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

NCT ID: NCT04384731

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-29
• Study Completion Date: 2021-07-31

Brief 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.

Conditions

COVID-19; ARDS, Human

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surfactant arm

patient receiving the surfactant

Group Type: EXPERIMENTAL

poractant alfa

Intervention Type: 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.

Control arm

patient not receiving the surfactant

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Christophe LENCLUD

OTHER

Sponsor Role: lead

Responsible Party

Dr Christophe LENCLUD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christophe LENCLUD, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Mantes-la-Jolie, France

Locations

CH Francois Quesnay

Mantes-la-Jolie, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sandrine ROUX

Role: CONTACT

sroux@ch-versailles.fr

+33139239777

Facility Contacts

Christophe LENCLUD, MD

Role: primary

Other Identifiers

P20/06

Identifier Type: -

Identifier Source: org_study_id