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

Max Healthcare

Status: Unknown

Conditions: Covid-19

Study type: Observational

Funder types: Other

Identifiers

NCT04368884

Covid-19/MHC-2/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 3 patient groups

Healthcare workers

Description:

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

OPD patients

Description:

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

IPD COVID-19 cases

Description:

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