A Prospective, Longitudinal, Observational Study to Assess the Seroconversion Status of Front Line Health Care Workers and Comparison With the Suspected or Confirmed Cases of COVID-19 Patients at Max Health Care (Project D)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Development of antibodies
Study Overview
Brief Summary
A large number of Health Care Workers (HCWs) would be potentially getting exposed to COVID19. Some of them would be asymptomatic or may get subclinical symptoms. Our HCW would have higher exposure and possibly higher seroconversion either symptomatic or with clinical symptoms than the general population. This study is aimed to understand the rate of seroconversion states at different stages of exposure. It is crucial to collect baseline immune status and the early immunological changes that might occur in asymptomatic or symptomatic health care workers and to compare that with the suspected or confirmed cases by following them for six weeks.
Detailed Description
This prospective observational, longitudinal study is being conducted at Max Super Specialty Hospital, Saket, New Delhi. Below mentioned are the study objectives-
Primary Objectives
- To determine the extent of infection in the healthcare workers (HCW) of a tertiary care hospital in India, by determining the seropositivity
- To compare immune changes that might occur in healthcare workers who are asymptomatic or symptomatic with the proven positive cases in OPD or IPD at Max hospital.
Secondary Objectives
- To determine the fraction of asymptomatic or subclinical infections
- To understand the seroconversion status at different stages of exposure to front line HCW
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthcare workers of Max Hospital, irrespective of age and gender OR
- •COVID-19 positive patients admitted in the hospital OR
- •Out-patients getting tested for COVID-19
Exclusion Criteria
- •Refusal to give informed consent, or contraindication to venipuncture.
Outcomes
Primary Outcomes
Development of antibodies
Time Frame: 4-8 weeks
Samples will be assessed for the presence of IgG and IgM
Secondary Outcomes
No secondary outcomes reported