Developement and Evaluation of Serological Assays for COVID-19 (SEROCOV)

February 24, 2021 updated by: Assistance Publique - Hôpitaux de Paris
The primary objective of the study aims to evaluate serological assays of virus Covid-19.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with positive or negative molecular diagnosis of Covid-19, in the Laboratory of Microbiology of Ambroise Paré Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility and specificity
Time Frame: 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.
Throughout of the study, an average of 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marie-Anne RAMEIX-WELTI, MD, PhD, Laboratoire de Microbiologie Hygiène hospitalière, Hôpital Ambroise paré, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20MWI-SEROCOV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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