Patients with Coronavirus Disease (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Prolastina 1000 mg, polvo y disolvente para solución para perfusión
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Alpha1-Proteinase Inhibitor (Huma
Sponsors
Instituto Grifols, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Assessment of Clinical Severity: Change in NEWS from baseline (Day 1 through Day 29) The NEWS has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness [Alert, Voice, Pain, Unresponsive]). •Time to clinical response: NEWS = 2 maintained for 24 hours, Day 1 through Day 29 •Time to hospital discharge: defined as duration of hospitalization from Day 1 of study •If admitted to ICU post randomization: Duration of ICU stay through Day 29 •Duration of any oxygen use Day 1 through Day 29 •If requiring mechanical ventilation post randomization: Duration mechanical ventilation through Day 29 •Absolute value and mean change from baseline in the Ordinal scale Day 1 through Day 29 The Ordinal scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. •Proportion (percentage) of subjects in each severity category of the 7-point Ordinal scale at Day 15 and Day 29 •Time to sustained normalization of temperature and proportion of patients with normalization of fever at all time points, defined as temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for at least 24 hours •Number of subjects who develop Acute Respiratory Distress Syndrome (ARDS) through Day 29 •Length of time to clinical progression through Day 29 (defined as the time to death, mechanical ventilation, or ICU admission) •Mortality through Day 29;Timepoint(s) of evaluation of this end point: Through D | — |
Countries
Spain
Contacts
Public ContactDepartment of Clinical Trials
Instituto Grifols, S.A.
Outcome results
None listed