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

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

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

Study Overview

• Status: Completed
• Conditions: Pneumonia, Viral; Covid19
• Intervention / Treatment: Biological: Kamada Anti-SARS-CoV-2

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel, 5822012
    • Wolfson Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Ramat Gan, Israel, 52621
    • Sheba Medical Center Hospital- Tel Hashomer
  • Reẖovot, Israel, 7661041
    • Kaplan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events, serious adverse events, and deaths	Record adverse events, serious adverse events, and deaths	14 days
Adverse events, serious adverse events, and deaths	Record adverse events, serious adverse events, and deaths	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-7 of Anti SARS CoV-2 antibodies	Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin	7 days
Neutralization activity	Evaluate virus neutralization activity of patient's plasma	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hospitalization	Time patient spent in hospital	84 days
Clinical status on the 6 point ordinate scale	Score on the 6 point ordinate scale	84 days

Collaborators and Investigators

• Sponsor: Kamada, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): November 26, 2020

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 13, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; COVID-19; Pneumonia; Pneumonia, Viral
• Other Study ID Numbers: Kamada Anti-SARS-CoV-2-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No