Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)

NCT04502433 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CLI-050000-042020-002632-75
• Study Type: interventional
• Target: 22
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in hospitalized adult patients diagnosed with SARS-COV-19 acute respiratory distress syndrome (ARDS).

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndrome; ARDS; Adults; Surfactant; Poractant alfa (porcine surfactant, Curosurf®),; Curosurf®; Coronavirus disease (COVID-19); Coronavirus 2019 Disease

Outcome Measures

Primary Outcomes (1)

• Number of Days Alive and Ventilator-free Days

  The number of days alive and ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation over the 21 days following randomisation. Mechanical ventilation was defined as invasive and non-invasive. The patient was defined as free of mechanical ventilation after 12 hours from the suspension of either invasive and non-invasive ventilation. Patients who died or were mechanically ventilated longer than this period were assessed as zero ventilator-free days.

  up to 21 days

Secondary Outcomes (26)

• Percentage of Patients Alive and Free of Respiratory Failure at Day 28

  at Day 28

• Number of Days Alive and Ventilator-Free at Day 28

  at Day 28

• Mortality at Day 21 and Day 28

  at Day 21 and at Day 28

• Number of Days Alive and Free From Invasive Ventilation at Day 21 and Day 28

  Day 21 and Day 28

• Number of Days Alive and Free From Non-Invasive Ventilation at Day 21 and Day 28

  Day 21 and Day 28

Study Arms (2)

Control

NO INTERVENTION

Patients treated with standard-of-care (SoC), as control cohort

Poractant alfa

EXPERIMENTAL

Patients treated with CUROSURF® (poractant alfa), as an add-on to standard-of-care (SoC)

Drug: CUROSURF® (poractant alfa)

Interventions

CUROSURF® (poractant alfa) DRUG

Three administrations with a 24 hours dosing interval. Each endotracheal (ET) administration 1, 2, and 3 consisted of poractant alfa bolus: 30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW, diluted with normal saline up to 2ml /kg LBW.

Poractant alfa

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were eligible to be included in the study if the following criteria apply:
• Male or female ≥18 and ≤ 80 years of age
• Informed consent for participation in the study (refer to section 15 for detailed inform consent procedure)
• Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before randomisation
• Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio \< 150 mmHg
• Lung compliance ≤45 ml/cmH20
• Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration

You may not qualify if:

• Participants were excluded from the study if any of the following criteria apply:
• Any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax)
• Weight \< 40kg
• Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate (eGFR) \< 30)
• Pregnancy
• Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration
• Extracorporeal membrane oxygenation (ECMO)

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (6)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Chiesi site # 14

Bologna, 40138, Italy

Location

Chiesi site #13

Modena, 41124, Italy

Location

UCLH and UCL 250 Euston Road

London, NW1 2BU, United Kingdom

Location

Chiesi site #4

London, SW10 9NH, United Kingdom

Location

Chiesi site # 12

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Interventions

poractant alfa

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Once the impact of the Covid 19 pandemic significantly declined and intubated patients with acute respiratory distress syndrome (ARDS) outcome became rare, the Sponsor considered it unfeasible to maintain efforts to recruit further patients into the study. Thus, due to low recruitment, the study was terminated early for non-safety reasons.

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Study Officials

• Clark Howard, Prof. /MD

  University College, London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Seventy patients will be randomized in the study with a ratio 3:2 (i.e. 42 patients in the poractant alfa arm and 28 in the control arm).

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: January 6, 2021
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: June 23, 2023
• Results First Posted: June 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); IT (2); US (1)