Developement and Evaluation of Serological Assays for COVID-19

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04377763

Acronym

SEROCOV

Enrollment

500

Registered

2020-05-06

Start date

2020-07-15

Completion date

2021-03-31

Last updated

2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, serological assay

Brief summary

The primary objective of the study aims to evaluate serological assays of virus Covid-19.

Detailed description

This is a retrospective monocentric study, which will include the patients who have hospitalized in Ambroise Paré Hospital and have sampling sent to the Laboratory of Microbiology of the hospital between the 15 March 2020 and 30 september 2020.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient ≥ 18 years; * Have molecular diagnosis of positive or negative result in Covid-19 virus by the Laboratory of Microbiology in Ambroise Paré Hospital; * Have diagnosed of a viral infection in respiratory.

Exclusion criteria

\- Patient refusal.

Design outcomes

Primary

Measure	Time frame	Description
Sensibility and specificity	Throughout of the study, an average of 6 months	Determination of sensibility and specificity of serological testing in SARS-CoV-2 virus in patients with acute respiratory symptoms.

Secondary

Measure	Time frame	Description
Delay between the first symptoms and the positive serological result	Throughout of the study, an average of 6 months	Delay between the first symptoms and the positive serological result of SARS-CoV-2 virus.

Countries

France

Contacts

Primary ContactMarie-Anne RAMEIX-WELTI, MD, PhD

marie-anne.welti@aphp.fr+33 (0)6 65 13 64 34

Outcome results