NCT04839913

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

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

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
Last Updated

April 9, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 7, 2021

Last Update Submit

April 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • SARS-COV-2 seroprevalence

    SARS-COV-2 IgG and IgM seroprevalence between spring and fall period

    1St September - 10Th December 2020

Interventions

Antibodies testingDIAGNOSTIC_TEST

Serologic test for both SARS-COV-2 IgG and IgM

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cagliari

Cagliari, Italy

Location

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical researcher

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 9, 2021

Study Start

September 1, 2020

Primary Completion

December 10, 2020

Study Completion

January 10, 2021

Last Updated

April 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations