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

• ClinicalTrials.gov Identifier: NCT04550325
• Recruitment Status: Completed
• First Posted: September 16, 2020
• Last Update Posted: January 5, 2021
• Sponsor: Kamada, Ltd.
• Information provided by (Responsible Party): Kamada, Ltd.

Tracking Information

• First Submitted Date: September 10, 2020
• First Posted Date: September 16, 2020
• Last Update Posted Date: January 5, 2021
• Actual Study Start Date: August 5, 2020
• Actual Primary Completion Date: November 26, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: 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
• 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: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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

• Covid19
• Pneumonia, Viral

Intervention

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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2020): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 26, 2020
• Actual Primary Completion Date: November 26, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT04550325
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Kamada, Ltd.
• Study Sponsor: Kamada, Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kamada, Ltd.
• Verification Date: January 2021