Seroprevalence of SARS-CoV-2 in Unselected Surgical Patie... | NCT04839913

Studies
Seroprevalence of SARS-CoV-2 in Unselected Surgical Patients: an Unicentric, Regional Study

NCT04839913

Sponsor

University of Cagliari

Status

Completed

Last Update Posted

Apr 9, 2021Actual

Enrollment

121Actual

Phase

Not provided

Conditions

SARS-CoV Infection
Seroprevalence
Covid19

Interventions

Antibodies testing

Countries

Italy

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

Apr 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

Sep 1, 2020Actual

Primary Completion Date

Dec 10, 2020Actual

Completion Date

Jan 10, 2021Actual

First Submitted Date

Apr 7, 2021

First Submission Date that Met QC Criteria

Apr 8, 2021

First Posted Date

Apr 9, 2021Actual

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

Apr 8, 2021

Last Update Posted Date

Apr 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 investigator analyzed the data of the patients admitted to the surgical department during the period 1St September - 10Th December 2020 to estimate the seroprevalence of SARS-CoV-2 infection in the setting of a non-dedicated COVID-19 hospital and in a mild CoV-2 incidence area and to evaluate the difference of seroprevalence between Spring and Fall seasons in a cohort of patients undergoing surgery.

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

121Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibodies testing	Diagnostic Test	Serologic test for both SARS-COV-2 IgG and IgM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SARS-COV-2 seroprevalence	SARS-COV-2 IgG and IgM seroprevalence between spring and fall period	1St September - 10Th December 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient admitted to our unit who had performed SARS-COV-2 serologic test

Exclusion Criteria:

age < 18

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

This is a cohort of elective surgical patients admitted to our unit in the 2020 fall period

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cagliari		Cagliari			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045169	Severe Acute Respiratory Syndrome
D000086382	COVID-19

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D018352	Coronavirus Infections
D003333	Coronaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided