Status:
WITHDRAWN
Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection
Lead Sponsor:
Blessing Corporate Services, Inc
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Covid19
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subject will sign and date an informed consent form.
- Hospitalized subjects will be 18 years of age or older.
- Lab confirmed positive for COVID-19 within 72 hours prior to randomization.
- Subjects with COVID-19 with evidence of pneumonia (diagnosed by a chest x-ray) on supplemental oxygen or non-invasive ventilation with PO2/FiO2 ratio less than 300.
- Subject must have one of the following elevated inflammatory markers: C-reactive protein \>40mg/L; D-Dimers \> 250ng/mL DDU or \>0.5mcg/mL FEU; Ferritin \>400ng/mL; LDH \>300U/L.
- Exclusion Criteria
- Subject is on mechanical ventilation at time of screening.
- Subject is not expected to survive greater than 48 hours from screening based on PI judgement.
- Prior or current treatment with anti-IL-6, anti-IL-6 R antagonist or JAK inhibitors.
- Subject is on immunosuppressive agents, with the exception of corticosteroids for severe COVID-19 patients at the discretion of the PI.
- Subject is currently participating in a trial for any other investigational drug.
- Subject is on another plasma derived product or has received plasma or blood products within the last 48 hours.
- Subject is pregnant or breastfeeding.
- The subject, or the next of kin/power of attorney are not able to give the proper informed consent.
- The subject has a known IgA deficiency with anti-IgA antibodies.
- Subject has a known Alpha-1 Antitrypsin Deficiency.
- Subject has antibodies against alpha-1 proteinase inhibitor
- Subject has renal, liver or multisystem organ failure
- Subject has known history of hypersensitivity following infusions of human blood or blood components (eg, human immunoglobulins or human albumin).
- Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04675086
Start Date
January 1 2021
End Date
December 1 2021
Last Update
December 21 2020
Active Locations (1)
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1
Blessing Corporate Services, Inc
Hannibal, Missouri, United States, 63401