An Observational study to check safety and effectiveness of CASIRIVIMAB/ IMDEVIMAB treatment of mild/moderate covid 19 patients in India

Not Applicable

Completed

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

• Registration Number: CTRI/2021/06/034375
• Lead Sponsor: Roche Products India Pvt Ltd

Brief Summary

This is a non-interventional, single-arm, observational study with primary prospectivedata collection (NIS PDC) and retrospective collection of prior medical/treatment historydata from medical records. Mild/moderate Covid-19 patients, who are prescribedtreatment with the neutralizing monoclonal antibody (casirivimab and imdevimab) as perthe Emergency Use Authorization in India will be followed up for safety and efficacy upto Day 90. All treatment choices in this study will be at the discretion of the treatingphysician according to local standard of care or best practice and are independent ofparticipation in this study. No additional laboratory or other diagnostic tests will beperformed on patients due to their participation in this study. No study-specific site visitsare mandated by the study protocol

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Study Completion: 2021-09-12
• Last Update Posted: 2022-12-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• confirmed covid-19 infection 2.
• Does not require oxygen 3.
• Symptoms are mil/moderate 4 At high risk for sever Covid 19 infection.

Exclusion Criteria

• hospitalized due to COVID-19 2.
• Require oxygen therapy due to Covid-19 3.
• Require an increase in baseline oxygen flow rate due to Covid-19.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The purpose of this study is to assess the real-world safety and efficacy of neutralizing monoclonal antibody (casirivimab/imdevimab) treatment in mild/moderate COVID-19 patients in India, who are at high risk of severe COVID-19 and do not require oxygen	The neutralizing antibody will be administered at the baseline visit (Day 0). Visits 1, 2, 3 and 4 will be conducted by phone, at days 7, 14, 28 and 90. Data Collected during Observational Period.

Secondary Outcome Measures

Name	Time	Method
the rate of Covid-19 related healthcare resource utilization including, but not limited	to emergency room visits, urgent care/unscheduled visits, and rehabilitation

Trial Locations

Locations (9)

Apollo Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Apollo Speciality Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Criticare Hospital and Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

Fortis Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Fortis Hospital Limited; 🇮🇳 Mumbai, MAHARASHTRA, India

Gleneagles Global Health City; 🇮🇳 Chennai, TAMIL NADU, India

KIMSHEALTH; 🇮🇳 Thiruvananthapuram, KERALA, India

Mazumdar Shaw Medical Center - A Unit of Narayana Health; 🇮🇳 Bangalore, KARNATAKA, India

Medanta -The Medicity; 🇮🇳 Gurgaon, HARYANA, India

Apollo Hospitals

🇮🇳Hyderabad, TELANGANA, India

Dr Suneetha Narreddy

Principal investigator

9966022225

suneethanarreddy@hotmail.com