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

NCT04384731 | Unknown Phase 2 DMC

• 1 other identifier: P20/06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

  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.

Study Arms (2)

Surfactant arm

EXPERIMENTAL

patient receiving the surfactant

Drug: poractant alfa

Control arm

NO INTERVENTION

patient not receiving the surfactant

Interventions

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.

Surfactant arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Christophe LENCLUD: lead

Study Sites (1)

CH Francois Quesnay

Mantes-la-Jolie, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Interventions

poractant alfa

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Christophe LENCLUD, MD

  Hospital of Mantes-la-Jolie, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine ROUX

CONTACT

+33139239777; sroux@ch-versailles.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: May 29, 2020
• Primary Completion: May 29, 2021
• Study Completion: July 31, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)