NCT04519320

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-05-18
• Primary completion: 2021-08-18
• Completion: 2025-08-18
• First posted: 2020-08-19
• Last updated: 2024-02-23

Locations

1 site across 1 country: France