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

Phase 1

Completed

• Conditions: Pneumonia, Viral; Covid19
• Interventions: Biological: Kamada Anti-SARS-CoV-2

• Registration Number: NCT04550325
• Lead Sponsor: Kamada, Ltd.

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 available

Study Timeline

• Study Start: 2020-08-05
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-13
• Study First Posted: 2020-09-16
• Primary Completion: 2020-11-26
• Study Completion: 2020-11-26
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immune gamma globulin (IgG)	Kamada Anti-SARS-CoV-2	Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion

Primary Outcome Measures

Name	Time	Method
Adverse events, serious adverse events, and deaths	28 days	Record adverse events, serious adverse events, and deaths

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Wolfson Medical Center; 🇮🇱 Holon, Israel

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Sheba Medical Center Hospital- Tel Hashomer; 🇮🇱 Ramat Gan, Israel

Kaplan Medical Center; 🇮🇱 Reẖovot, Israel