Developement and Evaluation of Serological Assays for COVID-19

• Conditions: COVID-19

• Registration Number: NCT04377763
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-06
• Study Start: 2020-07-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP; 🇫🇷 Boulogne-Billancourt, France