Covid19, Pneumonia, Viral
Conditions
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
Interventions
BIOLOGICALKamada 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
Sponsors
Kamada, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events, serious adverse events, and deaths | 14 days | Record adverse events, serious adverse events, and deaths |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-7 of Anti SARS CoV-2 antibodies | 7 days | Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin |
| Neutralization activity | 7 days | Evaluate virus neutralization activity of patient's plasma |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hospitalization | 84 days | Time patient spent in hospital |
| Clinical status on the 6 point ordinate scale | 84 days | Score on the 6 point ordinate scale |
Countries
Israel
Outcome results
None listed