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

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Status and phase: Withdrawn; Phase 3

Conditions: Covid19; Pneumonia, Viral

Treatments: Drug: alpha1-proteinase inhibitor; Drug: Antiviral Agents

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04675086

CCR-2020-103188

Details and patient eligibility

About

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.

Full 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.

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Aralast NP + Antiviral Treatment + Standard of Care

Experimental group

Description:

The investigational product is alpha1-proteinase inhibitor, administered as a loading dose of 120mg/kg/body weight intravenous infusion on the first day, and then 60mg/kg/BW intravenous infusion on Days 3, 5, 7 and 9. Booster infusion of 120 mg/kg/BWon Day 17. The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes Standard of Care treatments are at the investigator's discretion based on best practices.

Treatment:

Drug: Antiviral Agents

Drug: alpha1-proteinase inhibitor

Antiviral Treatment + Standard of Care

Active Comparator group

Description:

The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes Standard of Care treatments are at the investigator's discretion based on best practices.

Treatment:

Drug: Antiviral Agents