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Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to understand the failure of previous clinical trials and yielded a strong scientific rationale for SRT success, now allowing to design a new administration protocol for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS patients.
Patients will be randomized to receive either a bronchial fibroscopy alone (with aspiration of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a solution of poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar bronchi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant arm | Experimental | patient receiving the surfactant |
|
| Control arm | No Intervention | patient not receiving the surfactant |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| poractant alfa | Drug | Patient receiving surfactant (3 mL/kg of a poractant alpha solution diluted to 16 mg/mL, resulting in a total dose of 48mg/kg) administred by bronchial fibroscopy. The total volume will be divided in each of the five lobar bronchi. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1). | 1 hour post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation : PaO2 / FiO2 ratio. | up to Day 1 and up to Day 7 | |
| Oxygenation : area under the PaO2 / FiO2 curve. | up to Day 1 and up to Day 7 | |
| Oxygenation : area under the SpO2 curve. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine ROUX | Contact | +33139239777 | sroux@ch-versailles.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe LENCLUD, MD | Hospital of Mantes-la-Jolie, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Francois Quesnay | Recruiting | Mantes-la-Jolie | France |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C068291 | poractant alfa |
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| up to Hour 1 and up to Hour 24 |
| Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure. | 1 hour |
| Overall survival rate | at 28 days, 56 days. |
| Mortality rate at discharge from the intensive care unit. | through study completion, an average of 6 months. |
| Mortality rate at discharge from the hospital. | through study completion, an average of 6 months. |
| Number of ventilator-free days | Day 28, Day 56 |
| Number of prone position sessions. | up to 56 days |
| Time between inclusion and the last prone position session. | up to 56 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |