Medium and Long Term Follow-up of COVID-19 Infected Patients: Research and Characterization of Pulmonary Sequelae

NCT04519320 | Active Not Recruiting

• 1 other identifier: 2020/499
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of atypical emerging pneumonia. The clinical spectrum varies from an asymptomatic or mild illness to a serious illness with a high risk of mortality. The most severely affected patients (5%) present an acute respiratory distress syndrome (ARDS), requiring assistance with mechanical ventilation in intensive care. In 2003, persistent lung damage was observed in a third of patients in a Singaporean cohort one year after SARS-CoV infection. A Chinese study showed that 27.3% of their SARS-CoV patients presented a decreased carbon monoxide diffusion (DLCO) and 21.5% of pulmonary fibrosis lesions. Due to the very recent emergence of SARS-CoV-2, no data is currently available of long-term outcome of these patients. However, recent publications including short-term CT monitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae. In view of these data, the investigators can fear the occurrence of pulmonary sequelae in patients infected with SARS-CoV-2. It is therefore essential to evaluate the evolution of the respiratory status of the most severe patients who have had a stay in intensive care with respiratory assistance.

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• proportion of patients with an alteration of the capillary alveolus barrier at 12 months of follow-up, characterized by a decreased of the diffusing capacity for carbon monoxide (DLCO) below the lower limit of normal

  DLCO

  12 months after the first symptoms of SARS-COV-2

Study Arms (1)

SARS-COV 2 Patients

OTHER

Diagnostic Test: Pulmonary function testing

Interventions

Pulmonary function testing DIAGNOSTIC_TEST

D0: date of first symptoms of SARS-COV-2 M3: D0 + 3 months * Blood test * Blood gases * Clinical examination * CT Scan * Pulmonary function testing (PFT) * 6-minute walk test (6MWT) * MOS SF-36 Questionnaire * HADS scale * Ventilatory polygraphy M6: D0 + 6 months * Clinical examination * PFT * 6MWT * MOS SF-36 Questionnaire * HADS scale M12: D0 + 12 months * Blood test * Blood gases * Clinical examination * CT Scan (If anomaly found at M3) * PFT * Pulmonary Exercise Stress Test * 6MWT * MOS SF-36 Questionnaire * HADS scale Subsequent follow-up will be performed only in patients with an alteration defined by a DLCO \<LLN and / or an abnormality objectified at CT-Scan attributable to SARS-CoV-2. M24, M36, M48 and M60: D0 + 24, 36, 48, 60 months * Clinical examination * PFT * 6MWT * MOS SF-36 Questionnaire * HADS scale

Also known as: CT Scan, Six minute walk test, Pulmonary Exercise Stress Test, Blood gases, Ventilatory polygraphy, Questionnaires: HADS and MOS SF-36, Blood Test

SARS-COV 2 Patients

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient infected by SARS-CoV-2 (diagnosed by RT-PCR and / or typical CT imaging)
• Patient hospitalized in the intensive care units of Besançon or Dijon hospitals for severe SARS-CoV-2 pneumonia
• Postmenopausal woman for at least 24 months or surgically sterilized, or, for woman of childbearing age, use of an effective method of contraception
• Signature of informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study.
• Affiliation to a French social security system .

You may not qualify if:

• Chronic respiratory failure under long-term oxygen therapy
• Known diffuse invasive pneumonia
• Life expectancy estimated at less than one year by the doctor
• Legal incapacity or limited legal capacity
• History of psychiatric illness, intellectual disability, lack of motivation or other conditions that may limit the understanding of informed consent
• Subject unlikely to cooperate in the study and / or weak cooperation anticipated by the investigator
• Subject without health insurance
• Pregnant and / or lactating woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, Franche-Comté, 25000, France

Location

Related Publications (2)

• Noureddine S, Roux-Claude P, Laurent L, Ritter O, Dolla P, Karaer S, Claude F, Eberst G, Westeel V, Barnig C. Evaluation of long-term sequelae by cardiopulmonary exercise testing 12 months after hospitalization for severe COVID-19. BMC Pulm Med. 2023 Jan 12;23(1):13. doi: 10.1186/s12890-023-02313-x.

  PMID: 36635717 DERIVED

• Eberst G, Claude F, Laurent L, Meurisse A, Roux-Claude P, Barnig C, Vernerey D, Paget-Bailly S, Bouiller K, Chirouze C, Behr J, Grillet F, Ritter O, Karaer S, Pili-Floury S, Winiszewski H, Samain E, Decavel P, Capellier G, Westeel V. Result of one-year, prospective follow-up of intensive care unit survivors after SARS-CoV-2 pneumonia. Ann Intensive Care. 2022 Mar 9;12(1):23. doi: 10.1186/s13613-022-00997-8.

  PMID: 35262794 DERIVED

MeSH Terms

Interventions

Respiratory Function Tests; Tomography, X-Ray Computed; Walk Test; Blood Gas Analysis; Hematologic Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 19, 2020
• Study Start: May 18, 2020
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)