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NCT04838119 Clinical Trial

Preop COVID Testing Patterns

COVID-19 Clinical Trial

Official title:
Preoperative COVID Testing as a Predictor of Community Disease Burden

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04838119
Other study ID # IRB00071985
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date August 23, 2021

Study information
Verified date February 2021
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is an investigation of preoperative asymptomatic COVID screening nationwide. The hypothesis is that because these tests are performed without reference to pretest probability of COVID-19 disease, unlike tests based on symptoms or close contact with infected individuals, these studies may represent a more unbiased sample of the local population prevalence of asymptomatic COVID disease burden.

Description:

Study will gather publicly reported, aggregated statistics on positive COVID tests over time and across geographically diverse parts of the United States, summarized weekly, from the onset of the pandemic in Spring 2020 to the present time. Study will also gather contemporaneous data on weekly community COVID cases diagnosed, local positive test percentage, hospital admissions and ICU admissions for COVID-19, and deaths from COVID 19. Similar data will be obtained from a coalition of approximately 20 academic medical centers from around the United States, with Wake Forest School of Medicine, Department of Anesthesiology serving as the coordinating center. No individual patient information will be collected. Aggregated testing data, hospital disease burden, and local disease prevalence are all publicly reported. Data will analyzed as interrupted time series.

Recruitment information / eligibility
Status Completed
Enrollment 375692
Est. completion date August 23, 2021
Est. primary completion date August 23, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - having preoperative asymptomatic COVID testing - > or = 18 years of age Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of asymptomatic preoperative COVID-19 positive testing March 2020-February 2021
Secondary Percentage of hospitalization per geographic area March 2020-February 2021
Secondary Percentage of death per geographic area March 2020-February 2021
Secondary ICU census per geographic area March 2020-February 2021
Secondary Percentage of asymptomatic preoperative COVID-19 positive testing per geographic area March 2020-February 2021
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