Poractant Alfa - Curosurf and SARS-COV-19 ARDS (Covid-19)
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ClinicalTrials.gov Identifier: NCT04502433 |
Recruitment Status :
Recruiting
First Posted : August 6, 2020
Last Update Posted : January 20, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | August 3, 2020 | ||||
First Posted Date ICMJE | August 6, 2020 | ||||
Last Update Posted Date | January 20, 2021 | ||||
Actual Study Start Date ICMJE | January 6, 2021 | ||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
number of ventilator-free days [ Time Frame: up to 21 days ] The primary outcome variable will be the number of ventilator-free days, defined as the number of days the patient is not receiving mechanical ventilation during the 21 days following randomisation.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Poractant Alfa - Curosurf and SARS-COV-19 ARDS (Covid-19) | ||||
Official Title ICMJE | Multicenter, Open-label, Randomised Trial to Assess the Efficacy and Tolerability of Poractant Alfa(Porcine Surfactant, Curosurf®) in Hospitalized Patients With SARS-COV-19 Acute Respiratory Distress Syndrome (ARDS) | ||||
Brief Summary | The purpose of this Phase II -Proof of Concept study is to evaluate the efficacy and safety of poractant alfa (Curosurf®), administered by endotracheal (ET) instillation in adult hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS) | ||||
Detailed Description | This is a UK multicentre, open-label, randomized phase II proof of concept study. The efficacy and safety of poractant alfa will be evaluated in terms of ventilatory free days during the 21 days after randomization, in adult patients with ARDS due to SARS-COV-19 infection. The same evaluation is planned in a separate cohort of patients under extracorporeal membrane oxygenation (vvECMO) in terms of ECMO free days during the 21 days after randomization. Each patient randomized to the study treatment will receive three administrations of Curosurf ® with a 24 hours dosing interval. The assessment collection will last until day 28 when the evaluation will occur at the ICU, or by phone call if the patient has been discharged before. 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). An additional exploratory cohort of 15 patients in ECMO will be randomised by 3 sites with a ratio 3:2 (i.e. 9 patients in the poractant alfa arm and 6 in the control arm). The control arm population is treated as per Standard of Care (SoC). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 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). An additional exploratory cohort of 15 patients in ECMO will be randomized by 3 sites with a ratio 3:2 (i.e. 9 patients in the poractant alfa arm and 6 in the control arm). Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Acute Respiratory Distress Syndrome | ||||
Intervention ICMJE | Drug: CUROSURF® (poractant alfa)
Three administrations with a 24 hours dosing interval. Each ET administration 1, 2, and 3 will consist of poractant alfa bolus: 30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW. Dilution with normal saline up to 2ml /kg LBW |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
85 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 31, 2021 | ||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Participants are eligible to be included in the study if the following criteria apply:
Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04502433 | ||||
Other Study ID Numbers ICMJE | CLI-050000-04 2020-002632-75 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Chiesi Farmaceutici S.p.A. | ||||
Study Sponsor ICMJE | Chiesi Farmaceutici S.p.A. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Chiesi Farmaceutici S.p.A. | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |