This is a Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP Infusion Therapy with Antiviral Treatment and standard of care versus Antiviral Treatment and standard of care (control group) in Hospitalized Patients with Pneumonia and COVID-19 Infection.
Approximately 20 subjects in total will be randomized with 1:1 ratio to the high dose of Aralast NP infusion therapy plus antiviral and standard of care versus antiviral therapy and standard of care. Each subject will participate in the study for 24 days and have one safety follow-up phone call at 30 days. Active treatment will last 17 days, subject will be dosed on Days 1, 3, 5, 7, 9 and have a final booster infusion on Day 17. If the subject is discharged from hospital, any remaining infusions and assessments will be conducted via outpatient clinic visit or home health visit. Subjects will have an in-person visit (hospital or clinic) on Day 24 for a CT scan and follow-up assessment. Efficacy will be evaluated by measuring the duration of new non-invasive ventilation or high flow oxygen used. Additional endpoints include clinical status, cytokine levels, oxygen requirements, SOFA scores, risk of coagulopathy, need for Vasopressors, mortality during the treatment period, PK samples, average days spent in the hospital/ICU, and number of days without a fever.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.
a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization
Blessing Corporate Services, Inc
Hannibal, Missouri, United States
Duration of new non-invasive ventilation or high flow oxygen use (measured by days)
Time frame: 365 Days
Clinical status on a 7-point ordinal scale (from 1=death to 7=not hospitalized
Time frame: 1 Year
The percentage change in cytokine levels from screening through day 10, Day 17 and Day 24
Time frame: 10 Days, 17 Days, & 24 Days
The percentage change in oxygen requirements including PEEP and FiO2 from screening through day 10.
Time frame: 10 Days
The percentage of subjects that required mechanical ventilation during the treatment period.
Time frame: 1 Year
The percent of patients with a SOFA score between 0-6 during treatment period.
Time frame: 1 Year
The percent of mortality during the treatment period.
Time frame: 1 Year
Evaluate the need, dosage and duration of vasopressors (number of days and average daily dose).
Time frame: 1 Year
Number of Days fever free (defined by temperature of <100°F (oral) for 24 hours)
Time frame: 1 Year
To evaluate the average number of days in the ICU
Time frame: 1 Year
To evaluate the average number of days in the hospital
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Time frame: 1 Year
To evaluate the number of days with a PO2/FiO2 <300 or other parameters decided on with oxygen
Time frame: 1 Year
The risk of coagulopathy by measuring Prothrombin time & Partial Thromboplastin time
Time frame: 1 Year
The risk of coagulopathy by measuring D-Dimer
Time frame: 1 Year
The risk of coagulopathy by measuring Platelet Counts
Time frame: 1 Year