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

Kamada

Status and phase: Completed; Phase 2; Phase 1

Conditions: Covid19; Pneumonia, Viral

Treatments: Biological: Kamada Anti-SARS-CoV-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04550325

Kamada Anti-SARS-CoV-2-001

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Immune gamma globulin (IgG)

Experimental group

Description:

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

Treatment:

Biological: Kamada Anti-SARS-CoV-2