SARS COV-2 IgG Levels on Health WorkersNCT04845880
SARS Cov_2 Incidence of Healthy Health Workers
A study testing Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2 in people with SARS COV-2 IgG Levels on Health Workers, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Since the severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) first emerged in Wuhan, China, on 12 December 2019, it has spread rapidly across the world and developed into a pandemic. The pandemic has affected over 100 countries and regions, with over 132 million confirmed cases of COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS COV-2 IgG Levels on Health Workers
- What is being tested?
- Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Apr 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Health Workers - SARS COV-2 PCR (-)
Who cannot join
- Health Workers - SARS COV-2 PCR (+) Pregnancy Autoimmune diseases Received immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana Dr. Turgut Noyan Application and Research Center
Adana
About this study
Official title: Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 Patients in Our Hospital
Since the severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) first emerged in Wuhan, China, on 12 December 2019, it has spread rapidly across the world and developed into a pandemic. The pandemic has affected over 100 countries and regions, with over 132 million confirmed cases of COVID-19. The rapid spread of SARS-CoV-2 has caused considerable harm to public health and the economy. Alongside other laboratory tests and clinical findings of the COVID-19 infection, serological testing may be beneficial for epidemiological monitoring and outbreak control. The determination of antibodies enables confirmation of the SARS-CoV-2 infection in asymptomatic patients in addition to those with typical symptoms. In this study, we aimed to determine the SARS-CoV-2 seroprevalence and the IgG antibody levels among healthcare workers who frequently encountered COVID-19 patients in our hospital.
- Conditions
- SARS COV-2 IgG Levels on Health Workers
- Being tested
- Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2Diagnostic test
Blood level of spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| SARS Cov_2 Incidence of Healthy Health Workers | Other | Not described Receives: Diagnostic Test: Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 patients in Our Hospital
Determining antibody levels and seroprevalence of healthy healthcare workers
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 posted15 Apr 2021
- Study start1 Oct 2020
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
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 SARS COV-2 IgG Levels on Health WorkersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Hikmet Eda Aliskan, Hatice Hale Gumus, Ilker Odemis, Zuhal Ekici Unsal
- Responsible party
- Principal investigator, Hasan Yesilagac, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845880
- Sponsor's protocol ID
- KA20/449
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang W, Cao Q, Qin L, Wang X, Cheng Z, Pan A, Dai J, Sun Q, Zhao F, Qu J, Yan F. Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease (COVID-19):A multi-center study in Wenzhou city, Zhejiang, China. J Infect. 2020 Apr;80(4):388-393. doi: 10.1016/j.jinf.2020.02.016. Epub 2020 Feb 26.
PubMed 32112884Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
PubMed 31986261
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 Patients in Our Hospital
- ClinicalTrials.gov ID
- NCT04845880
- Acronym / sponsor ID
- KA20/449
- Conditions
- SARS COV-2 IgG Levels on Health Workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Hikmet Eda Aliskan, Hatice Hale Gumus, Ilker Odemis, Zuhal Ekici Unsal
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 15 Apr 2021 (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.
Since the severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) first emerged in Wuhan, China, on 12 December 2019, it has spread rapidly across the world and developed into a pandemic. The pandemic has affected over 100 countries and regions, with over 132 million confirmed cases of COVID-19. The rapid spread of SARS-CoV-2 has caused considerable harm to public health and the economy. Alongside other laboratory tests and clinical findings of the COVID-19 infection, serological testing may be beneficial for epidemiological monitoring and outbreak control. The determination of antibodies enables confirmation of the SARS-CoV-2 infection in asymptomatic patients in addition to those with typical symptoms. In this study, we aimed to determine the SARS-CoV-2 seroprevalence and the IgG antibody levels among healthcare workers who frequently encountered COVID-19 patients in our hospital.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS Cov_2 Incidence of Healthy Health Workers | Other | Diagnostic Test: Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Health Workers - SARS COV-2 PCR (-)
Key exclusion criteria (1 listed)
- Health Workers - SARS COV-2 PCR (+) Pregnancy Autoimmune diseases Received immunosuppressive therapy
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 |
|---|---|---|
| Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2Blood level of spike protein (S) or the nucleocapsid (N) of SARS-CoV-2 | Diagnostic test | SARS Cov_2 Incidence of Healthy Health Workers |
Primary outcome
Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 patients in Our Hospital
Time frame: 6 months
Determining antibody levels and seroprevalence of healthy healthcare workers
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 Apr 2021.
- Background: PubMed 32112884Yang W, Cao Q, Qin L, Wang X, Cheng Z, Pan A, Dai J, Sun Q, Zhao F, Qu J, Yan F. Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease (COVID-19):A multi-center study in Wenzhou city, Zhejiang, China. J Infect. 2020 Apr;80(4):388-393. doi: 10.1016/j.jinf.2020.02.016. Epub 2020 Feb 26.
- Background: PubMed 31986261Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.
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?
A study testing Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2 in people with SARS COV-2 IgG Levels on Health Workers, run by Baskent University at 1 site in Turkey (Türkiye).
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 Apr 2021. 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 Turkey (Türkiye). 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?
Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 patients in Our Hospital (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 NCT04845880, 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 15 Apr 2021.