Acute Respiratory Distress Syndrome Clinical Trial
— FIBRO-COVIDOfficial title:
Incidence, Risk Factors and Prognosis of Pulmonary Fibrosis During Severe COVID-19 Pneumonia
Verified date | December 2023 |
Source | Hôpital Européen Marseille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital Europeen Marseille | Marseille |
Lead Sponsor | Collaborator |
---|---|
Hôpital Européen Marseille |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ventilator-free days | Number of days alive and free from mechanical ventilation | Day 90 | |
Secondary | Day 90 mortality | Mortality at Day 90 | Day 90 | |
Secondary | Day 28 mortality | Mortality at Day 28 | Day 28 | |
Secondary | ICU Mortality | Death from any cause during the ICU stay | From date of ICU admission until the date of ICU liberation, assessed up to 6 months | |
Secondary | In-hospital Mortality | Death from any cause during the Hospital stay | From date of hospital admission until the date of hospital liberation, assessed up to 12 months | |
Secondary | Length of MV | Duration of mechanical ventilation during the ICU stay | From date of ICU admission until the date of ICU liberation, assessed up to 6 months | |
Secondary | Length of ICU stay | Duration of ICU stay | From date of ICU admission until the date of ICU liberation, assessed up to 6 months | |
Secondary | Length of hospital stay | Duration of hospital stay | From date of hospital admission until the date of hospital liberation, assessed up to 12 months | |
Secondary | Time to viral clearance | Time from first symptom to the first negative SARS CoV-2 PCR | From date of first symptom until the date of ICU liberation, assessed up to 6 months | |
Secondary | Corticosteroid dose | Daily corticosteroid dose (methylprednisolone equivalent) | From date of ICU admission until the date of ICU liberation, assessed up to 6 months | |
Secondary | Lung herpesviridae reactivation | Presence on BAL of at least one Herpesviridae (Cytomegalovirus, Epstein-Barr Virus, Herpes simplex virus, Human herpes virus-6) | From date of ICU admission until the date of ICU liberation, assessed up to 6 months | |
Secondary | Blood herpesviridae reactivation | Presence on serum of at least one Herpesviridae (Cytomegalovirus, Epstein-Barr Virus, Herpes simplex virus, Human herpes virus-6) | From date of ICU admission until the date of ICU liberation, assessed up to 6 months |
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