Epidemiologic Assessment of SARS-CoV-2 (COVID-19) Prevalence in Minnesota

Withdrawn

• Conditions: Covid19; SARS-CoV Infection; SARS-CoV-2; Corona Virus Infection
• Interventions: Diagnostic Test: Specimen Collection; Diagnostic Test: Surveys

• Registration Number: NCT04473183
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of this epidemiologic study is to estimate the prevalence and incidence of anti-SARS-CoV-2 antibodies in at-risk, exposed, affected populations. The study will also estimate the risk of SARS-CoV-2 exposure in target population.

Detailed Description

This study is not for real-time diagnostic purposes, guidance for patient care, or the development of a diagnostic test. The research tests performed for this study will not be prioritized over clinical care samples, that research samples will be batched and tested after clinical care samples. This study is a population-based epidemiologic analysis of prevalence of various groups of persons.

Group (1) general healthy population. People 18 years of age and older that have not tested positive for SARS-CoV-2 and who have not sought medical help in the previous 4 months.

Group (2) Medical School Residents , 18 years of age and older that have not tested positive for SARS-CoV-2 Group (3) Individuals who are HIV positive. People 18 years of age and older that have not tested positive for SARS-CoV-2

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Study Start: 2020-07-21
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participants in Group 1 (General Healthy Population) must have no known exposure to SARS-CoV-2 and have not sought medical help in the previous 4 months for SARS-CoV-2-related symptoms
• Participants in Group 2 must be currently enrolled in a medical residency program
• Participants in Group 3 must currently test positive for HIV infection

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Exclusion Criteria

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data (e.g., someone not able to answer the questionnaire because of a psychological condition or an anxiety disorder that is severe).
• Contraindication for routine blood draws (e.g., severe anemia, hemophilia, etc)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General Healthy Population	Specimen Collection	Participants in this group are part of the general healthy population of adults 18 years-of-age and older, not known to be exposed to the virus as reported by potential participants and who have not sought medical help in the previous 4 months.
General Healthy Population	Surveys	Participants in this group are part of the general healthy population of adults 18 years-of-age and older, not known to be exposed to the virus as reported by potential participants and who have not sought medical help in the previous 4 months.
Medical School Residents	Specimen Collection	Participants in this group are medical school residents.
Individuals who are HIV positive	Specimen Collection	Participants in this group are HIV positive.
Individuals who are HIV positive	Surveys	Participants in this group are HIV positive.
Medical School Residents	Surveys	Participants in this group are medical school residents.

Primary Outcome Measures

Name	Time	Method
Prevalence of Symptomatic Infection	1 year	Prevalence of symptomatic infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report symptoms of SARS-CoV-2 infection.
Prevalence of Subclinical Infection	1 year	Prevalence of subclinical infection will be reported as the percent of participants in each group who test positive for SARS-CoV-2 infection and self-report no symptoms of SARS-CoV-2 infection.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States