Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Participants With Coronavirus Disease (COVID-19)

Overview

The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of participants 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 participants with Coronavirus disease 2019 (COVID-19).

Full Title of Study: “A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Alpha1-Proteinase Inhibitor (Prolastin®) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Hospitalized Subjects With COVID-19″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

Interventions

  • Biological: Prolastin
    • Intravenous infusion 120 mg/kg
  • Drug: Standard Medical Treatment
    • SMT

Arms, Groups and Cohorts

  • Experimental: Prolastin 120 mg/kg + Standard Medical Treatment
    • Participants will receive Prolastin, two intravenous infusion (IV) doses of 120 milligram per kilogram (mg/kg), based upon the participant’s body weight, on Day 1 and Day 8. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29.
  • Active Comparator: Standard Medical Treatment
    • Participants will receive all standard of care interventions while hospitalized, from Day 1 to Day 29.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Grifols, S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Mireia Torres, +34 93 5710500, mireia.torres@grifols.com

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