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

Medium and Long Term Follow-up of SARS-COV-2 Infected Patients Treated at Besançon and Dijon Hospitals: Research and Characterization of Pulmonary Sequelae

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sars-CoV2
• Intervention / Treatment: Diagnostic test: Pulmonary function testing

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Franche-Comté
    • Besançon, Franche-Comté, France, 25000
      • CHU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: SARS-COV 2 Patients

Diagnostic test: 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 M24, M36, M48 and M60: D0 + 24, 36, 48, 60 months; Clinical examination; PFT; 6MWT; MOS SF-36 Questionnaire; HADS scale; Other Names: CT Scan; Six minute walk test; Pulmonary Exercise Stress Test; Blood gases; Ventilatory polygraphy; Questionnaires: HADS and MOS SF-36; Blood Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): August 18, 2021
• Study Completion (Estimated): August 18, 2025

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2020/499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No