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Clinical Trials in France / NCT04987528
Active, not recruiting Observational

Pulmonary Fibrosis During Severe COVID-19 Pneumonia

NCT04987528 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2020-03-11
Last updated
2026-01-26

Condition(s) studied

Severe Acute Respiratory Syndrome Coronavirus 2Acute Respiratory Distress SyndromePulmonary Fibrosis

Investigational drug(s) / intervention(s)

Aminoterminal type III peptide of procollagenLung computed tomography

Aminoterminal type III peptide of procollagen: Serial Measurement of PIIINP in serum and/or BAL

Lung computed tomography: Screening for the presence of reticulation or bronchiectasia within lung parenchyma

Study summary

The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), an emerging coronavirus, which has already infected 192 million people with a case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have a critical form with organ failure. Among critical patients admitted to intensive care, about 70% of them will require ventilatory assistance by invasive mechanical ventilation (MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severe lung damage resulting from SARS CoV-2 infection is the acute respiratory distress syndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelial cells leading to an activation of endothelium, hypercoagulability and thrombosis of pulmonary capillaries. This results in abnormal ventilation / perfusion ratios and profound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonia lay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist, which both reduce the need of MV and mortality. The risk factors of death in Intensive Care Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer, severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, the death rate is doubled in those with both reduced thoracopulmonary compliance and elevated D-dimer levels. Patients with severe alveolar damage are at risk of progressing towards irreversible pulmonary fibrosis, the incidence of which still remain unknown. The diagnosis of pulmonary fibrosis is based on histology but there are some non-invasive alternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim to assess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 related pneumonia. We will investigate the prognostic impact of fibrosis on mortality and the number of days alive free from MV at Day 90. Finally, we aim to identify risk factors of fibrosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Acute hypoxemic respiratory failure * Positive SARS CoV-2 PCR on nasopharyngeal swab or distal airway sampling * ICU admission during the hospital stay Exclusion Criteria: * Chronic respiratory failure (Oxygen or NIPPV at home) * Patients with "Do Not Resuscitate" order at ICU admission * Admission from an other ICU with a stay \> 2 days * Transfer to an another ICU during the ICU stay

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hopital Europeen Marseille Marseille France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04987528 on ClinicalTrials.gov ↗ ← All trials in France