| CTRI Number |
CTRI/2020/07/026759 [Registered on: 23/07/2020] Trial Registered Prospectively |
| Last Modified On: |
21/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Detection of Antibodies to COVID-19 |
|
Scientific Title of Study
|
Evaluation and Validation of the clinical performance of VITROS Anti SARS COV2 Total assay in the COVID-19 patient population and commercialization of the Assay on VITROS 3600 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smita Sarma |
| Designation |
Associate Director |
| Affiliation |
Medanta- The Medicity |
| Address |
Department of Laboratory Medicine, Medanta- The Medicity, Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9868723089 |
| Fax |
|
| Email |
smita.sarma@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Sarma |
| Designation |
Associate Director |
| Affiliation |
Medanta- The Medicity |
| Address |
Department of Laboratory Medicine, Medanta- The Medicity, Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9868723089 |
| Fax |
|
| Email |
smita.sarma@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Sarma |
| Designation |
Associate Director |
| Affiliation |
Medanta- The Medicity |
| Address |
Department of Laboratory Medicine, Medanta- The Medicity, Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9868723089 |
| Fax |
|
| Email |
smita.sarma@medanta.org |
|
|
Source of Monetary or Material Support
|
| Ortho Clinical Diagnostics
Unit Plot No 810, ILD Trade Centre, Sector-47,
Sohna Road, Subhash Chowk, Gurugram-122001 |
|
|
Primary Sponsor
|
| Name |
Ortho Clinical Diagnostics |
| Address |
Unit Plot No 810
ILD Trade Center
Sector 47
Sohna Road
Subhas Chowk
Gurgaon 122001 |
| Type of Sponsor |
Other [Diagnostic Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Sarma |
Medanta The medicity |
Department of Labarotory Medicine
Division of Clinical Microbiology and Infection prevention and Control
Upper Ground Floor
Medanta- The Medicity
Sector-38, Gurugram 122001
Haryana
Gurgaon
HARYANA |
9868723089
smita.sarma@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed using VITROS® CoV2T assay in VITROS® 3600 or 5600 systems.
Asymptomatic health care professionals, will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System.
Samples from normal healthy adult asymptomatic individuals (collected before Nov., 2019) will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System. |
|
| ExclusionCriteria |
| Details |
Exclude samples from patients for whom the time between symptom onset and collection of samples cannot be determined.
Exclude grossly hemolyzed, icteric or turbid samples, or samples with visible particulates that are not getting removed even after centrifugation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identifying individuals with an adaptive immune response to SARS-CoV-2 infection. |
Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed. Titres at 8th day will be considered as baseline data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the positive percent agreement (PPA) of the serological assay in comparison with the
currently in use RT PCR assay
To evaluate the PPA of the serological assay in symptomatic patients of Covid-19 (SARS CoV2
RT PCR Positive), when the sample was collected post 8 days from the onset of symptoms.
|
Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The data generated will help in:
Identifying individuals with an adaptive immune response to SARS-CoV-2 infection.
To evaluate the positive percent agreement (PPA) of the serological assay in comparison with the currently in use RT PCR assay
To evaluate the PPA of the serological assay in symptomatic patients of Covid-19 (SARS CoV2 RT PCR Positive), when the sample was collected post 8 days from the onset of symptoms. |