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Clinical Trials/NCT04368884
NCT04368884
Unknown
Not Applicable

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)

Max Healthcare Insititute Limited1 site in 1 country1,000 target enrollmentApril 22, 2020
ConditionsCovid-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid-19
Sponsor
Max Healthcare Insititute Limited
Enrollment
1000
Locations
1
Primary Endpoint
Development of antibodies
Last Updated
5 years ago

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 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.

Registry
clinicaltrials.gov
Start Date
April 22, 2020
End Date
July 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Max Healthcare Insititute Limited
Responsible Party
Sponsor

Eligibility Criteria

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

Study Sites (1)

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