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

Sponsor
Instituto Grifols, S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT04495101
Collaborator
(none)
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: Prolastin
  • Drug: Standard Medical Treatment
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 29, 2020
Actual Primary Completion Date :
Apr 26, 2021
Actual Study Completion Date :
Jun 10, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Biological: Prolastin
Intravenous infusion 120 mg/kg
Other Names:
  • Alpha1-proteinase inhibitor
  • Drug: Standard Medical Treatment
    Standard medical treatment per local policies or guidelines
    Other Names:
  • SMT
  • Active Comparator: Standard Medical Treatment

    Subjects will receive all standard of care interventions while hospitalized, from Day 1 to Day 29.

    Drug: Standard Medical Treatment
    Standard medical treatment per local policies or guidelines
    Other Names:
  • SMT
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Subjects Dying or Requiring ICU Admission [Up to Day 15]

    2. Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation [Day 15]

    Secondary Outcome Measures

    1. Change from Baseline in National Early Warning Score (NEWS) [Day 1 through Day 29]

    2. Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [Day 1 through Day 29]

    3. Time to Hospital Discharge [Day 1 through Day 29]

    4. Duration of ICU Stay [Up to Day 29]

    5. Duration of Any Oxygen Use [Day 1 through Day 29]

    6. Duration of Mechanical Ventilation [Up to Day 29]

    7. Mean Change from Baseline in Ordinal Scale [Day 1 through Day 29]

    8. Absolute Value Change from Baseline in Ordinal Scale [Day 1 through Day 29]

    9. Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale [Day 15, Day 29]

    10. Time to Sustained Normalization of Temperature [Day 1 through Day 29]

    11. Percentage of Subjects who Sustained Normalization of Temperature [Day 1 through Day 29]

    12. Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS) [Up to Day 29]

    13. Length of Time to Clinical Progression [Up to Day 29]

    14. Mortality Through Day 29 [Up to Day 29]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    4. 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

    5. 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),

    1. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L)
    1. 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario de Burgos Burgos Castilla León Spain 09006
    2 Hospital Universitari Germans Trias i Pujol Badalona Spain
    3 Hospital Clínic de Barcelona Barcelona Spain
    4 Hospital Universitario Valle de Hebrón Barcelona Spain
    5 Hospital Clínico San Carlos Madrid Spain
    6 Hospital General Gregorio Marañón Madrid Spain
    7 Hospital Universitario Infanta Leonor Madrid Spain
    8 Hospital Universitario Príncipe de Asturias Madrid Spain
    9 Hospital Universitario Ramón y Cajal Madrid Spain

    Sponsors and Collaborators

    • Instituto Grifols, S.A.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instituto Grifols, S.A.
    ClinicalTrials.gov Identifier:
    NCT04495101
    Other Study ID Numbers:
    • GC2005
    • 2020-001953-36
    First Posted:
    Jul 31, 2020
    Last Update Posted:
    Jul 8, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Instituto Grifols, S.A.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 8, 2021