A study to observe the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population.

Not yet recruiting

Conditions: Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: A90||Dengue fever [classical dengue], (3) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere,

Registration Number: CTRI/2020/11/028968

Lead Sponsor: National Biopharma Mission NBM Biotechnology Industry Research Assistance Council BIRAC

Brief Summary: As part of the clinical trial network beingset up by National Biopharma Mission (NBM)-Biotechnology Industry ResearchAssistance Council (BIRAC), four existing demographc surveillance sites (also referredto as Demographic Health Surveillance sites-DHS)/Health and Demographic SurveillanceSites-HDSS) /Demographic, Developmental and Environmental Surveillance Sites-DDESS)were selected to study epidemiology of Dengue & Chikungunya in differentage-groups over a period of three years. This study design involvedidentification of lab confirmed cases of dengue/ chikungunya through activefebrile illness (AFI) surveillance; and three rounds of sero-surveys in acohort of 1500 individuals (2-50 years) at each site. Serum samples collectedin this study would be stored in a centralised bio-repository for explorationof various aetiologies of AFI if required. These sites were expected toundertake community based trials for indigenous dengue/chikungunya vaccines infuture.

In view of the COVID-19 pandemic, it was decidedthat these sites with established community presence and experience ofmaintaining population cohorts could be leveraged to fill knowledge gapsrelated to the actual burden of COVID disease in the community as well as toimprove understanding of the community transmission dynamics. A fifth site fromPune district of Maharashtra was added for COVID specific research objectivesto ensure representation from the Western part of the country.

While a cohort design with active febrileillness (AFI) surveillance appears to be the most comprehensive study design,it is associated with numerous operational challenges at this point of time:

The sample size required to generate areasonable estimate of incidence of COVID would be high (>5000)

The feasibility of collecting NP swabs /saliva samples for COVID-19 confirmation in community settings is challenging,resource intensive, associated with risk of stigma, community push back andrisk to staff.

The follow-up protocol for any positive caseidentified is operationally difficult to follow as part of this study.

In view of this, an approach involving followup of a defined population cohort through repeated serological surveys andsyndromic acute febrile illness/Influenza like illness surveillance throughfortnightly phone calls (without labconfirmation) to record suspected cases of COVID-19 was considered to be themost feasible study design operationally and scientifically. With 6-8 vaccineprojects being supported by the National Biopharma Mission, BIRAC, data fromthese sites will be useful in decisions related to selection of vaccine trialsites. Also, when actual vaccine introduction takes place, the information onburden of these syndromes will be useful to plan logistics for requiredinvestigations in these cases.

Though the pandemic in India was largelyrestricted to metros and urban cities in the first few months, it has nowreached rural areas as well due to the mass exodus of migrant workers. Theselected sites represent a mix of rural and urban population and present an opportunityto estimate burden in both the settings.

To align with the original mandate with whichBIRAC had selected these sites, two rounds of serological testing of dengue andchikungunya is proposed to be done in the same cohort to estimate the burden ofthese diseases in the community. The original protocol prepared for the studyon Dengue and Chikungunya epidemiology study shall be implemented after the COVIDpandemic subsides.

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 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

Consent refusal.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Determining the burden of COVID 19 infection at the community level and monitor the trends in transmission of SARS-CoV-2 infection.	Outcome 1: 12 months \| Outcome 2: 12 months
2.Risk factors for infection can be identified which might inform future control strategies.	Outcome 1: 12 months \| Outcome 2: 12 months

Secondary Outcome Measures

Name	Time	Method
The serial surveys in the same set of individuals will help in measuring the antibody levels over a period of time and understand the proportion of individuals who are able to mount a neutralisation response and the duration for which immunity lasts after infection.	12 months

Trial Locations

Locations (1): ICMR - National Institute of Epidemiology
🇮🇳
Tirunelveli, TAMIL NADU, India
ICMR - National Institute of Epidemiology
🇮🇳Tirunelveli, TAMIL NADU, India
DrYuvarajJayaraman
Principal investigator
9843323166
j_yuvan@yahoo.com