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

Completed

• Conditions: COVID
• Interventions: Other: no intervention

• Registration Number: NCT04407169
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Study Start: 2020-06-01
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 617

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic respiratory diseas	no intervention	Patients hospitalized for severe CoVid-19 with one chronic respiratory disease
Patients without chronic respiratory disease	no intervention	All patients hospitalized for severe CoVid-19 without chronic respiratory disease

Primary Outcome Measures

Name	Time	Method
Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale	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

Name	Time	Method
Determined percentage of death	up to 28 days (during hospitalisation)	intra-hospital death, intra-ICU death
Determined potential predictive factors of critic form in patients with chronic lung diseases	up to 28 days (during hospitalisation)	Radiological damage (extension of ground-glass) could be a predictive factor.
Determined duration of hospitalization	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.
Determined duration of oxygen therapy	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)
Determine mean values of the WHO CoVid-19 infection progression scale measured	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

Trial Locations

Locations (1)

Valentin Simon; 🇫🇷 Vandoeuvre Les Nancy, France