Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immune gamma globulin (IgG) | Experimental | Single dose of 4g Immune gamma globulin (IgG) preparation Kamada Anti-SARS-CoV-2 given as an intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-7 of Anti SARS CoV-2 antibodies | Measurement of the area under the curve of anti SARS CoV-2 immunoglobulin | 7 days |
| Neutralization activity | Evaluate virus neutralization activity of patient's plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization | Time patient spent in hospital | 84 days |
| Clinical status on the 6 point ordinate scale | Score on the 6 point ordinate scale |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson Medical Center | Holon | 5822012 | Israel | |||
| Hadassah Medical Center |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| 7 days |
| 84 days |
| Jerusalem |
| 91120 |
| Israel |
| Sheba Medical Center Hospital- Tel Hashomer | Ramat Gan | 52621 | Israel |
| Kaplan Medical Center | Rehovot | 7661041 | Israel |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |