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: December 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
  • Overall Contact(s)
    • Sharon Castro, MSc, +972 8 9406472, Sharonc@kamada.com

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