NCT04528901

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 4, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 27, 2021

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

August 25, 2020

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Carrying out a serological assay of specific antibodies to SARS-CoV-2

    15 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient followed in pulmonology at Strasbourg University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, 67091, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Céline MASCAUX

    CHU de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 27, 2020

Study Start

September 4, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 27, 2021

Record last verified: 2020-09

Locations