consent Form

2.Laboratory (RT-PCR) confirmed COVID-19.

3.Lung involvement confirmed with chest imaging

4.Hospitalized with a SaO2/SPO2=94% on room air or Pa02/Fi02 ratio <300mgHg

5.=12 days since illness onset

6.Have given consent to participate in the study.

Exclusion Criteria

1.Severe liver disease (e.g. Child Pugh score = C, AST >5 times upper limit)

2.Pregnant or breastfeeding, or positive pregnancy test in a pre dose examination

3.Patients with known severe renal impairment (estimated glomerular filtration rate =30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis

4.Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ] <br/ ><br>Defined as the time (in days) from starting of study treatment (Remdesivir) along with the standard of care until a decline of two categories on a Six category ordinal scale of clinical status (1 ? discharged; 6 ? death) or live discharge from hospital. <br/ ><br> <br/ ><br>Timepoint: 1.Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ] <br/ ><br>Defined as the time (in days) from starting of study treatment (Remdesivir) along with the standard of care until a decline of two categories on a Six category ordinal scale of clinical status (1 ? discharged; 6 ? death) or live discharge from hospital. <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Clinical status, assessed (days 7, 14, 21, and 28). <br/ ><br>2.Time to hospital discharge or NEWS2 (National Early Warning Score 2) of = 2 maintained for 24 hours. <br/ ><br>3.All cause mortality Duration (days) of mechanical ventilation Duration (days) of supplemental oxygenation Length of hospital stay (days) <br/ ><br>4.Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens <br/ ><br>5.Frequency of serious adverse drug events [ All Time Frame: up to 28 days ] <br/ ><br>Timepoint: up to 28 days from starting study drugs.