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

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 group) in Hospitalized Patients with Pneumonia and COVID-19 Infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Blessing Corporate Services, Inc
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: Alpha 1-Antitrypsin; Antiviral Agents; Protease Inhibitors; Remdesivir

Criteria

Inclusion Criteria

1. Subject will sign and date an informed consent form.

2. Hospitalized subjects will be 18 years of age or older.

3. Lab confirmed positive for COVID-19 within 72 hours prior to randomization.

4. 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.

5. 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

1. Subject is on mechanical ventilation at time of screening.

2. Subject is not expected to survive greater than 48 hours from screening based on PI judgement.

3. Prior or current treatment with anti-IL-6, anti-IL-6 R antagonist or JAK inhibitors.

4. Subject is on immunosuppressive agents, with the exception of corticosteroids for severe COVID-19 patients at the discretion of the PI.

5. Subject is currently participating in a trial for any other investigational drug.

6. Subject is on another plasma derived product or has received plasma or blood products within the last 48 hours.

7. Subject is pregnant or breastfeeding.

8. The subject, or the next of kin/power of attorney are not able to give the proper informed consent.

9. The subject has a known IgA deficiency with anti-IgA antibodies.

10. Subject has a known Alpha-1 Antitrypsin Deficiency.

11. Subject has antibodies against alpha-1 proteinase inhibitor

12. Subject has renal, liver or multisystem organ failure

13. Subject has known history of hypersensitivity following infusions of human blood or blood components (eg, human immunoglobulins or human albumin).

14. Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.