Israel starts clinical trial of plasma-derived Covid drug
August 28, 2020
Physicians at Hadassah University Medical Center in Jerusalem report promising early results of a clinical study in which they are treating Covid-19 patients with immunoglobulin derived from the plasma of recovered patients found to have high levels of antibodies.
The serum is prepared by Rehovot-based biopharmaceutical company Kamada.
Three patients have already received the serum and are doing well, according to Dr. Yaron Ilan, chief of internal medicine at Hadassah University Medical Center. "The first patient demonstrated a rapid clinical benefit and went home after previously being in moderate condition."
The other two also have been released from the hospital.
Ilan stressed that this experimental treatment, though very encouraging, is in an early phase.
Dr. Zeev Rotstein, director general of Hadassah Medical Center, called their recovery "almost a miracle."
Rotstein was among the initiators of the collection of plasma from recovered corona patients. He also revealed to the Jerusalem Post on August 12 that Hadassah will help test a Russian-developed vaccine for coronavirus.
For the past three months, Hadassah has been collecting plasma donations from recovered patients with the cooperation of ultra-Orthodox communal organizations.
Kamada said additional Israeli hospitals are taking part in this Phase 1/2 clinical trial of the anti-SARS-CoV-2 plasma-derived IgG.
"This open-label, single-arm multicenter study was approved by the Ministry of Health in Israel. The trial will assess the safety, pharmacokinetics and pharmacodynamics of the company's plasma-derived IgG product in hospitalized, non-ventilated Covid-19 patients with pneumonia," Kamada reported.
"A total of 12 eligible patients will be enrolled and receive Kamada's product at a single dose of 4g within 10 days of initial symptoms. Patients will be followed for 84 days. In parallel, Kamada intends to further explore the potential of its IgG product to prevent Covid-19 disease in healthy subjects at risk in a separate study."
This milestone is part of the global collaboration agreement established in April 2020 between Kamada and its partner Kedrion Biopharma for the development, manufacturing and distribution of a plasma-derived immunoglobulin product as a potential treatment for coronavirus disease.
Kamada and Kedrion intend to conduct a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration soon in anticipation of obtaining FDA approval of the proposed clinical development program. Meanwhile, Kedrion will collect Covid-19 convalescent plasma from recovered American patients.
"We are encouraged by the results of the product neutralization activity and we believe our product has the potential to be an effective treatment for hospitalized, non-ventilated COVID-19 patients with pneumonia, and look forward to the results from this trial," said Amir London, Kamada's CEO.