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WithdrawnNCT04473183Updated Aug 15, 2022

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

An observational study in Covid19, SARS-CoV Infection and SARS-CoV-2, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-15.

Sponsored by University of Minnesota · Observational

Why this study was withdrawn
PI left the University, and the study was not funded.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

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Conditions studied

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In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Group 1 are members of general healthy population. Group 2 are medical residents. Group 3 are individuals who test positive for HIV infection.

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

Exclusion criteria

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • General Healthy Population

    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.

    Diagnostic Test: Specimen Collection · Diagnostic Test: Surveys

  • Medical School Residents

    Participants in this group are medical school residents.

    Diagnostic Test: Specimen Collection · Diagnostic Test: Surveys

  • Individuals who are HIV positive

    Participants in this group are HIV positive.

    Diagnostic Test: Specimen Collection · Diagnostic Test: Surveys

Interventions

  • Diagnostic testSpecimen Collection

    Blood: Two tubes of blood (up to 10 ml each) will be drawn from participants and will be collected by experienced phlebotomists. Nasal, oral, and rectal swabs: Nasal, oral, and rectal swabs are optional specimens that patients may be asked to donate. If prospective consent is provided, swabs will be self-collected by participants after receiving clear instructions from the team and collected in the dedicated container. Saliva: Saliva is an optional specimen that patients may be asked to donate. If prospective consent is provided, whole saliva samples will be self-collected by participants using a pad placed between the cheek and gum for 2-5 minutes or collecting the saliva directly to a sterile container.

  • Diagnostic testSurveys

    Participants will be asked to fill out a brief online survey that will investigate symptoms consistent with SARS-CoV-2 infection in the past 3 months and the geographic location of the clinic(s) they work in (if a resident of a medical school) and their comorbidities related to SARS-CoV-2.

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What researchers measure

Primary outcomes

  1. Prevalence of Symptomatic Infection

    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.

    Time frame: 1 year

  2. Prevalence of Subclinical Infection

    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.

    Time frame: 1 year

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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04473183
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jul 16, 2020
Start date
Jul 21, 2020 (estimated)
Primary completion
Jan 2022 (estimated)
Completion
Jan 2022 (estimated)
Last update
Aug 15, 2022

Study contacts

Luca Schifanella, MD, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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