Clinical trial NCT04495101: Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Coronavirus disease
Severe acute respiratory syndrome coronavirus 2
SARS-CoV-2
Lead sponsor: Grifols Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2020-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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).

Primary outcomes:
measure: Percentage of Subjects Dying or Requiring ICU Admission
timeFrame: Up to Day 15
measure: Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation
timeFrame: Day 15
Secondary outcomes:
measure: Change from Baseline in National Early Warning Score (NEWS)
timeFrame: Day 1 through Day 29
measure: Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours
timeFrame: Day 1 through Day 29
measure: Time to Hospital Discharge
timeFrame: Day 1 through Day 29
measure: Duration of ICU Stay
timeFrame: Up to Day 29
measure: Duration of Any Oxygen Use
timeFrame: Day 1 through Day 29
measure: Duration of Mechanical Ventilation
timeFrame: Up to Day 29
measure: Mean Change from Baseline in Ordinal Scale
timeFrame: Day 1 through Day 29
measure: Absolute Value Change from Baseline in Ordinal Scale
timeFrame: Day 1 through Day 29
measure: Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale
timeFrame: Day 15, Day 29
measure: Time to Sustained Normalization of Temperature
timeFrame: Day 1 through Day 29
measure: Percentage of Subjects who Sustained Normalization of Temperature
timeFrame: Day 1 through Day 29
measure: Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS)
timeFrame: Up to Day 29
measure: Length of Time to Clinical Progression
timeFrame: Up to Day 29
measure: Mortality Through Day 29
timeFrame: Up to Day 29
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla León
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Valle de Hebrón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Príncipe de Asturias
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References: