E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute respiratory distress syndrome due to COVID-19 viral pneumonia |
SDRA : syndrome de détresse respiratoire aiguë provoqué par la pneumonie virale COVID-19. |
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E.1.1.1 | Medical condition in easily understood language |
Acute respiratory distress syndrome |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To show that the drug as used in this procedure improves blood oxygenation (PaO2/FiO2). |
Montrer que, chez des patients en SDRA, l’administration endobronchique de surfactant sous fibroscopie, dans un volume de 3 mL/kg, est efficace sur l’amélioration de l’oxygénation et bien tolérée. |
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E.2.2 | Secondary objectives of the trial |
To assess the impact of this procedure on improving the respiratory state and its duration: oxygenation, weaning time from mechanical ventilation, survival. |
Évaluer l’impact de cette procédure sur l’amélioration de l’état respiratoire et sa durée : oxygénation, délai de sevrage de la ventilation mécanique, survie. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At least 18 years and less than 75 years old. Intensive care unit admission. Intubation and mechanical ventilation since less than 72h. Positive end-expiratory pressure ≥ 5 cmH2O. Acute respiratory distress syndrome following Berlin definition. COVID-19 PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial. Compliance of the respiratory system < 50 mL/cmH2O |
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E.4 | Principal exclusion criteria |
Contraindication to prone position. Pregnancy. Weight < 40 kgs Height below 140 cm or above 190 cm. Profuse bronchorrhea Other significant cause than ARDS to the respiratory failure History of pneumonectomy or pulmonary lobectomy Limitation of therapeutics. No arterial line in place. Impossible to give neuromuscular blockers (e.g. drug unavailable). Severe chronic respiratory failure with oxygen at home. Other severe acute or chronic liver failure Patient scheduled for extracorporeal membrane oxygenation. Known hypersensibility to Curosurf. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome: PaO2 / FiO2 ratio increase between before and one hour after procedure. |
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E.5.2 | Secondary end point(s) |
• Evolution of oxygenation and respiratory state (PaO2, PaO2 / FiO2, SaO2, lung compliance, chest x-ray) and its chronology following the procedure. • Number of ventral decubitus sessions and date of the last session. • Withdrawal time from artificial ventilation, expressed in "free days of artificial ventilation". • Survival at 28 days, 56 days, after discharge from the intensive care unit, after discharge from the hospital. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |