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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Covid19, Pneumonia, Viral

Intervention / Treatment
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* Biological: Kamada Anti-SARS-CoV-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR) Hospitalized for COVID-19 pneumonia Dosing should be within 10 days of symptom start Able and willing to sign informed consent form Exclusion Criteria: History of hypersensitivity to plasma products and/or severe Immunoglobulin A deficiency (< 7 mg/dL) Requirement of high flow oxygen devices, or non-invasive ventilation or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening Cardiovascular instability History of thrombo-embolic events Acute renal failure or creatinine >2 mg/dL or estimated estimated glomerular filtration rate (eGFR) <30 mL/min History of lung transplantation Major surgery (abdominal and chest) within the last 4 weeks 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. Pregnancy or lactation Treatment with plasma units or immunoglobulin preparations within the last 4 weeks Participation in another pharmaceutical interventional clinical study within 4 weeks from screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A Phase 1/2 Open Label, 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immune gamma globulin (IgG)<br>Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion | Biological: Kamada Anti-SARS-CoV-2<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, serious adverse events, and deaths | Record adverse events, serious adverse events, and deaths | 14 days | 
| Adverse events, serious adverse events, and deaths | Record adverse events, serious adverse events, and deaths | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-7 of Anti SARS CoV-2 antibodies | Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin | 7 days | 
| Neutralization activity | Evaluate virus neutralization activity of patient's plasma | 7 days |