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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Covid-19

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthcare workers<br>The healthcare workers who are being tested for COVID-19 would be included in this group | |
| OPD patients<br>Individuals outside from the hospital who are coming for the COVID-19 testing will be included in this group | |
| IPD COVID-19 cases<br>Admitted positive cases of COVID-19 in the hospital will be included in this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of antibodies | Samples will be assessed for the presence of IgG and IgM | 4-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seroconversion, Healthcare Workers, COVID-19