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

Primary Purpose

COVID-19, ARDS, Human

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

poractant alfa

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CH Francois QuesnayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surfactant arm

Control arm

Arm Description

patient receiving the surfactant

patient not receiving the surfactant

Outcomes

Primary Outcome Measures

Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1).

Secondary Outcome Measures

Oxygenation : PaO2 / FiO2 ratio.

Oxygenation : area under the PaO2 / FiO2 curve.

Oxygenation : area under the SpO2 curve.

Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure.

Overall survival rate

Mortality rate at discharge from the intensive care unit.

Mortality rate at discharge from the hospital.

Number of ventilator-free days

Number of prone position sessions.

Time between inclusion and the last prone position session.

Full Information

NCT ID

NCT04384731

First Posted

May 7, 2020

Last Updated

February 2, 2021

Sponsor

Dr Christophe LENCLUD

1. Study Identification

Unique Protocol Identification Number

NCT04384731

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 29, 2020 (Actual)

Primary Completion Date

May 29, 2021 (Anticipated)

Study Completion Date

July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr Christophe LENCLUD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, ARDS, Human

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surfactant arm

Arm Type

Experimental

Arm Description

patient receiving the surfactant

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

patient not receiving the surfactant

Intervention Type

Drug

Intervention Name(s)

poractant alfa

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Oxygenation : PaO2 / FiO2 ratio.

Time Frame

up to Day 1 and up to Day 7

Title

Oxygenation : area under the PaO2 / FiO2 curve.

Time Frame

up to Day 1 and up to Day 7

Title

Oxygenation : area under the SpO2 curve.

Time Frame

up to Hour 1 and up to Hour 24

Title

Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure.

Time Frame

1 hour

Title

Overall survival rate

Time Frame

at 28 days, 56 days.

Title

Mortality rate at discharge from the intensive care unit.

Time Frame

through study completion, an average of 6 months.

Title

Mortality rate at discharge from the hospital.

Time Frame

through study completion, an average of 6 months.

Title

Number of ventilator-free days

Time Frame

Day 28, Day 56

Title

Number of prone position sessions.

Time Frame

up to 56 days

Title

Time between inclusion and the last prone position session.

Time Frame

up to 56 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sandrine ROUX

Phone

+33139239777

sroux@ch-versailles.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe LENCLUD, MD

Organizational Affiliation

Hospital of Mantes-la-Jolie, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

CH Francois Quesnay

City

Mantes la Jolie

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christophe LENCLUD, MD

First Name & Middle Initial & Last Name & Degree

Chrstophe LENCLUD, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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