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

Non-Interventional Observational Study Assessing Safety And Efficacy Of Neutralizing Monoclonal Antibody (Casirivimab/ Imdevimab) Treatment In A Real-World-Setting Of Mild/Moderate Covid-19 Patients In India

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/06/034375

Enrollment

200

Registered

2021-06-24

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
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 oxygenTimepoint: 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.	—

Measure

Time frame

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 oxygenTimepoint: 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.

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Secondary

Measure	Time frame
the rate of Covid-19 related healthcare resource utilization including, but not limited to emergency room visits, urgent care/unscheduled visits, and rehabilitationTimepoint: upto Day 90	—

Countries

India

Contacts

Public ContactPriyanka Bhattacharya

Roche Products India Private Limited

viraj.suvarna@roche.com9820006317

Outcome results