Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19 (Caards-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384731
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Christophe LENCLUD, Versailles Hospital

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.


Condition or disease Intervention/treatment Phase
COVID-19 ARDS, Human Drug: poractant alfa Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : January 30, 2021


Arm Intervention/treatment
Experimental: Surfactant arm
patient receiving the surfactant
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.

No Intervention: Control arm
patient not receiving the surfactant



Primary Outcome Measures :
  1. Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1). [ Time Frame: 1 hour post treatment ]

Secondary Outcome Measures :
  1. Oxygenation : PaO2 / FiO2 ratio. [ Time Frame: up to Day 1 and up to Day 7 ]
  2. Oxygenation : area under the PaO2 / FiO2 curve. [ Time Frame: up to Day 1 and up to Day 7 ]
  3. Oxygenation : area under the SpO2 curve. [ Time Frame: up to Hour 1 and up to Hour 24 ]
  4. Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure. [ Time Frame: 1 hour ]
  5. Overall survival rate [ Time Frame: at 28 days, 56 days. ]
  6. Mortality rate at discharge from the intensive care unit. [ Time Frame: through study completion, an average of 6 months. ]
  7. Mortality rate at discharge from the hospital. [ Time Frame: through study completion, an average of 6 months. ]
  8. Number of ventilator-free days [ Time Frame: Day 28, Day 56 ]
  9. Number of prone position sessions. [ Time Frame: up to 56 days ]
  10. Time between inclusion and the last prone position session. [ Time Frame: up to 56 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384731


Contacts
Layout table for location contacts
Contact: Sandrine ROUX +33139239777 sroux@ch-versailles.fr

Locations
Layout table for location information
France
CH Francois Quesnay Recruiting
Mantes la Jolie, France
Contact: Christophe LENCLUD, MD         
Principal Investigator: Chrstophe LENCLUD, MD         
Sponsors and Collaborators
Dr Christophe LENCLUD
Investigators
Layout table for investigator information
Principal Investigator: Christophe LENCLUD, MD Hospital of Mantes-la-Jolie, France
Layout table for additonal information
Responsible Party: Dr Christophe LENCLUD, Principal Investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT04384731    
Other Study ID Numbers: P20/06
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents