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Safety, 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
Kamada, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
September 10, 2020
Last Updated
January 4, 2021
Sponsor
Kamada, Ltd.
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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

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

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