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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368884
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Covid-19

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : April 22, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Healthcare workers
The healthcare workers who are being tested for COVID-19 would be included in this group
OPD patients
Individuals outside from the hospital who are coming for the COVID-19 testing will be included in this group
IPD COVID-19 cases
Admitted positive cases of COVID-19 in the hospital will be included in this group



Primary Outcome Measures :
  1. Development of antibodies [ Time Frame: 4-8 weeks ]
    Samples will be assessed for the presence of IgG and IgM


Biospecimen Retention:   Samples Without DNA
Serum and plasma samples are being stored at -70C


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368884


Contacts
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Contact: Sujeet Jha, MRCP (U.K) 09910609000 sujeet.jha@maxhealthcare.com
Contact: Samreen Siddiqui, PhD 09582865898 samreensiddiqui@maxhealthcare.com

Locations
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India
Max Super Speciality Hospital, A Unit of Devki Devi Foundation Recruiting
New Delhi, Delhi, India, 110017
Contact: Samreen Siddiqui, PhD    9582865898    samreensiddiqui@maxhealthcare.com   
Principal Investigator: Sujeet Jha, MRCP (U.K)         
Sub-Investigator: Samreen Siddiqui, PhD         
Sub-Investigator: Swati Waghdhare, MD         
Sponsors and Collaborators
Max Healthcare Insititute Limited
Investigators
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Principal Investigator: Sujeet Jha, MRCP (U.K) Max Healthcare Institute Ltd.
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Responsible Party: Max Healthcare Insititute Limited
ClinicalTrials.gov Identifier: NCT04368884    
Other Study ID Numbers: Covid-19/MHC-2/2020
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have not yet prepared an IPD sharing protocol at this stage. Data might be shared if requested.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Max Healthcare Insititute Limited:
Seroconversion
Healthcare Workers
COVID-19