Sero-surveillance for Dengue, Chikungunya and COVID

Not yet recruiting

Conditions: 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

Registration Number: CTRI/2020/11/029141

Lead Sponsor: Shikha Dixit

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 5000

Inclusion Criteria

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.

Exclusion Criteria

Individuals who are unlikely to stay in the study area for the next 1 year.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objectives	Sero-prevalence of COVID will be assessed at baseline, 4 months, 8 months and 12 months
I. Estimate the sero-prevalence of SARS-CoV-2 infection in the general population	Sero-prevalence of COVID will be assessed at baseline, 4 months, 8 months and 12 months
II. Estimate the 4 monthly incidence of SARS-CoV-2 infection based on serial sero-surveys	Sero-prevalence of COVID will be assessed at baseline, 4 months, 8 months and 12 months
III. Estimate cumulative sero-conversion of SARS-CoV-2 infection over one year period	Sero-prevalence of COVID will be assessed at baseline, 4 months, 8 months and 12 months
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 Measures

Name	Time	Method
Secondary objectives	I. Monitor the trend of SARS-CoV-2 transmission in the general population

Trial Locations

Locations (1): The INCLEN Trust International
🇮🇳
South, DELHI, India
The INCLEN Trust International
🇮🇳South, DELHI, India
Shikha Dixit
Principal investigator
9810618897
shikha.dixit@inclentrust.org