| CTRI Number |
CTRI/2021/06/034375 [Registered on: 24/06/2021] Trial Registered Prospectively |
| Last Modified On: |
12/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Observational study to check safety and effectiveness of CASIRIVIMAB/ IMDEVIMAB treatment of mild/moderate covid 19 patients in India |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Jeswani |
| Designation |
Consultant Physician and Intensivist |
| Affiliation |
Criticare Hospital and Research Institute |
| Address |
Criticare Hospital and Research Institute, Dhanshri Complex, 4th Floor, Humpyard Rd, near Hardeo Hotel, Sitabuldi
Nagpur
MAHARASHTRA
440012
India |
| Phone |
9823939000 |
| Fax |
|
| Email |
deepakjeswani2@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Viraj Suvarna |
| Designation |
Medical Chapter Lead |
| Affiliation |
Roche Products India Private Limited |
| Address |
146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Lal Bahadur Shastri Marg
Ghatkopar, Mumbai
Mumbai
MAHARASHTRA
400 086
India |
| Phone |
9820006317 |
| Fax |
|
| Email |
viraj.suvarna@roche.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Bhattacharya |
| Designation |
Lead - Clinical Operations |
| Affiliation |
Roche Products India Private Limited |
| Address |
146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg
Ghatkopar, Mumbai
Mumbai
MAHARASHTRA
400 086
India |
| Phone |
022-33941414 |
| Fax |
022-33941054 |
| Email |
priyanka.bhattacharya@roche.com |
|
|
Source of Monetary or Material Support
|
| Roche Products India Pvt Ltd
146-B, 166 A, Unit No. 7, 8, 98th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Roche Products India Pvt Ltd |
| Address |
146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Lal Bahadur Shastri Marg
Ghatkopar, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suneetha Narreddy |
Apollo Hospitals |
"Infectious Disease Specialist
9th floor, Apollo Tele Health Services, Apollo Health city, Lifesciences Building, Jubileehills, Hyderabad, Telangana 500033"
Hyderabad
TELANGANA |
9966022225
suneethanarreddy@hotmail.com |
| Dr Jayasree Krishnan |
Apollo Speciality Hospital |
"General Physician,
No. 64, off PH Road, Vanagaram to Ambattur Main Road, Ayanambakkam, Chennai - 600095, Tamil Nadu"
Chennai
TAMIL NADU |
9840411858
jayasree.krishnan@yahoo.co.in |
| Dr Deepak Jeswani |
Criticare Hospital and Research Institute |
"Consutant Physician and Intensivist
Dhanshri Complex, 4th Floor, Humpyard Rd, near Hardeo Hotel, Sitabuldi, Nagpur, Maharashtra 440012"
Nagpur
MAHARASHTRA |
9823939000
deepakjeswani2@yahoo.co.in |
| Dr Pruthu Narendra Dhekane |
Fortis Hospital |
Bannerghatta Road , Opposite IIM-B , Bengaluru ,Karnataka– 560076
Bangalore
KARNATAKA |
8983385463
pruthu.dhekane@fortishealthcare.com |
| Dr Rahul Pandit |
Fortis Hospital Limited |
"Director of Critical Care Medicine & ICU
Mulund Goregaon Link Rd, Nahur West, Bhandup West, Mumbai, Maharashtra 400078"
Mumbai
MAHARASHTRA |
9606047050
rahul.pandit@fortishealthcare.com |
| Dr Subramanian Swaminathan |
Gleneagles Global Health City |
Director- Infectious Diseases and Infection Control, 439, Embassy Residency Rd, Cheran Nagar, Perumbakkam, Chennai, Tamil Nadu 600100
Chennai
TAMIL NADU |
9789841925
drsubramanians@gmail.com |
| Dr Rajalakshmi A |
KIMSHEALTH |
Infectious Disease Consultant,
P.B.No.1, Anayara P.O, Trivandrum – 695029, Kerala, India
Thiruvananthapuram
KERALA |
9447151920
dr.a.rajalakshmi@gmail.com |
| Dr Ranganatha R |
Mazumdar Shaw Medical Center - A Unit of Narayana Health |
"Consultant, Department of Pulmonology
258/ A, Bommasandra Industrial Area, AnekalTaluk, Bangalore - 560099"
Bangalore
KARNATAKA |
9740200774
ranganatha.r.dr@narayanahealth.org |
| Dr Sushila Kataria |
Medanta -The Medicity |
Department of Internal Medicine, CH Baktawar Singh Rd, near Olympus, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001
Gurgaon
HARYANA |
9818828078
drsushilakataria@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Fortis Hospital Ethics Committee Fortis Hospital Ltd Bannerghatta Road Opp to IIM-B Bangalore |
Approved |
| Institutional Ethics Committee Fortis Hospitals Limited, Mumbai |
Approved |
| Institutional Ethics Committee Gleneagles Global Hospitals |
Approved |
| Institutional Ethics Committee of Mazumdar Shaw Medical Center - A Unit of Narayana Health |
Approved |
| Institutional Ethics Committee, Crticare Hospital and Research centre |
Approved |
| Institutional Ethics Committee-Clinical Studies Apollo Hospitals Enterprise Limited, Hyderabad Apollo Research and Innovations |
Approved |
| Institutional Ethics Committee-Clinical studies, Apollo Hopsitals Enterprise Ltd., Chennai |
Approved |
| Institutional Human Ethics Committee (IHEC) of KIMSHEALTH |
Approved |
| Medanta Institutional Ethics Committee Medanta-The Medicity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. confirmed covid-19 infection
2. Does not require oxygen
3. Symptoms are mil/moderate
4 At high risk for sever Covid 19 infection |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
the rate of Covid-19 related healthcare resource utilization including, but not limited
to emergency room visits, urgent care/unscheduled visits, and rehabilitation |
upto Day 90 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/07/2021 |
| Date of Study Completion (India) |
09/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
09/12/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable at this stage |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a non-interventional, single-arm, observational study with primary prospective
data collection (NIS PDC) and retrospective collection of prior medical/treatment history
data from medical records. Mild/moderate Covid-19 patients, who are prescribed
treatment with the neutralizing monoclonal antibody (casirivimab and imdevimab) as per
the Emergency Use Authorization in India will be followed up for safety and efficacy up
to Day 90. All treatment choices in this study will be at the discretion of the treating
physician according to local standard of care or best practice and are independent of
participation in this study. No additional laboratory or other diagnostic tests will be
performed on patients due to their participation in this study. No study-specific site visits
are mandated by the study protocol |