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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550325
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Kamada, Ltd.

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Covid19 Pneumonia, Viral Biological: Kamada Anti-SARS-CoV-2 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2020
Actual Primary Completion Date : November 26, 2020
Actual Study Completion Date : November 26, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Immune gamma globulin (IgG)
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events, serious adverse events, and deaths [ Time Frame: 14 days ]
    Record adverse events, serious adverse events, and deaths

  2. Adverse events, serious adverse events, and deaths [ Time Frame: 28 days ]
    Record adverse events, serious adverse events, and deaths


Secondary Outcome Measures :
  1. 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

  2. Neutralization activity [ Time Frame: 7 days ]
    Evaluate virus neutralization activity of patient's plasma


Other Outcome Measures:
  1. Duration of Hospitalization [ Time Frame: 84 days ]
    Time patient spent in hospital

  2. Clinical status on the 6 point ordinate scale [ Time Frame: 84 days ]
    Score on the 6 point ordinate scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550325


Locations
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Israel
Wolfson Medical Center
Holon, Israel, 5822012
Hadassah Medical Center
Jerusalem, Israel, 91120
Sheba Medical Center Hospital- Tel Hashomer
Ramat Gan, Israel, 52621
Kaplan Medical Center
Reẖovot, Israel, 7661041
Sponsors and Collaborators
Kamada, Ltd.
More Information
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Responsible Party: Kamada, Ltd.
ClinicalTrials.gov Identifier: NCT04550325    
Other Study ID Numbers: Kamada Anti-SARS-CoV-2-001
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases