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Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease (CRITICoVid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407169
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:

A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known.

The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form.

This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.


Condition or disease Intervention/treatment
COVID Other: no intervention

Study Design
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Study Type : Observational
Actual Enrollment : 617 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : November 17, 2020
Actual Study Completion Date : November 17, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients without chronic respiratory disease
All patients hospitalized for severe CoVid-19 without chronic respiratory disease
 Other: no intervention
There will be no intervention. It is only an observationnal study
Patients with chronic respiratory diseas
Patients hospitalized for severe CoVid-19 with one chronic respiratory disease
 Other: no intervention
There will be no intervention. It is only an observationnal study


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale [ Time Frame: up to 28 days (during hospitalisation) ]
    Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.


Secondary Outcome Measures :
  1. Determined potential predictive factors of critic form in patients with chronic lung diseases [ Time Frame: up to 28 days (during hospitalisation) ]
    Radiological damage (extension of ground-glass) could be a predictive factor.

  2. Determined percentage of death [ Time Frame: up to 28 days (during hospitalisation) ]
    intra-hospital death, intra-ICU death

  3. Determined duration of oxygen therapy [ Time Frame: up to 28 days (during hospitalisation) ]
    in days (or duration at a different flow rate compared to long-term home oxygen therapy prior to hospitalization)

  4. Determined duration of hospitalization [ Time Frame: up to 28 days (during hospitalisation) ]
    in days for patients with chronic respiratory disease between the date of admission and the date of discharge. Patients who died during hospitalization will be assigned the highest cohort value.

  5. Determine mean values of the WHO CoVid-19 infection progression scale measured [ Time Frame: up to 28 days (during hospitalisation) ]
    values will be measured at D3, D7 and D14 in each of the groups. Patients who do not reach D7 and D14 will have the last postponement


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients hospitalized for severe CoVid-19 with or without chronic respiratory disease
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years of age
  • Diagnosis of CoVid-2 SARS infection retained (from clinical presentation, radiological and CoVid-19 positive microbiological specimen).
  • Hospitalisation in the conventional medical sector for "respiratory" reasons (= severe form of CoVid-19) in the Nancy-Brabois hospital and Metz-Thionville Hospital between 02/03/2020 and 15/06/2020.

Exclusion Criteria:

  • Diagnosis of SARS-CoV-2 infection not retained
  • Refusal of the patient to participate in the study
  • Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: o Pregnant woman, parturient or breastfeeding mother o Minors (not emancipated) o Persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) - Persons of full age unable to express their consent Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407169


Locations
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France
Valentin Simon
Vandoeuvre Les Nancy, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
More Information
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Publications of Results:

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04407169    
Other Study ID Numbers: 2020PI081
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases