Israel Begins Clinical Trials of Coronavirus Drug Derived from Plasma
Israeli scientists report promising early results from a clinical study in which they treat Covid-19 patients with immunoglobulin (IgG) derived from the plasma of recovered patients who have a high level of antibodies. The serum is produced by the biopharmaceutical company Kamada from Rehovot.
According to Dr. Yaron Ilan, head of the therapeutic department, three patients have already received the serum and are feeling well. "The first patient showed rapid clinical improvement and returned home after being in moderate condition." The other two have also been discharged from the hospital.
Dr. Ilan emphasized that this experimental treatment, while very promising, is still in the early stages of trials.
About the Study
For the past three months, Israeli doctors have been collecting plasma donations from recovered patients.
This open-label, multicenter, randomized study has been approved by the Israeli Ministry of Health. The study will evaluate the safety, pharmacokinetics, and pharmacodynamics of the IgG product derived from plasma in hospitalized, non-ventilated Covid-19 patients with pneumonia.
A total of 12 eligible patients are included in the study and will receive a single dose of 4 g over 10 days after the onset of the first symptoms. Patients will be monitored for 84 days. Concurrently, Kamada intends to further investigate the potential of its IgG product for preventing Covid-19 in healthy at-risk subjects in a separate study.
This milestone is part of a global cooperation agreement signed in April 2020 between Kamada and its partner Kedrion Biopharma to develop, manufacture, and distribute an immunoglobulin product derived from plasma as a potential treatment for coronavirus disease.
Kamada and Kedrion plan to soon conduct an Investigational New Drug (IND) study with the U.S. Food and Drug Administration in anticipation of FDA approval of the proposed clinical development program. Meanwhile, Kedrion will be collecting recovering Covid-19 plasma from recovered American patients.
"We are excited about the results and believe that our product may become an effective treatment for hospitalized, non-ventilated patients with COVID-19 and pneumonia, and we look forward to the results of this study," said Amir London, CEO of the biopharmaceutical company Kamada.