SARS-CoV-2 Disguise Study (Disguise)

May 19, 2020 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Recruiting
        • Meshalkin National Medical Research Center
        • Sub-Investigator:
          • Vladimir V Lomivorotov, PhD
        • Sub-Investigator:
          • Dmitry N Ponomarev, PhD
        • Sub-Investigator:
          • Denis V Losik, PhD
        • Sub-Investigator:
          • Igor L Mikheenko
        • Sub-Investigator:
          • Vladimir V Beloborodov
        • Sub-Investigator:
          • Nurlan A Elemesov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asymptomatic medical employees in high-volume cardiovascular center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medical Employees
Asymptomatic medical employees in high-volume cardiovascular center.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 positive test
Time Frame: 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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transformation
Time Frame: 8 weeks
Percentage of transformation from asymptomatic SARS-CoV-2 positive carriers to symptomatic form
8 weeks
Predictors (asymptomatic)
Time Frame: 8 weeks
Predictors of the asymptomatic SARS-CoV-2 positive carriers
8 weeks
Predictors (symptomatic)
Time Frame: 8 weeks
Predictors of symptomatic form transformation
8 weeks
Percentage from different departments
Time Frame: 8 weeks
Percentage of employees from different departments with SARS-CoV-2 positive carriers
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2020

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CS-COVID-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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