Covid19NCT04563247
Seroprevalence of SARS-CoV-2 in Asymptomatic Frontline COVID-19 HCWs
An observational study of Covid19, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
This study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Covid19
- What is being tested?
- IgG SARS CoV 2 antibodies
- How many people
- 970 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 8 Feb 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 20 to 60 years
- All sexes
- Adult
Study population: Healthcare workers who have been working in high exposure areas of COVID 19 and havenot developed disease themselves while working in that area
Who may be able to join
- All HCWs who had been working in high exposure areas of COVID 19
Who cannot join
- Any HCW of high exposure areas of COVID 19 who suffered from COVID 19 themselves diagnosed on PCR or clinically
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of SARS-CoV 2 Among Asymptomatic Frontline Healthcare Workers During COVID 19: A Cross Sectional Study
This study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.
Read the detailed description
Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear. Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients. Asymptomatic cases are common but to date there are scarce epidemiological surveys that provide a clear percentage of asymptomatic cases.
A large number of healthcare workers have been infected with the virus worldwide, presenting with severe symptoms to no symptoms at all, in which case being diagnosed on contact tracing only. The seropositivity rate in previously undiagnosed healthcare workers has been reported in different regions of the world. In a combined study of three hospitals of Turkey, the seropositivity rate of the previously undiagnosed HCWs was 2.7%. A study done in China revealed 17.5 % seropositivity rate.
This study will aim to comprehensively review the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.
- Conditions
- Covid19
- Being tested
- IgG SARS CoV 2 antibodies
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG SARS CoV 2 antibodiesDiagnostic test
The asymptomatic healthcare workers of high exposure COVID19 areas will be tested for IgG SARS CoV 2 antibodies
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic frontline HCWs for COVID 19 | All healthcare workers who worked in high exposure areas of hospital dealing with COVID 19. Receives: Diagnostic Test: IgG SARS CoV 2 antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS CoV 2 IgG antibodies
The presence or absence of SARS CoV 2 antibodies in serum of HCWs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Jul 2020
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Retrospective
- Enrolment
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amina Asif, Lahore General Hospital
- Investigators
- Amina Asif, MPhilMicro, Principal investigator, LahoreGeneralHospital.Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563247
- Sponsor's protocol ID
- LGH002
- Status last verified
- Feb 2022
- First submitted
- 20 Sep 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of SARS-CoV 2 Among Asymptomatic Frontline Healthcare Workers During COVID 19: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04563247
- Acronym / sponsor ID
- LGH002
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 24 Sep 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.
This study is about the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.
Detailed description
Coronaviruses (CoVs) are enveloped, single positive-strand RNA viruses belonging to the large subfamily Coronavirinae, which can infect mammals and several other animals.The continued spread of coronavirus disease 2019 (COVID-19) has prompted widespread concern around the world, and the World Health Organization (WHO), on 11 March 2020, declared COVID-19 a pandemic. Studies on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) showed that virus-specific antibodies were detectable in 80-100% of patients at 2 weeks after symptom onset. Currently, the antibody responses against SARS-CoV-2 remain poorly understood and the clinical utility of serological testing is unclear. Little is known about the kinetics, tissue distribution, cross-reactivity and neutralization antibody response in COVID-19 patients. Asymptomatic cases are common but to date there are scarce epidemiological surveys that provide a clear percentage of asymptomatic cases.
A large number of healthcare workers have been infected with the virus worldwide, presenting with severe symptoms to no symptoms at all, in which case being diagnosed on contact tracing only. The seropositivity rate in previously undiagnosed healthcare workers has been reported in different regions of the world. In a combined study of three hospitals of Turkey, the seropositivity rate of the previously undiagnosed HCWs was 2.7%. A study done in China revealed 17.5 % seropositivity rate.
This study will aim to comprehensively review the current knowledge on the immunological changes observed in various healthcare workers in this part of the world, who remained asymptomatic while working in high exposure areas of COVID-19 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic frontline HCWs for COVID 19 | – | Diagnostic Test: IgG SARS CoV 2 antibodiesAll healthcare workers who worked in high exposure areas of hospital dealing with COVID 19. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthcare workers who have been working in high exposure areas of COVID 19 and havenot developed disease themselves while working in that area
Key inclusion criteria (1 listed)
- All HCWs who had been working in high exposure areas of COVID 19
Key exclusion criteria (1 listed)
- Any HCW of high exposure areas of COVID 19 who suffered from COVID 19 themselves diagnosed on PCR or clinically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgG SARS CoV 2 antibodiesThe asymptomatic healthcare workers of high exposure COVID19 areas will be tested for IgG SARS CoV 2 antibodies | Diagnostic test | Asymptomatic frontline HCWs for COVID 19 |
Primary outcome
SARS CoV 2 IgG antibodies
Time frame: 3 months
The presence or absence of SARS CoV 2 antibodies in serum of HCWs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Amina Asif, MPhilMicro principal investigator
LahoreGeneralHospital.Lahore
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 Covid19, run by Lahore General Hospital at 1 site in Pakistan.
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 1 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: finished, as of the sponsor's last update on 15 Feb 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS CoV 2 IgG antibodies (time frame: 3 months). 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 15 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.