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UnknownNCT04368884

Assess the Seroconversion Status of Health Care Workers Suspected or Confirmed Cases of COVID-19 Patients

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)

Status
Unknown
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
Max Healthcare Insititute Limited · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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 The study population would include all employees of Max Hospitals, Delhi-NCR, who have been tested for COVID-19. Samples and data of the COVID positive patients admitted in the hospital will also be collected and OPD patients coming to the hospital for COVID-19 testing will be one of the study subsets.

Conditions

Timeline

Start date
2020-04-22
Primary completion
2021-06-30
Completion
2021-07-30
First posted
2020-04-30
Last updated
2020-07-22

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT04368884. Inclusion in this directory is not an endorsement.