Clinical trial NCT04368884: Assess the Seroconversion Status of Health Care Workers Suspected or Confirmed Cases of COVID-19 Patients
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: Seroconversion
Healthcare Workers
COVID-19
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Development of antibodies
timeFrame: 4-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital, A Unit of Devki Devi Foundation
state: Delhi
Study officials:
affiliation: Max Healthcare Institute Ltd.
name: Sujeet Jha, MRCP (U.K)
role: PRINCIPAL_INVESTIGATOR
References: