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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495101
• Other study ID #: GC2005
• Secondary ID: 2020-001953-36
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: July 2021
• Source: Grifols Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 10, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Prolastin
Intravenous infusion 120 mg/kg

Drug:
• Standard Medical Treatment
Standard medical treatment per local policies or guidelines

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitario Valle de Hebrón	Barcelona
Spain	Hospital Universitario de Burgos	Burgos	Castilla León
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Gregorio Marañón	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario Príncipe de Asturias	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Dying or Requiring ICU Admission		Up to Day 15
Primary	Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation		Day 15
Secondary	Change from Baseline in National Early Warning Score (NEWS)		Day 1 through Day 29
Secondary	Time to Clinical Response as Assessed by: NEWS = 2 Maintained for 24 hours		Day 1 through Day 29
Secondary	Time to Hospital Discharge		Day 1 through Day 29
Secondary	Duration of ICU Stay		Up to Day 29
Secondary	Duration of Any Oxygen Use		Day 1 through Day 29
Secondary	Duration of Mechanical Ventilation		Up to Day 29
Secondary	Mean Change from Baseline in Ordinal Scale		Day 1 through Day 29
Secondary	Absolute Value Change from Baseline in Ordinal Scale		Day 1 through Day 29
Secondary	Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale		Day 15, Day 29
Secondary	Time to Sustained Normalization of Temperature		Day 1 through Day 29
Secondary	Percentage of Subjects who Sustained Normalization of Temperature		Day 1 through Day 29
Secondary	Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS)		Up to Day 29
Secondary	Length of Time to Clinical Progression		Up to Day 29
Secondary	Mortality Through Day 29		Up to Day 29