COVID 19NCT04469647
COVID 19 Seroprevalence Amongst Healthcare Workers in JHAH
An observational study of COVID 19, run by Johns Hopkins Aramco Healthcare at 1 site in Saudi Arabia.
Trial summary
Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID 19
- What is being tested?
- Serology Test
- How many people
- 1,200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 19 Jul 2020to 15 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers, divided into two groups (High-risk and Low-risk).
Who may be able to join
- Adult.
- JHAH employee
- Housekeepers (this group of staff are outsourced at JHAH)
Who cannot join
- 1. Any participant exhibiting COVID 19 symptoms
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Johns Hopkins Aramco Healthcare
Dhahran, Eastern Province, 31311
About this study
Official title: COVID 19 Antibody Seroprevalence Amongst Healthcare Workers in Johns Hopkins Aramco Healthcare
Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and undetectably.
Serology is an antibody test that provides additional information to polymerase chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the population that was infected . Seroconversion is the development of antibodies in the blood which can confirm suspected cases after the fact and reveal who was infected but asymptomatic and never realized it. Antibodies are specific proteins created as the body's response to the infection and this test is essential for detecting infected individuals with few or no symptoms at all.
- Conditions
- COVID 19
- Being tested
- Serology Test
- Keywords
- COVID 19, Coronavirus, SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology TestDiagnostic test
Participants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2).
at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test.
| Study group | Role | What they receive |
|---|---|---|
| High-risk | Employees at high-risk of Coronavirus exposure areas (physicians, nurses, respiratory therapists, radiology technologists, lab technologists, housekeepers) Receives: Diagnostic Test: Serology Test | |
| Low-risk | Employees working at lower risk areas such as (administration, HR, Public relations) Receives: Diagnostic Test: Serology Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion status
Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.
Measured: 6 Months
Secondary outcomes (3)
The proportion of asymptomatic infections among staff who have seroconverted
Seroconversion without clinical manifestation (fever, body aches, headache, sweating, chills + respiratory symptoms (cough dyspnea, sputum) or digestive (nausea / vomiting diarrhea abdominal pain)
Measured: 6 Months
The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH
To identify the durability of antibody seroconversion
Measured: 6 Months
Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers
Age, gender, type of staff, resources
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start19 Jul 2020 (estimated)
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Aramco Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469647
- Sponsor's protocol ID
- IRB20-09
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We are willing to share our data after collection de-identified. We plan to share the data with WHO for their unity studies
Publications
Mushcab H, Al-Tawfiq JA, Babgi A, Ghamdi M, Amir A, Sheikh SS, Darwisheh A, AlObaid A, Masuadi E, AlFattani A, Qahtani S, Al Sagheir A. Longevity of Immunoglobulin-G Antibody Response Against Nucleocapsid Protein Against SARS-CoV-2 Among Healthcare Workers. Infect Drug Resist. 2023 May 31;16:3407-3416. doi: 10.2147/IDR.S400365. eCollection 2023.
PubMed 37283943Mushcab H, Al-Tawfiq JA, Ghamdi M, Babgi A, Amir A, Sheikh SS, Darwisheh A, Alobaid A, Jebakumar AZ, Qahtani S, Al Sagheir A. A Cohort Study of Seroprevalence of Antibodies Against SARS-CoV-2 Infection Among Healthcare Workers at a Tertiary Hospital in Saudi Arabia. Infect Drug Resist. 2022 Aug 10;15:4393-4406. doi: 10.2147/IDR.S369755. eCollection 2022.
PubMed 35974896
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID 19 Antibody Seroprevalence Amongst Healthcare Workers in Johns Hopkins Aramco Healthcare
- ClinicalTrials.gov ID
- NCT04469647
- Acronym / sponsor ID
- IRB20-09
- Conditions
- COVID 19
- Keywords
- COVID 19, Coronavirus, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Johns Hopkins Aramco HealthcareUniversity, hospital or other
- Study start
- 19 Jul 2020 (estimated)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 14 Jul 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.
Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and undetectably.
Serology is an antibody test that provides additional information to polymerase chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the population that was infected . Seroconversion is the development of antibodies in the blood which can confirm suspected cases after the fact and reveal who was infected but asymptomatic and never realized it. Antibodies are specific proteins created as the body's response to the infection and this test is essential for detecting infected individuals with few or no symptoms at all.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-risk | – | Diagnostic Test: Serology TestEmployees at high-risk of Coronavirus exposure areas (physicians, nurses, respiratory therapists, radiology technologists, lab technologists, housekeepers) |
| Low-risk | – | Diagnostic Test: Serology TestEmployees working at lower risk areas such as (administration, HR, Public relations) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers, divided into two groups (High-risk and Low-risk).
Key inclusion criteria (3 listed)
- Adult.
- JHAH employee
- Housekeepers (this group of staff are outsourced at JHAH)
Key exclusion criteria (1 listed)
- 1. Any participant exhibiting COVID 19 symptoms
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 |
|---|---|---|
| Serology TestParticipants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2). at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test. | Diagnostic test | High-risk, Low-risk |
Primary outcome
Seroconversion status
Time frame: 6 Months
Percentage of health care workers with positive serological markers to describe patterns in exposure, re-infection, clinical symptom, serological responses among health care workers based on their baseline serological status over a one year period.
3 secondary outcomes
The proportion of asymptomatic infections among staff who have seroconverted
Time frame: 6 Months
The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH
Time frame: 6 Months
Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 37283943Mushcab H, Al-Tawfiq JA, Babgi A, Ghamdi M, Amir A, Sheikh SS, Darwisheh A, AlObaid A, Masuadi E, AlFattani A, Qahtani S, Al Sagheir A. Longevity of Immunoglobulin-G Antibody Response Against Nucleocapsid Protein Against SARS-CoV-2 Among Healthcare Workers. Infect Drug Resist. 2023 May 31;16:3407-3416. doi: 10.2147/IDR.S400365. eCollection 2023.
- Derived from this study: PubMed 35974896Mushcab H, Al-Tawfiq JA, Ghamdi M, Babgi A, Amir A, Sheikh SS, Darwisheh A, Alobaid A, Jebakumar AZ, Qahtani S, Al Sagheir A. A Cohort Study of Seroprevalence of Antibodies Against SARS-CoV-2 Infection Among Healthcare Workers at a Tertiary Hospital in Saudi Arabia. Infect Drug Resist. 2022 Aug 10;15:4393-4406. doi: 10.2147/IDR.S369755. eCollection 2022.
- Coronavirus disease (COVID-19) technical guidance: The Unity Studies: Early Investigations ProtocolsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We are willing to share our data after collection de-identified. We plan to share the data with WHO for their unity studies
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Johns Hopkins Aramco Healthcare at 1 site in Saudi Arabia.
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 29 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 Saudi Arabia. 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?
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?
Seroconversion status (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469647, which also lists 2 linked publications.
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 29 Jul 2020.