Covid-19NCT04368884
Assess the Seroconversion Status of Health Care Workers Suspected or Confirmed Cases of COVID-19 Patients
An observational study of Covid-19, run by Max Healthcare Insititute Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- 22 Apr 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Refusal to give informed consent, or contraindication to venipuncture.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Max Super Speciality Hospital, A Unit of Devki Devi Foundation
New Delhi, National Capital Territory of Delhi, 110017
Samreen Siddiqui, PhD, 9582865898, samreensiddiqui@maxhealthcare.com
Sujeet Jha, MRCP (U.K)
About this study
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)
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.
Read the 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.
- Conditions
- Covid-19
- Keywords
- Seroconversion, Healthcare Workers, COVID-19
- Medical subject headings
- COVID-19, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of antibodies
Samples will be assessed for the presence of IgG and IgM
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start22 Apr 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujeet Jha, MRCP (U.K), Principal investigator, Max Healthcare Institute Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368884
- Sponsor's protocol ID
- Covid-19/MHC-2/2020
- Status last verified
- Jul 2020
- First submitted
- 29 Apr 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet prepared an IPD sharing protocol at this stage. Data might be shared if requested.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04368884
- Acronym / sponsor ID
- Covid-19/MHC-2/2020
- Conditions
- Covid-19
- Keywords
- Seroconversion, Healthcare Workers, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to give informed consent, or contraindication to venipuncture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of antibodies
Time frame: 4-8 weeks
Samples will be assessed for the presence of IgG and IgM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Undecided. We have not yet prepared an IPD sharing protocol at this stage. Data might be shared if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujeet Jha, MRCP (U.K) principal investigator
Max Healthcare Institute Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Max Healthcare Insititute Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujeet Jha, MRCP (U.K) (09910609000, sujeet.jha@maxhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of antibodies (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.