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

NCT ID: NCT04519320

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-18
• Study Completion Date: 2025-08-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SARS-COV 2 Patients

Group Type: OTHER

Pulmonary function testing

Intervention Type: 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

Interventions

Pulmonary function testing

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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 .

Exclusion Criteria

• 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
• Subject being in the exclusion period of another study or foreseen by the "national file of the volunteers".

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Besançon

Besançon, Franche-Comté, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 36635717 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35262794 (View on PubMed)

Other Identifiers

2020/499

Identifier Type: -

Identifier Source: org_study_id