NCT04838119

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375,692

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2021

Completed
Last Updated

August 26, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

April 7, 2021

Last Update Submit

August 24, 2021

Conditions

COVID-19

Keywords

Testing, preoperative

Outcome Measures

Primary Outcomes (1)

  • Percentage of asymptomatic preoperative COVID-19 positive testing

    March 2020-February 2021

Secondary Outcomes (4)

  • Percentage of hospitalization per geographic area

    March 2020-February 2021

  • Percentage of death per geographic area

    March 2020-February 2021

  • ICU census per geographic area

    March 2020-February 2021

  • Percentage of asymptomatic preoperative COVID-19 positive testing per geographic area

    March 2020-February 2021

Study Arms (1)

Patients with a preoperative asymptomatic COVID screening test

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Publicly reported aggregate data on asymptomatic preoperative COVID tests (no individual patient information)

You may qualify if:

  • having preoperative asymptomatic COVID testing
  • \> or = 18 years of age

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • B S Segal, MD

    Wake Forest Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 8, 2021

Study Start

April 1, 2021

Primary Completion

August 23, 2021

Study Completion

August 23, 2021

Last Updated

August 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)