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

Phase 1

• Conditions: Patients with Coronavirus Disease (COVID-19); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001953-36-ES
• Lead Sponsor: Instituto Grifols, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-08
• Study Completion: 2021-06-11
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Hospitalized male or female patient = 18 years of age at 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 PCR (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization.
3. COVID-19 illness (symptoms) of any duration, including both of the following:
a) Radiographic infiltrates by imaging (chest X-Ray, CT scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with SpO2 <94% on room air
b) Any One of the following related to COVID-19: i. Ferritin > 400ng/mL, ii. LDH > 300 U/L, iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 mg/L
4. Subject provides informed consent (ICF) prior to initiation of any study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Patients 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 subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known Selective IgA Deficiency with anti-IgA antibodies.
4. A medical condition in which the infusion of additional fluid is contraindicated (e.g., decompensated congestive heart failure or renal failure with fluid overload).
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 patient 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. Patients for whom there is limitation of therapeutic effort such as Do not resuscitate” status Note: If the decision is made not to apply treatments or therapeutic procedures that will provide little benefit for the suffering or agony the patient is experiencing, such a patient would not be appropriate for participation in this study and should be excluded.
9. Currently participating in another interventional clinical trial with investigational medical product or device
10. Patients previously requiring long-term oxygen therapy (home oxygen therapy)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 COVID-19.;Secondary Objective: To compare Prolastin plus SMT versus SMT alone with regard to clinical efficacy as assessed by clinical severity, duration of hospital stay, dependency on oxygen or new need for ventilatory support, or ICU admission, clinical response criteria including National Early Warning Score (NEWS), mortality and clinical status scale through Day 29 in hospitalized subjects with COVID-19.;Primary end point(s): The primary efficacy variable is the proportion of subjects dying or requiring ICU admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15.;Timepoint(s) of evaluation of this end point: Through Day 29