| CTRI Number |
CTRI/2021/10/037337 [Registered on: 14/10/2021] Trial Registered Prospectively |
| Last Modified On: |
05/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the effect of Covid Vaccine in patients living with HIV/AIDS in central Kerala and to identify different types of SARS CoV2 viruses affecting these patients |
|
Scientific Title of Study
|
Effectiveness of Covid Vaccine and identification of SARS CoV2 Variants among PLHIV in Central Kerala – An Ambi-directional Cohort Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joe Thomas |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute Thrissur |
| Address |
Dept of Community Medicine
Jubilee Mission Medical College and Research Institute
Thrissur
Kerala 680005
Thrissur
KERALA
680005
India |
| Phone |
9447960010 |
| Fax |
|
| Email |
covidjmmcri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Joe Thomas |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute Thrissur |
| Address |
Dept of Community Medicine
Jubilee Mission Medical College and Research Institute
Thrissur
Kerala 680005
Thrissur
KERALA
680005
India |
| Phone |
9447960010 |
| Fax |
|
| Email |
covidjmmcri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Joe Thomas |
| Designation |
Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute Thrissur |
| Address |
Dept of Community Medicine
Jubilee Mission Medical College and Research Institute
Thrissur
Kerala 680005
Dept of Community Medicine
Jubilee Mission Medical College and Research Institute
Thrissur
Kerala 680005
Thrissur
KERALA
680005
India |
| Phone |
9447960010 |
| Fax |
|
| Email |
covidjmmcri@gmail.com |
|
|
Source of Monetary or Material Support
|
| INdian Council of Medical Research(ICMR)
V Ramalingaswami Bhavan
PO Box No 4911
Ansari Nagar
New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V Ramalingaswamy Bhavan
PO box no 4911
Ansari nagar
New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Joe Thomas |
JubIee Mission Medical College and Research Institute |
Deptartment of Community Medicine
JubIee Mission Medical College and Research Institute
Thrissur
KERALA |
9447960010
covidjmmcri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jubilee Mission Medical College and Rsearch Institute Thrissur |
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, (2) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
PLHIV above 18 years of age |
|
| ExclusionCriteria |
| Details |
Any participant not able to communicate coherently or is non-ambulatory (mentally ill, dementic, bedridden, unconscious & comatose) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vaccine effectiveness of COVID-19 vaccines among PLHIV |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Cut off value of CD4 count that could predict severity of COVID-19 in PLHIV
2)Proportion of different SARS CoV-2 variants infecting PLHI
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="910"
Sample Size from India="910"
Final Enrollment numbers achieved (Total)= "925"
Final Enrollment numbers achieved (India)="925" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
in Process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PLHIV are at risk of adverse outcomes of SARS CoV-2 infection. Immune suppression, indicated by a low CD4 T-cell count (<200/µl) is found to be associated with risk for severe disease in PLHIV and COVID-19 vaccination evidently prevents severe disease. The assessment of real world effectiveness of these vaccines in PLHIV and determination of cut off value of CD4 count for severe COVID-19 and determining the genomic variants of SARS CoV 2 virus in PLHIV is imperative. Novelty: There is paucity of literature on effectiveness of COVID vaccine and estimates of cut off value of CD4 counts in PLHIV, which can determine their priority for vaccination. The study entails the identification of SARS CoV 2 variants in PLHIV. Objectives: a) To determine the real world effectiveness of COVID-19 vaccines in PLHIV b) To estimate the cut off of CD4 count level for severe Covid-19 and to study the variants of SARS CoV 2 virus in PLHIV Methods: Ambidirectional cohort study would be conducted among 910 PLHIV in the support groups of Thrissur and Palakkad districts, Kerala with a follow up of one year. Sociodemographic details, COVID infection and vaccination details, baseline CD4 count and NP swab for RT-PCR testing would be collected at enrollment and follow-up. Expected outcomes: a) Vaccine effectiveness of COVID-19 vaccines among PLHIV b) Cut off value of CD4 count that could predict severity of COVID-19 in PLHIV c) Proportion of different SARS CoV-2 variants infecting PLHI |