A Study to Assess the Safety and Efficacy of Remdesivir in COVID-19 infected Indian patients

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2021/12/039011
• Lead Sponsor: Jubilant Generics Limited

Brief Summary

COVID-19 is a respiratory illness that has led to a pandemic affecting more than 200 countries in the world. It is caused by SARS-CoV2 virus, which is member of Beta Corona-virus family and has a significant genomic homology to SARS and MERS viruses. It is caused by SARS-CoV2 virus, which is member of Beta Corona-virus family and has a significant genomic homology to SARS and MERS viruses.

Remdesivir is authorized for use for treatment of patients hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and moderate to severe disease Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.

As per the definition of MoHFW guidelines:

Moderate disease is defined as patients with presence of clinical features pneumonia with 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 disease is defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-15
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• 1.Age -18 years and above (no upper age limit) 2.Patients admitted in hospital with a proven diagnosis of moderate to severe COVID 19 infection.
• 3.Patients with moderate disease defined as patients with presence of clinical features pneumonia with dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute.
• 4.Patients with severe disease defined as patients with clinical signs of pneumonia with respiratory rate >30 breaths/min or severe respiratory distress or SpO2 <90% on room air.

Exclusion Criteria

• Exclusion Criteria: 1.Known hypersensitivity or idiosyncratic reaction to Remdesivir, its excipients or similar classes of drugs.
• 2.Inability of subject or legally authorized representative to provide written informed consent.
• 3.Patients with <40 kg body weight 4.eGFR less than 30 mL per minute 5.Pregnant or nursing women 6.Patients with ALT/AST ≥ 5 times the upper limit of normal at baseline 7.Evidence of multiorgan failure 8.Mechanically ventilated (including Veno-Venous ECMO) ≥ 5 days, or any duration of Veno-Arterial ECMO 9.Exposed to other investigational drugs within 30 day of first administration of Remdesivir.
• 10.Unsuitable for the study in the opinion of the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
4.Mortality rate at Day 28	28 days of follow up
2.Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.	28 days of follow up
3.Percentage of subjects with improvement of at least 2 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28]	28 days of follow up
1.Time to recovery [ Time Frame: Day 1 through Day 28]	28 days of follow up

Secondary Outcome Measures

Name	Time	Method
1.Percentage of subjects with improvement of at least 1 point in clinical status using ordinal scale [Time Frame: Day 1 through Day 28]	2.Proportion of subjects with viral clearance (SARS CoV-2 negativity) at Day 7 and Day 14 or at hospital discharge (whichever is earlier)

Trial Locations

Locations (4)

Aster MIMS hospital; 🇮🇳 Ernakulam, KERALA, India

Citizen hospital; 🇮🇳 Bangalore, KARNATAKA, India

Krishna Institute of Medical Sciences Deemed to be University; 🇮🇳 Satara, MAHARASHTRA, India

Nil Ratan Sircar Medical college and hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Aster MIMS hospital

🇮🇳Ernakulam, KERALA, India

Dr Jabir M P

Principal investigator

91-6235707744

jabir.zubair@gmail.com