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

July 20, 2020 updated by: Max Healthcare Insititute Limited

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)

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110017
        • Recruiting
        • Max Super Speciality Hospital, A Unit of Devki Devi Foundation
        • Principal Investigator:
          • Sujeet Jha, MRCP (U.K)
        • Contact:
        • Sub-Investigator:
          • Samreen Siddiqui, PhD
        • Sub-Investigator:
          • Swati Waghdhare, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All employees of Max Hospital, Saket and Smart, New Delhi, who are coming to the hospital, working in the COVID ward or the nearby wards, and who would agree to participate will be recruited in this study including those who are being tested in suspicion of COVID-19. Samples and data of the COVID positive patients admitted in the hospital will also be collected. OPD patients coming to the hospital for COVID-19 testing will be one of the study subsets.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthcare workers
The healthcare workers who are being tested for COVID-19 would be included in this group
OPD patients
Individuals outside from the hospital who are coming for the COVID-19 testing will be included in this group
IPD COVID-19 cases
Admitted positive cases of COVID-19 in the hospital will be included in this group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max Healthcare Insititute Limited

Investigators

  • Principal Investigator: Sujeet Jha, MRCP (U.K), Max Healthcare Institute Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Covid-19/MHC-2/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We have not yet prepared an IPD sharing protocol at this stage. Data might be shared if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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