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

• Conditions: Covid-19

• Registration Number: NCT04368884
• Lead Sponsor: Max Healthcare Insititute Limited

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.

Study Timeline

• Study Start: 2020-04-22
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-22
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of antibodies	4-8 weeks	Samples will be assessed for the presence of IgG and IgM

Trial Locations

Locations (1)

Max Super Speciality Hospital, A Unit of Devki Devi Foundation; 🇮🇳 New Delhi, Delhi, India