NCT04678024

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 18, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

December 17, 2020

Last Update Submit

December 22, 2020

Conditions

Covid19

Keywords

test sierologici

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

    Up to 22 weeks

Secondary Outcomes (1)

  • Specificity

    Through study completion, an average of 1 year

Other Outcomes (1)

  • HTA

    Up to 20 weeks

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients or individuals exposed to Sars-Cov2 Infection.

You may qualify if:

  • All patients or individuals exposed to Sars-Cov2 Infection.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Giuseppe Banfi

    IRCCS Orthopedic Institute Galeazzi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 21, 2020

Study Start

November 18, 2020

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

IT(1)