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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550325
• Other study ID #: Kamada Anti-SARS-CoV-2-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 5, 2020
• Est. completion date: November 26, 2020

Study information

• Verified date: January 2021
• Source: Kamada, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 26, 2020
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Pneumonia
• 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

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Sheba Medical Center Hospital- Tel Hashomer	Ramat Gan
Israel	Kaplan Medical Center	Re?ovot

Sponsors (1)

Lead Sponsor	Collaborator
Kamada, Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of Hospitalization	Time patient spent in hospital	84 days
Other	Clinical status on the 6 point ordinate scale	Score on the 6 point ordinate scale	84 days
Primary	Adverse events, serious adverse events, and deaths	Record adverse events, serious adverse events, and deaths	14 days
Primary	Adverse events, serious adverse events, and deaths	Record adverse events, serious adverse events, and deaths	28 days
Secondary	AUC0-7 of Anti SARS CoV-2 antibodies	Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin	7 days
Secondary	Neutralization activity	Evaluate virus neutralization activity of patient's plasma	7 days