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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04519320
Collaborator
(none)
140
Enrollment
1
Location
1
Arm
63
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Pulmonary function testing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Medium and Long Term Follow-up of SARS-COV-2 Infected Patients Treated at Besançon and Dijon Hospitals: Research and Characterization of Pulmonary Sequelae
Actual Study Start Date :
May 18, 2020
Actual Primary Completion Date :
Aug 18, 2021
Anticipated Study Completion Date :
Aug 18, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

      DLCO

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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".

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Besançon Besançon Franche-Comté France 25000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT04519320
    Other Study ID Numbers:
    • 2020/499
    First Posted:
    Aug 19, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 9, 2022