PRESAGE: 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)

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04528901

Collaborator

(none)

1,080

Enrollment

Location

26.9

Anticipated Duration (Months)

40.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19

Study Design

Study Type:

Observational

Anticipated Enrollment :

1080 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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)

Actual Study Start Date :

Sep 4, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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. [15 months]
Carrying out a serological assay of specific antibodies to SARS-CoV-2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

severe persistent asthma (200 patients)
chest cancer that is active or has received treatment within a period of less than one year (300 patients)
history of lung transplantation performed before the start of the epidemic (02/29/2020) (300 patients)
idiopathic or other diffuse interstitial lung disease, sarcoidosis or vasculitis (70 patients)
pulmonary arterial hypertension (PAH) (group 1 of the international classification) any cause or chronic thromboembolic PAH (group 4): (60 patients)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Les Hôpitaux Universitaires de Strasbourg	Strasbourg	Bas-Rhin	France	67091

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator: Céline MASCAUX, CHU de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT04528901

Other Study ID Numbers:

7879

First Posted:

Aug 27, 2020

Last Update Posted:

Jan 27, 2021

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 27, 2021