Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital) (PRESAGE)

January 26, 2021 updated by: University Hospital, Strasbourg, France
seroPREvalence vis-à-vis SARS-CoV2 and correlation with clinical forms of COVID-19 in patients followed in Pulmonology in the cluster area of the Grand-Est region.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1080

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
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67091

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

Patient followed in pulmonology at Strasbourg University Hospital

Description

Inclusion Criteria:

  • Man or woman from 18 years old and without upper age limit
  • Patient followed in pulmonology at Strasbourg University Hospital

  • Patient presenting at least one of the following pathologies:

    1. severe persistent asthma (200 patients)
    2. chest cancer that is active or has received treatment within a period of less than one year (300 patients)
    3. history of lung transplantation performed before the start of the epidemic (02/29/2020) (300 patients)
    4. idiopathic or other diffuse interstitial lung disease, sarcoidosis or vasculitis (70 patients)
    5. pulmonary arterial hypertension (PAH) (group 1 of the international classification) any cause or chronic thromboembolic PAH (group 4): (60 patients)
    6. Severe COPD in the respiratory failure stage (150 patients)
  • Subject affiliated to a social health insurance protection scheme
  • Subject able to understand the objectives of the research
  • Subject having signed an informed consent

Exclusion Criteria:

  • Inability to provide informed information about the subject (subject in an emergency situation, difficulty in understanding the subject, etc.)
  • Subject under safeguard of justice
  • Subject under guardianship or guardianship

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine and compare the seroprevalence for SARS-CoV2 among patients with respiratory pathologies monitored in Pneumology at the Strasbourg University Hospital, in the cluster zone of the Grand Est.
Time Frame: 15 months
Carrying out a serological assay of specific antibodies to SARS-CoV-2
15 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Céline MASCAUX, CHU de Strasbourg

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)

September 4, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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