Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19

COVID-19 Clinical Trial

— Caards-1  

Official title:

Randomized Controlled Phase II Trial of Poractant Alfa (Curosurf®) by Fiberoptic Bronchoscopy-directed Endobronchial Administration in Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Viral Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384731
• Other study ID #: P20/06
• Status: Recruiting
• Phase: Phase 2
• Start date: May 29, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: February 2021
• Source: Versailles Hospital
• Contact: Sandrine ROUX
• Phone: +33139239777
• Email: sroux[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2021
• Est. primary completion date: May 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• At least 18 years

• 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

Exclusion Criteria:

• Contraindication to prone position.

• Pregnancy.

• Weight < 40 kg

• height < 140 cm or height > 190 cm.

• Profuse bronchorrhea (at least 1 succion per hour during 3 hours).

• Other significant cause than ARDS to the respiratory failure.

• Decision to limit active therapies.

• No arterial line in place.

• Obesity with weight / height ratio > 1 kg / cm.

• Impossible to give neuromuscular blockers (e.g. drug unavailable owing to global pandemia).

• Severe chronic respiratory failure with oxygen at home.

• Other severe acute or chronic organ faillure (eg severe liver cirrhosis, severe chronic cardiac failure).

• History of pneumonectomy or pulmonary lobectomy.

• Patient scheduled for extracorporeal membrane oxygenation.

• Known hypersensibility to Curosurf.

• Contraindication to bronchial fibroscopy.

• Person under legal protection.

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS, Human
• COVID-19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• poractant alfa
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.

Locations

Country	Name	City	State
France	CH Francois Quesnay	Mantes la Jolie

Sponsors (1)

Lead Sponsor	Collaborator
Dr Christophe LENCLUD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Oxygenation : PaO2 / FiO2 ratio.		up to Day 1 and up to Day 7
Secondary	Oxygenation : area under the PaO2 / FiO2 curve.		up to Day 1 and up to Day 7
Secondary	Oxygenation : area under the SpO2 curve.		up to Hour 1 and up to Hour 24
Secondary	Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure.		1 hour
Secondary	Overall survival rate		at 28 days, 56 days.
Secondary	Mortality rate at discharge from the intensive care unit.		through study completion, an average of 6 months.
Secondary	Mortality rate at discharge from the hospital.		through study completion, an average of 6 months.
Secondary	Number of ventilator-free days		Day 28, Day 56
Secondary	Number of prone position sessions.		up to 56 days
Secondary	Time between inclusion and the last prone position session.		up to 56 days