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NCT04395794 Clinical Trial

SARS-CoV-2 Disguise Study

Sars-CoV2 Clinical Trial

— Disguise  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04395794
Other study ID # CS-COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 7, 2020
Est. completion date November 30, 2020

Study information
Verified date May 2020
Source Meshalkin Research Institute of Pathology of Circulation
Contact Alexander B Romanov, PhD
Phone +79137172652
Email abromanov@mail.ru
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 900
Est. completion date November 30, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Russian Federation Meshalkin National Medical Research Center Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary SARS-CoV-2 positive test 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 8 weeks
Secondary Transformation Percentage of transformation from asymptomatic SARS-CoV-2 positive carriers to symptomatic form 8 weeks
Secondary Predictors (asymptomatic) Predictors of the asymptomatic SARS-CoV-2 positive carriers 8 weeks
Secondary Predictors (symptomatic) Predictors of symptomatic form transformation 8 weeks
Secondary Percentage from different departments Percentage of employees from different departments with SARS-CoV-2 positive carriers 8 weeks
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