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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495101
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC ( Instituto Grifols, S.A. )

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
COVID-19 Biological: Prolastin Drug: Standard Medical Treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 29, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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 Name: Alpha1-proteinase inhibitor

Drug: Standard Medical Treatment
Standard medical treatment per local policies or guidelines
Other Name: 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 Name: SMT




Primary Outcome Measures :
  1. Percentage of Subjects Dying or Requiring ICU Admission [ Time Frame: Up to Day 15 ]
  2. Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation [ Time Frame: Day 15 ]

Secondary Outcome Measures :
  1. Change from Baseline in National Early Warning Score (NEWS) [ Time Frame: Day 1 through Day 29 ]
  2. Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
  3. Time to Hospital Discharge [ Time Frame: Day 1 through Day 29 ]
  4. Duration of ICU Stay [ Time Frame: Up to Day 29 ]
  5. Duration of Any Oxygen Use [ Time Frame: Day 1 through Day 29 ]
  6. Duration of Mechanical Ventilation [ Time Frame: Up to Day 29 ]
  7. Mean Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  8. Absolute Value Change from Baseline in Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
  9. Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale [ Time Frame: Day 15, Day 29 ]
  10. Time to Sustained Normalization of Temperature [ Time Frame: Day 1 through Day 29 ]
  11. Percentage of Subjects who Sustained Normalization of Temperature [ Time Frame: Day 1 through Day 29 ]
  12. Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: Up to Day 29 ]
  13. Length of Time to Clinical Progression [ Time Frame: Up to Day 29 ]
  14. Mortality Through Day 29 [ Time Frame: Up to Day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495101


Contacts
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Contact: Mireia Torres +34 93 5710500 mireia.torres@grifols.com
Contact: Elsa Mondou, MD 919-316-2079 elsa.mondou@grifols.com

Locations
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Spain
Hospital Germans Trias Recruiting
Badalona, Spain
Contact: Carlos Martinez, MD         
Hospital Clínic Recruiting
Barcelona, Spain
Contact: Joan Ramon Badia, MD         
Hospital Valle de Hebrón Recruiting
Barcelona, Spain
Contact: Marc Miravitlles, MD         
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Contact: Myriam Calle, MD         
Hospital Gregorio Marañón Recruiting
Madrid, Spain
Contact: Puente, MD         
Hospital Príncipe de Asturias Recruiting
Madrid, Spain
Contact: Jose Miguel Rodríguez- Moro, MD         
Sponsors and Collaborators
Instituto Grifols, S.A.
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Responsible Party: Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT04495101    
Other Study ID Numbers: GC2005
2020-001953-36 ( EudraCT Number )
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Grifols Therapeutics LLC ( Instituto Grifols, S.A. ):
Coronavirus disease
Severe acute respiratory syndrome coronavirus 2
SARS-CoV-2
Additional relevant MeSH terms:
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Protease Inhibitors
Alpha 1-Antitrypsin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors