| CTRI Number |
CTRI/2020/11/029141 [Registered on: 16/11/2020] Trial Registered Prospectively |
| Last Modified On: |
12/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Sero-surveillance for Dengue, Chikungunya and COVID |
|
Scientific Title of Study
|
Establish serial sero-surveillance to monitor the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population, India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Dixit |
| Designation |
Senior Program Officer |
| Affiliation |
The INCLEN Trust International |
| Address |
THE INCLEN TRUST INTERNATIONAL, F-1/5, SECOND FLOOR, OKHLA INDUSTRIAL AREA PHASE 1.
South
DELHI
110020
India |
| Phone |
9810618897 |
| Fax |
|
| Email |
shikha.dixit@inclentrust.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Nair |
| Designation |
Program Officer |
| Affiliation |
The INCLEN Trust International |
| Address |
THE INCLEN TRUST INTERNATIONAL, F-1/5, SECOND FLOOR, OKHLA INDUSTRIAL AREA PHASE 1.
South
DELHI
110020
India |
| Phone |
8056748342 |
| Fax |
|
| Email |
divya.nair@inclentrust.org |
|
Details of Contact Person
Public Query
|
| Name |
Divya Nair |
| Designation |
Program Officer |
| Affiliation |
The INCLEN Trust International |
| Address |
THE INCLEN TRUST INTERNATIONAL, F-1/5, SECOND FLOOR, OKHLA INDUSTRIAL AREA PHASE 1.
South
DELHI
110020
India |
| Phone |
8056748342 |
| Fax |
|
| Email |
divya.nair@inclentrust.org |
|
|
Source of Monetary or Material Support
|
| National Biopharma Mission (NBM), Biotechnology Industry Research Advisory Council (BIRAC) |
|
|
Primary Sponsor
|
| Name |
Shikha Dixit |
| Address |
THE INCLEN TRUST INTERNATIONAL, F-1/5, SECOND FLOOR, OKHLA INDUSTRIAL AREA PHASE 1. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shikha Dixit |
The INCLEN Trust International |
The INCLEN Trust International, F-1/5, 2nd Floor, Okhla Industrial Area Phase - 1, New Delhi
South
DELHI |
9810618897
shikha.dixit@inclentrust.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The INCLEN Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals asymtomatic of COVID-19 /ILI symptoms / all individuals currently residing and likely to stay till the end of study (1 year) in the study area |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Survey will be carried out in individuals above 2 years of age (no upper limit on age) and all individuals currently residing and likely to stay till the end of study (1 year) in the study area will be considered eligible for inclusion. |
|
| ExclusionCriteria |
| Details |
Individuals who are unlikely to stay in the study area for the next 1 year |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objectives
I. Estimate the sero-prevalence of SARS-CoV-2 infection in the general population
II. Estimate the 4 monthly incidence of SARS-CoV-2 infection based on serial sero-surveys
III. Estimate cumulative sero-conversion of SARS-CoV-2 infection over one year period
IV. Estimate the sero-prevalence and annual sero conversion of Dengue and Chikungunya in a sub sample of the study |
Sero-prevalence of COVID will be assessed at baseline, 4 months, 8 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objectives
I. Monitor the trend of SARS-CoV-2 transmission in the general population
II. Determine the prevalence and incidence of SARS CoV2 sero-positivity among the members of the households with at least one seropositive individual (clustering of infection at household level) Determine the risk factors for SARS-CoV-2 infection
III. Determine the duration of persistence of antibodies in individuals tested positive for SARS-CoV-2 infection
|
Trend of infection and duration of persistence of antibodies will be monitored by the serial sero-surveys at 0,4,8 and 12 months.
Incidence of symptomatic infections will be assessed via fortnightly phone calls. |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As part of the clinical trial network being set up by National Biopharma Mission (NBM)- Biotechnology Industry Research Assistance Council (BIRAC), four existing demographc surveillance sites (also referred to as Demographic Health Surveillance sites-DHS)/Health and Demographic Surveillance Sites-HDSS) /Demographic, Developmental and Environmental Surveillance Sites-DDESS) were selected to study epidemiology of Dengue & Chikungunya in different age-groups. In view of the COVID-19 pandemic, these sites with established community presence and experience of maintaining population cohorts is being leveraged to fill knowledge gaps related to the actual burden of COVID disease in the community as well as to improve understanding of the community transmission dynamics. A fifth site from Pune district of Maharashtra was added for COVID specific research objectives to ensure representation from the Western part of the country. Study sites are as following; A. Society for Health Allied Research Education India (SHARE INDIA), Medchal, Telangana B. Christian Medical College, Vellore C. ICMR-National Institute of Epidemiology- Model Rural Health Research Unit, Tirunelveli D. SOMAARTH-DDESS, The INCLEN Trust International, Palwal, Haryana E. Vadu HDSS, KEM Hospital Research Centre (KEMHRC), Pune It is proposed to establish community-based sentinel sero-surveillance to monitor the transmission of SARS-CoV-2 infection in selected demographic health surveillance sites in India. The study will be conducted in both urban and rural communities. Five sites shall follow same protocol under supervision of Principal Investigator at each site. Overall, 25,000 participants will be enrolled with each site enrolling 5000 participants. Serials sero survey will be done at 4 month intervals for SARS-COV2 (Month 0,4,8,12). Additionally, a serial sero survey will be done at 12 month interval for Dengue and chikungunya (month 0& 12) in a subset of 1500 sample. Below mentioned is the study design; Prospective follow up of a cohort of individuals within specified geographical locations. The key groups of activities entailed in follow up would be A. Serial sero-surveys at 4 monthly intervals for SARS-CoV2 (Month 0,4,8,12) B. Serial sero-survey at 12 month interval for Dengue and Chikungunya (months 0 & 12) in a subset of the sample C. Syndromic acute febrile illness/Influenza like illness surveillance through fortnightly phone calls |