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

NCT04407169 | Completed

• 1 other identifier: 2020PI081
• Study Type: observational
• Target: 617
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Outcome Measures

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

  Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.

  up to 28 days (during hospitalisation)

Secondary Outcomes (5)

• Determined potential predictive factors of critic form in patients with chronic lung diseases

  up to 28 days (during hospitalisation)

• Determined percentage of death

  up to 28 days (during hospitalisation)

• Determined duration of oxygen therapy

  up to 28 days (during hospitalisation)

• Determined duration of hospitalization

  up to 28 days (during hospitalisation)

• Determine mean values of the WHO CoVid-19 infection progression scale measured

  up to 28 days (during hospitalisation)

Study Arms (2)

Patients without chronic respiratory disease

All patients hospitalized for severe CoVid-19 without chronic respiratory disease

Other: no intervention

Patients with chronic respiratory diseas

Patients hospitalized for severe CoVid-19 with one chronic respiratory disease

Other: no intervention

Interventions

no intervention OTHER

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

Patients with chronic respiratory diseas; Patients without chronic respiratory disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients hospitalized for severe CoVid-19 with or without chronic respiratory disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Valentin Simon

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (4)

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 RESULT

• Fang L, Gao P, Bao H, Tang X, Wang B, Feng Y, Cong S, Juan J, Fan J, Lu K, Wang N, Hu Y, Wang L. Chronic obstructive pulmonary disease in China: a nationwide prevalence study. Lancet Respir Med. 2018 Jun;6(6):421-430. doi: 10.1016/S2213-2600(18)30103-6. Epub 2018 Apr 9.

  PMID: 29650407 RESULT

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 RESULT

• Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, Akdis CA, Gao YD. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-1741. doi: 10.1111/all.14238. Epub 2020 Feb 27.

  PMID: 32077115 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 29, 2020
• Study Start: June 1, 2020
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)