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

NCT ID: NCT04368884

Last Updated: 2020-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-22

Study Completion Date

2021-07-30

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.

Conditions

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Covid-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthcare workers

The healthcare workers who are being tested for COVID-19 would be included in this group

No interventions assigned to this group

OPD patients

Individuals outside from the hospital who are coming for the COVID-19 testing will be included in this group

No interventions assigned to this group

IPD COVID-19 cases

Admitted positive cases of COVID-19 in the hospital will be included in this group

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Max Healthcare Insititute Limited

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sujeet Jha, MRCP (U.K)

Role: PRINCIPAL_INVESTIGATOR

Max Healthcare Institute Ltd.

Locations

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Max Super Speciality Hospital, A Unit of Devki Devi Foundation

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Sujeet Jha, MRCP (U.K)

Role: CONTACT

09910609000

Samreen Siddiqui, PhD

Role: CONTACT

09582865898

Facility Contacts

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Samreen Siddiqui, PhD

Role: primary

9582865898

Other Identifiers

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Covid-19/MHC-2/2020

Identifier Type: -

Identifier Source: org_study_id

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