SARS-CoV-2 /COVID-19 Admission Screening in a University... | NCT04519372

Studies
SARS-CoV-2 /COVID-19 Admission Screening in a University Hospital Setting

NCT04519372

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

May 18, 2021Actual

Enrollment

4,099Actual

Phase

Not provided

Conditions

Covid19
SARS-CoV-2

Interventions

Testing for SARS-CoV-2

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Jun 14, 2020Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Aug 17, 2020

First Submission Date that Met QC Criteria

Aug 17, 2020

First Posted Date

Aug 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2021

Last Update Posted Date

May 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The proportion of asymptomatic carriers of SARS-CoV-2 remains elusive, so the potential benefit of systematic screening during the SARS-CoV-2-pandemic is controversial. We investigate the proportion of asymptomatic inpatients who were identified by systematic screening for SARS-CoV-2 upon hospital admission.

Adult patients admitted to the University Hospital Basel from 01.04.-14.06.2020 were routinely tested for SARS-CoV-2 within 72 hours of admission by nasopharyngeal swabs.

Each patient screened during the study period was retrospectively classified symptomatic or asymptomatic for COVID-19 based on medical chart review.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,099Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testing for SARS-CoV-2	Diagnostic Test	All Patients admitted to the hospital were routinely tested for SARS-CoV-2 within 72 hours of admission by nasopharyngeal swabs.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of SARS-CoV-2 -infected patients	We aim to determine the proportion of SARS-CoV-2-infected patients detected by systematic at-admission screening	01.04.2020-14.06.2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient population is defined as all adult patients hospitalized in the University Hospital Basel from April 1st, 2020 to June 14th, 2020.

Exclusion Criteria:

Outpatients
Patients with SARS-CoV-2 screening in the outpatient test center
Patients with a SARS-CoV-2 test more than 72 hours before hospital admission
Test not performed (for any reason)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The patient population is defined as all patients with an inhospital casenumber and a screening swab for SARS-CoV-2 at the University Hospital Basel from April 1st, 2020 to June 14th, 2020.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Tschudin-Sutter, Prof. Dr. MD	University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology		Basel		4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided