Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19

Overview

Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia

Full Title of Study: “A Phase 1/2 Open Label, Multicenter, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients With Pneumonia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 26, 2020

Interventions

  • Biological: Kamada Anti-SARS-CoV-2
    • Anti-SARS-CoV-2 is a preparation of immune gamma globulin manufactured from convalescent plasma of COVID-19 recovered patients, using Kamada’s proprietary purification methods

Arms, Groups and Cohorts

  • Experimental: Immune gamma globulin (IgG)
    • Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion

Clinical Trial Outcome Measures

Primary Measures

  • Adverse events, serious adverse events, and deaths
    • Time Frame: 14 days
    • Record adverse events, serious adverse events, and deaths
  • Adverse events, serious adverse events, and deaths
    • Time Frame: 28 days
    • Record adverse events, serious adverse events, and deaths

Secondary Measures

  • AUC0-7 of Anti SARS CoV-2 antibodies
    • Time Frame: 7 days
    • Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin
  • Neutralization activity
    • Time Frame: 7 days
    • Evaluate virus neutralization activity of patient’s plasma

Participating in This Clinical Trial

Inclusion Criteria

1. Age ≥ 18 years 2. Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR) 3. Hospitalized for COVID-19 pneumonia 4. Dosing should be within 10 days of symptom start 5. Able and willing to sign informed consent form Exclusion Criteria:

1. History of hypersensitivity to plasma products and/or severe Immunoglobulin A deficiency (< 7 mg/dL) 2. Requirement of high flow oxygen devices, or non-invasive ventilation or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening 3. Cardiovascular instability 4. History of thrombo-embolic events 5. Acute renal failure or creatinine >2 mg/dL or estimated estimated glomerular filtration rate (eGFR) <30 mL/min 6. History of lung transplantation 7. Major surgery (abdominal and chest) within the last 4 weeks 8. Severe chronic background disease, per investigator's judgement for example, Cirrhosis grade C, Dialysis, cardiac insufficiency (NYHA III), pulmonary disease (FEV1<50 percent of predicted) etc. 9. Pregnancy or lactation 10. Treatment with plasma units or immunoglobulin preparations within the last 4 weeks 11. Participation in another pharmaceutical interventional clinical study within 4 weeks from screening

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kamada, Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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