Epidemiologic Assessment of SARS-CoV-2 (COVID-19) Prevalence in Minnesota
Purpose
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
Eligibility
- Eligible Ages
-
Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
-
Yes
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
- 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)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
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
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 Test: Surveys
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.
|
Medical School Residents
|
Participants in this group are medical school residents.
|
-
Diagnostic Test: Specimen 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 Test: Surveys
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.
|
Individuals who are HIV positive
|
Participants in this group are HIV positive.
|
-
Diagnostic Test: Specimen 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 Test: Surveys
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.
|
Recruiting Locations
More Details
- NCT ID
- NCT04473183
- Status
- Withdrawn
- Sponsor
- University of Minnesota
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