Back to resultsSafety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
Primary Purpose
Covid19, Pneumonia, Viral
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Kamada Anti-SARS-CoV-2
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Wolfson Medical Center
- Hadassah Medical Center
- Sheba Medical Center Hospital- Tel Hashomer
- Kaplan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Immune gamma globulin (IgG)
Arm Description
Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion
Outcomes
Primary Outcome Measures
Adverse events, serious adverse events, and deaths
Record adverse events, serious adverse events, and deaths
Adverse events, serious adverse events, and deaths
Record adverse events, serious adverse events, and deaths
Secondary Outcome Measures
AUC0-7 of Anti SARS CoV-2 antibodies
Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin
Neutralization activity
Evaluate virus neutralization activity of patient's plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04550325
Brief Title
Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
November 26, 2020 (Actual)
Study Completion Date
November 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kamada, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Pneumonia, Viral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immune gamma globulin (IgG)
Arm Type
Experimental
Arm Description
Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion
Intervention Type
Biological
Intervention Name(s)
Kamada Anti-SARS-CoV-2
Intervention Description
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
Primary Outcome Measure Information:
Title
Adverse events, serious adverse events, and deaths
Description
Record adverse events, serious adverse events, and deaths
Time Frame
14 days
Title
Adverse events, serious adverse events, and deaths
Description
Record adverse events, serious adverse events, and deaths
Time Frame
28 days
Secondary Outcome Measure Information:
Title
AUC0-7 of Anti SARS CoV-2 antibodies
Description
Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin
Time Frame
7 days
Title
Neutralization activity
Description
Evaluate virus neutralization activity of patient's plasma
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Duration of Hospitalization
Description
Time patient spent in hospital
Time Frame
84 days
Title
Clinical status on the 6 point ordinate scale
Description
Score on the 6 point ordinate scale
Time Frame
84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Sheba Medical Center Hospital- Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Reẖovot
ZIP/Postal Code
7661041
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
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