Sensitivity Evaluation of Serological Tests for Covid-19 | NCT04678024

Studies
Sensitivity Evaluation of Serological Tests for Covid-19

NCT04678024

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Unknown status

Last Update Posted

Dec 24, 2020Actual

Enrollment

410Estimated

Phase

Not provided

Conditions

Covid19

Interventions

Not provided

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 18, 2020Actual

Primary Completion Date

Aug 2021Estimated

Completion Date

Nov 2021Estimated

First Submitted Date

Dec 17, 2020

First Submission Date that Met QC Criteria

Dec 18, 2020

First Posted Date

Dec 21, 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

Dec 22, 2020

Last Update Posted Date

Dec 24, 2020Actual

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 primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.

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

Retention

Enrollment

410Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity	Sensitivity and Specificity Evaluation in Diagnostic Sierological tests	Up to 22 weeks

Secondary Outcomes

Measure	Description	Time Frame
Specificity	Sensitivity and Specificity Evaluation in Diagnostic Sierological tests	Through study completion, an average of 1 year

Other Outcomes

Measure	Description	Time Frame
HTA		Up to 20 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients or individuals exposed to Sars-Cov2 Infection.

Exclusion Criteria:

There are no criteria for excluding patients or individuals, if not the refusal to participate to project

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients or individuals exposed to Sars-Cov2 Infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuseppe Banfi	IRCCS Orthopedic Institute Galeazzi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Ortopedico Galeazzi		Milan		20161	Italy

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

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Not provided

Browse Branches

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