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

Covid-19 Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368884
• Other study ID #: Covid-19/MHC-2/2020
• Status: Recruiting
• Start date: April 22, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2020
• Source: Max Healthcare Insititute Limited
• Contact: Sujeet Jha, MRCP (U.K)
• Phone: 09910609000
• Email: sujeet.jha[@]maxhealthcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19

Locations

Country	Name	City	State
India	Max Super Speciality Hospital, A Unit of Devki Devi Foundation	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of antibodies	Samples will be assessed for the presence of IgG and IgM	4-8 weeks