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

NCT04473183 | Withdrawn

• 1 other identifier: SURG-2020-28863
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV Infection; SARS-CoV-2; Corona Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  1 year

Study Arms (3)

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

Specimen Collection DIAGNOSTIC_TEST

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.

General Healthy Population; Individuals who are HIV positive; Medical School Residents

Surveys DIAGNOSTIC_TEST

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.

General Healthy Population; Individuals who are HIV positive; Medical School Residents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

With the participant's approval, and as approved by IRB, de-identified biological samples will be stored and tested for anti- SARS-CoV-2 IgG and IgM. These samples may be used in future COVID-19 studies to develop assays or study other features of the disease. These leftovers may be used for multiple basic science analysis and potentially for genetic testing. The consent process will explain this to prospective participants. During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research. However, withdrawal of consent with regard to biosample storage will not be possible after the study is completed. The consent process will explain this to prospective participants.

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections

Interventions

Specimen Handling; Fertility

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Luca Schifanella, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 16, 2020
• Study Start: July 21, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

US (1)