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SARS-CoV-2 Disguise Study (Disguise)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395794
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sars-CoV2 Diagnostic Test: SARS-CoV-2-test Other: SARS-CoV-2 questionnaire survey

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Official Title: SARS-CoV-2 Positive Carriers Among Asymptomatic meDIcal employeeS in hiGh-volUme cardIovaScular cEnter
Actual Study Start Date : May 7, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : November 30, 2020

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Transformation [ Time Frame: 8 weeks ]
    Percentage of transformation from asymptomatic SARS-CoV-2 positive carriers to symptomatic form

  2. Predictors (asymptomatic) [ Time Frame: 8 weeks ]
    Predictors of the asymptomatic SARS-CoV-2 positive carriers

  3. Predictors (symptomatic) [ Time Frame: 8 weeks ]
    Predictors of symptomatic form transformation

  4. Percentage from different departments [ Time Frame: 8 weeks ]
    Percentage of employees from different departments with SARS-CoV-2 positive carriers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asymptomatic medical employees in high-volume cardiovascular center
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395794


Contacts
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Contact: Alexander B Romanov, PhD +79137172652 abromanov@mail.ru

Locations
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Russian Federation
Meshalkin National Medical Research Center Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Alexander B Romanov, PhD    +79137172652    abromanov@mail.ru   
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         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT04395794    
Other Study ID Numbers: CS-COVID-19
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No