Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE September 10, 2020
First Posted Date  ICMJE September 16, 2020
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE August 5, 2020
Actual Primary Completion Date November 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 13, 2020)
  • Duration of Hospitalization [ Time Frame: 84 days ]
    Time patient spent in hospital
  • Clinical status on the 6 point ordinate scale [ Time Frame: 84 days ]
    Score on the 6 point ordinate scale
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Covid19
  • Pneumonia, Viral
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Immune gamma globulin (IgG)
Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion
Intervention: Biological: Kamada Anti-SARS-CoV-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 26, 2020
Actual Primary Completion Date November 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04550325
Other Study ID Numbers  ICMJE Kamada Anti-SARS-CoV-2-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kamada, Ltd.
Study Sponsor  ICMJE Kamada, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kamada, Ltd.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP