SARS-CoV-2 Disguise Study

NCT04395794 — Unknown, 900 participants, Meshalkin Research Institute of Pathology of Circulation

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SARS-CoV-2 Positive Carriers Among Asymptomatic meDIcal employeeS in hiGh-volUme cardIovaScular cEnter

Registry	NCT04395794, acronym Disguise
Status	Unknown
Study type	Observational
Enrollment	900 (Estimated)
Sponsor	Meshalkin Research Institute of Pathology of Circulation (Network)
Conditions	Sars-CoV2
Interventions	SARS-CoV-2-test, SARS-CoV-2 questionnaire survey (Diagnostic test, other)
Dates	start 2020-05-07, primary completion 2020-08-31 (estimated), completion 2020-11-30 (estimated), first posted 2020-05-20, last updated 2020-05-20
Locations	1 site in Russia

-Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a pandemic disease with worldwide spreading. Limited data are existed regarding SARS-CoV-2 positive carriers among asymptomatic medical employees in non-profile infectious clinic, e.g. cardiovascular clinic, routinely working in the pandemic region with two million inhabitants. The aim is to test the percentage and increase of the SARS-CoV-2 positive carriers among asymptomatic medical employees in high-volume cardiovascular center in routine clinical practice.

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+Arms and interventions

Arm	Type	Interventions	Description
Medical Employees		Diagnostic Test: SARS-CoV-2-test; Other: SARS-CoV-2 questionnaire survey	Asymptomatic medical employees in high-volume cardiovascular center.

SARS-CoV-2-test (Diagnostic test): Nasopharyngeal and oropharyngeal testing for SARS-CoV-2
SARS-CoV-2 questionnaire survey (Other): Questionnaire regarding SARS-CoV-2 symptoms and contact with COVID patients

+Outcome measures

Primary outcomes

SARS-CoV-2 positive test [8 weeks]: Percentage of SARS-CoV-2 positive tests and increase of SARS-CoV-2 positive test between 1 st , 2 nd and 3 rd time frame testing

Secondary outcomes

Transformation [8 weeks]: Percentage of transformation from asymptomatic SARS-CoV-2 positive carriers to symptomatic form
Predictors (asymptomatic) [8 weeks]: Predictors of the asymptomatic SARS-CoV-2 positive carriers
Predictors (symptomatic) [8 weeks]: Predictors of symptomatic form transformation
Percentage from different departments [8 weeks]: Percentage of employees from different departments with SARS-CoV-2 positive carriers

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Asymptomatic medical employees of E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
* Filled questionnaire before SARS-CoV-2 testing
* Nasopharyngeal and oropharyngeal testing for SARS-CoV-2
* Signed informed consent

Exclusion Criteria:

* Unwilling to participate

+Locations (1)

Facility	City	Country	Status
Meshalkin National Medical Research Center	Novosibirsk	Russia	Recruiting