NCT04395794

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 19, 2020

Last Update Submit

May 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Transformation

    8 weeks

  • Predictors (asymptomatic)

    8 weeks

  • Predictors (symptomatic)

    8 weeks

  • Percentage from different departments

    8 weeks

Study Arms (1)

Medical Employees

Asymptomatic medical employees in high-volume cardiovascular center.

Diagnostic Test: SARS-CoV-2-testOther: SARS-CoV-2 questionnaire survey

Interventions

SARS-CoV-2-testDIAGNOSTIC_TEST

Nasopharyngeal and oropharyngeal testing for SARS-CoV-2

Medical Employees

Questionnaire regarding SARS-CoV-2 symptoms and contact with COVID patients

Medical Employees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asymptomatic medical employees in high-volume cardiovascular center

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meshalkin National Medical Research Center

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Interventions

COVID-19 Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Alexander B Romanov, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 20, 2020

Study Start

May 7, 2020

Primary Completion

August 31, 2020

Study Completion

November 30, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations