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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04368884
Enrollment
1000
Registered
2020-04-30
Start date
2020-04-22
Completion date
2021-07-30
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19

Keywords

Seroconversion, Healthcare Workers, COVID-19

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.

Interventions

None listed

Sponsors

Max Healthcare Insititute Limited
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Development of antibodies4-8 weeksSamples will be assessed for the presence of IgG and IgM

Countries

India

Contacts

Primary ContactSujeet Jha, MRCP (U.K)
sujeet.jha@maxhealthcare.com09910609000
Backup ContactSamreen Siddiqui, PhD
samreensiddiqui@maxhealthcare.com09582865898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026