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Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495101
Recruitment Status : Completed
First Posted : July 31, 2020
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC ( Instituto Grifols, S.A. )

Tracking Information
First Submitted Date  ICMJE July 28, 2020
First Posted Date  ICMJE July 31, 2020
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE July 29, 2020
Actual Primary Completion Date April 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2020)
  • Percentage of Subjects Dying or Requiring ICU Admission [ Time Frame: Up to Day 15 ]
  • Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation [ Time Frame: Day 15 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
  • Percentage of Participants Dying or Requiring ICU Admission [ Time Frame: Up to Day 15 ]
  • Percentage of Participants Who are Dependent on Invasive Mechanical Ventilation [ Time Frame: Day 15 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2020)
  • Change from Baseline in National Early Warning Score (NEWS) [ Time Frame: Day 1 through Day 29 ]
  • Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
  • Time to Hospital Discharge [ Time Frame: Day 1 through Day 29 ]
  • Duration of ICU Stay [ Time Frame: Up to Day 29 ]
  • Duration of Any Oxygen Use [ Time Frame: Day 1 through Day 29 ]
  • Duration of Mechanical Ventilation [ Time Frame: Up to Day 29 ]
  • Mean Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  • Absolute Value Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  • Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale [ Time Frame: Day 15, Day 29 ]
  • Time to Sustained Normalization of Temperature [ Time Frame: Day 1 through Day 29 ]
  • Percentage of Subjects who Sustained Normalization of Temperature [ Time Frame: Day 1 through Day 29 ]
  • Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Up to Day 29 ]
  • Length of Time to Clinical Progression [ Time Frame: Up to Day 29 ]
  • Mortality Through Day 29 [ Time Frame: Up to Day 29 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
  • Change from Baseline in National Early Warning Score (NEWS) [ Time Frame: Day 1 through Day 29 ]
  • Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
  • Time to Hospital Discharge [ Time Frame: Day 1 through Day 29 ]
  • Duration of ICU Stay [ Time Frame: Up to Day 29 ]
  • Duration of Any Oxygen Use [ Time Frame: Day 1 through Day 29 ]
  • Duration of Mechanical Ventilation [ Time Frame: Up to Day 29 ]
  • Mean Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  • Absolute Value Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  • Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale [ Time Frame: Day 15, Day 29 ]
  • Time to Sustained Normalization of Temperature [ Time Frame: Day 1 through Day 29 ]
  • Percentage of Participants who Sustained Normalization of Temperature [ Time Frame: Day 1 through Day 29 ]
  • Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Up to Day 29 ]
  • Length of Time to Clinical Progression [ Time Frame: Up to Day 29 ]
  • Mortality Through Day 29 [ Time Frame: Up to Day 29 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19
Official Title  ICMJE A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Prolastin Plus Standard Medical Treatment (SMT) Versus SMT Alone in Hospitalized Subjects With COVID-19
Brief Summary The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Prolastin
    Intravenous infusion 120 mg/kg
    Other Name: Alpha1-proteinase inhibitor
  • Drug: Standard Medical Treatment
    Standard medical treatment per local policies or guidelines
    Other Name: SMT
Study Arms  ICMJE
  • Experimental: Prolastin 120 mg/kg + Standard Medical Treatment
    Subjects will receive Prolastin, two intravenous infusion (IV) doses of 120 milligram per kilogram (mg/kg), based upon the subject's body weight, on Day 1 and Day 8. Subjects will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29.
    Interventions:
    • Biological: Prolastin
    • Drug: Standard Medical Treatment
  • Active Comparator: Standard Medical Treatment
    Subjects will receive all standard of care interventions while hospitalized, from Day 1 to Day 29.
    Intervention: Drug: Standard Medical Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 10, 2021
Actual Primary Completion Date April 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Hospitalized male or female subject ≥ 18 years of age at the time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (≤ 48 hours) of hospital admission.
  2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR) or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
  3. COVID-19 illness (symptoms) of any duration, including both of the following:

    1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT) scan, etc.) and/or clinical assessment (evidence of rales/crackles on the exam) with peripheral oxygen saturation by pulse oximetry (SpO2) <94% on room air
    2. Any One of the following related to COVID-19: i. Ferritin > 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L)
  4. Subjects provides informed consent prior to the initiation of any study procedures.

Exclusion Criteria:

  1. Subjects requiring invasive mechanical ventilation or ICU admission or with PaO2/FIO2 ≤ 150 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration [eg, 0.21 for room air]).
  2. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
  3. The subjects have had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
  4. A medical condition in which the infusion of additional fluid is contraindicated.
  5. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal Investigator.
  6. Known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy.
  7. Women who are pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.
  8. Subjects for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
  9. Currently participating in another interventional clinical trial with investigational medical product or device.
  10. Subjects previously requiring long-term oxygen therapy (home oxygen therapy).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04495101
Other Study ID Numbers  ICMJE GC2005
2020-001953-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Grifols Therapeutics LLC ( Instituto Grifols, S.A. )
Study Sponsor  ICMJE Instituto Grifols, S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Grifols Therapeutics LLC
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP