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

NCT04495101 | Completed Phase 2

• 2 other identifiers: GC20052020-001953-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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).

Conditions

COVID-19

Keywords

Coronavirus disease; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects Dying or Requiring ICU Admission

  Up to Day 15

• Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation

  Day 15

Secondary Outcomes (14)

• Change from Baseline in National Early Warning Score (NEWS)

  Day 1 through Day 29

• Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours

  Day 1 through Day 29

• Time to Hospital Discharge

  Day 1 through Day 29

• Duration of ICU Stay

  Up to Day 29

• Duration of Any Oxygen Use

  Day 1 through Day 29

Study Arms (2)

Prolastin 120 mg/kg + Standard Medical Treatment

EXPERIMENTAL

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; Drug: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

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

Drug: Standard Medical Treatment

Interventions

Prolastin BIOLOGICAL

Intravenous infusion 120 mg/kg

Also known as: Alpha1-proteinase inhibitor

Prolastin 120 mg/kg + Standard Medical Treatment

Standard Medical Treatment DRUG

Standard medical treatment per local policies or guidelines

Also known as: SMT

Prolastin 120 mg/kg + Standard Medical Treatment; Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• COVID-19 illness (symptoms) of any duration, including both of the following:
• 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
• 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)
• Subjects provides informed consent prior to the initiation of any study procedures.

You may not qualify if:

• 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 \[eg, 0.21 for room air\]).
• Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
• 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.
• A medical condition in which the infusion of additional fluid is contraindicated.
• 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.
• Known alpha-1 antitrypsin deficiency for which the subject is already receiving alpha1-proteinase inhibitor augmentation therapy.
• 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.
• Subjects for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
• Currently participating in another interventional clinical trial with investigational medical product or device.
• Subjects previously requiring long-term oxygen therapy (home oxygen therapy).

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (9)

Hospital Universitario de Burgos

Burgos, Castille and León, 09006, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitario Valle de Hebrón

Barcelona, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital General Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario Príncipe de Asturias

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

alpha 1-Antitrypsin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Proteins; Alpha-Globulins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: July 29, 2020
• Primary Completion: April 26, 2021
• Study Completion: June 10, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)