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Completed

NCT Number: NCT04407169

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

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.

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Key information

Conditions

COVID

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Valentin Simon

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

There will be no intervention. It is only an observationnal study

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms

Acronym: CRITICoVid

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 29, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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