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

Last updated: May 31, 2023
Sponsor: Chiesi Farmaceutici S.p.A.
Overall Status: Terminated

Phase

2

Condition

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Respiratory Failure

Treatment

CUROSURF® (poractant alfa)

Clinical Study ID

NCT04502433
CLI-050000-04
2020-002632-75
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Participants were eligible to be included in the study if the following criteria apply:

  1. Male or female ≥18 and ≤ 80 years of age
  2. Informed consent for participation in the study (refer to section 15 for detailedinform consent procedure)
  3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) beforerandomisation
  4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio < 150 mmHg
  5. Lung compliance ≤45 ml/cmH20
  6. Intubated and artificially ventilated less than 48 hours before the first poractantalfa administration

Exclusion

Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply:

  1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage andpneumothorax)
  2. Weight < 40kg
  3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate (eGFR) < 30)
  4. Pregnancy
  5. Administration of any nebulized surfactant in the 48 hours before the first poractantalfa administration
  6. Extracorporeal membrane oxygenation (ECMO)

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: CUROSURF® (poractant alfa)
Phase: 2
Study Start date:
January 06, 2021
Estimated Completion Date:
March 17, 2022

Study Description

This was a multicentre, open-label, randomized phase II proof-of-concept study.

The efficacy and safety of poractant alfa was evaluated in terms of ventilatory free days during the 21 days after randomization, in adult patients diagnosed with ARDS due to SARS-COV-19 infection.

Each patient randomized to the study treatment received 3 administrations of Curosurf ® with a 24 hours dosing interval. The assessment collection was up to Day 28, when the evaluation occurred at the Intensive Care Unit (ICU), or by phone call if the patient has already been discharged.

Seventy patients were planned to 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). The control arm population received Standard of Care (SoC). This study was conducted in United Kingdom (UK), United States of America (US), and Italy.

Overall, 13 patients (Curosurf ® group) and 8 patients (control group) were randomised in the study. Due to low recruitment rate the study was terminated early for non-safety reasons.

Curosurf® is a pulmonary surfactant of natural origin which, when delivered endotracheally (ET). Curosurf® is currently approved for marketing as treatment of premature neonates with RDS or at risk of Respiratory Distress Syndrome (RDS). Chiesi Farmaceutici S.p.A (Chiesi) conducted this study with its porcine-derived surfactant, Curosurf® (poractant alfa), to evaluate the efficacy and safety in ventilated adult patients who were critically unwell in intensive care with SARS-COV-19 ARDS.

Connect with a study center

  • Chiesi site # 14

    Bologna, 40138
    Italy

    Site Not Available

  • Chiesi site #13

    Modena, 41124
    Italy

    Site Not Available

  • Chiesi site #4

    London, SW10 9NH
    United Kingdom

    Site Not Available

  • UCLH and UCL 250 Euston Road

    London, NW1 2BU
    United Kingdom

    Site Not Available

  • Chiesi site # 12

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

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