- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04473183
Epidemiologic Assessment of SARS-CoV-2 (COVID-19) Prevalence in Minnesota
Epidemiologic Assessment of SARS-CoV-2 Prevalence in Minnesota
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Kontakter och platser
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
|
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.
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.
|
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.
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.
|
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Prevalence of Symptomatic Infection
Tidsram: 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.
|
1 year
|
Prevalence of Subclinical Infection
Tidsram: 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.
|
1 year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Luca Schifanella, MD, PhD, University of Minnesota
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Luftvägsinfektioner
- Luftvägssjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Sjukdomsegenskaper
- Svår akut respiratorisk sjukdom
- Covid-19
- Coronavirusinfektioner
- Infektioner
- Smittsamma sjukdomar
Andra studie-ID-nummer
- SURG-2020-28863
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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