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

NCT04550325 | Completed Phase 1

• 1 other identifier: Kamada Anti-SARS-CoV-2-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

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

Conditions

Covid19; Pneumonia, Viral

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• AUC0-7 of Anti SARS CoV-2 antibodies

  7 days

• Neutralization activity

  7 days

Other Outcomes (2)

• Duration of Hospitalization

  84 days

• Clinical status on the 6 point ordinate scale

  84 days

Study Arms (1)

Immune gamma globulin (IgG)

EXPERIMENTAL

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

Interventions

Kamada Anti-SARS-CoV-2 BIOLOGICAL

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

Immune gamma globulin (IgG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kamada, Ltd.: lead

Study Sites (4)

Wolfson Medical Center

Holon, 5822012, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center Hospital- Tel Hashomer

Ramat Gan, 52621, Israel

Location

Kaplan Medical Center

Rehovot, 7661041, Israel

Location

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: August 5, 2020
• Primary Completion: November 26, 2020
• Study Completion: November 26, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

IL (4)