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

NCT04519320 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-02-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2021-08-18
Completion
2025-08-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519320 on ClinicalTrials.gov