SARS COV-2 IgG Levels on Health Workers Clinical Trial
Official title:
Evaluation of IgG Neutralizing Antibodies to SARS-CoV-2 Among Healthcare Workers Who Frequently Encountered COVID-19 Patients in Our Hospital
| NCT number | NCT04845880 |
| Other study ID # | KA20/449 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 1, 2020 |
| Est. completion date | April 1, 2021 |
| Verified date | April 2021 |
| Source | Baskent University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 182 |
| Est. completion date | April 1, 2021 |
| Est. primary completion date | March 1, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: Healthy Health Workers - SARS COV-2 PCR (-) Exclusion Criteria: Health Workers - SARS COV-2 PCR (+) Pregnancy Autoimmune diseases Received immunosuppressive therapy |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Adana Dr. Turgut Noyan Application and Research Center | Adana |
| Lead Sponsor | Collaborator |
|---|---|
| Baskent University | Hatice Hale Gumus, Hikmet Eda Aliskan, Ilker Odemis, Zuhal Ekici Unsal |
Turkey,
Chan 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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 months |