SARS-CoV-2 Disguise Study

• Conditions: Sars-CoV2
• Interventions: Diagnostic Test: SARS-CoV-2-test; Other: SARS-CoV-2 questionnaire survey

• Registration Number: NCT04395794
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-07
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20
• Primary Completion: 2020-08-31
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical Employees	SARS-CoV-2-test	Asymptomatic medical employees in high-volume cardiovascular center.
Medical Employees	SARS-CoV-2 questionnaire survey	Asymptomatic medical employees in high-volume cardiovascular center.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Predictors (symptomatic)	8 weeks	Predictors of symptomatic form transformation
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
Percentage from different departments	8 weeks	Percentage of employees from different departments with SARS-CoV-2 positive carriers

Trial Locations

Locations (1)

Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Russian Federation