Phase Two clinical trials of the COVID-globulin preparation created on the basis of blood of coronavirus patients have been launched in Moscow with 156 patients participating, the press service of the capital’s Healthcare Department reported.
"In Moscow, Phase Two clinical trials of the unique COVID-globulin preparation begin. The day after the preparation was registered, a permit for clinical trials was obtained. In all, six Moscow hospitals which work with coronavirus patients will participate in this endeavor. It is planned to conduct the second phase together with Rostec and Nacimbio over 2-3 months; 156 COVID-19 patients will participate in it with their informed consent," the press service said.
It was noted that Phase Two placebo-controlled trials involved a study of the preparation’s efficacy and safety. The trials will be conducted in compliance with international standards.
Moscow will become the first city in Russia to use a specific immunoglobulin against the coronavirus infection. The COVID-globulin preparation is based on blood plasma of people who have already had the coronavirus and contains antibodies to it. An administration of the preparation helps prevent a severe course of the disease and assists the human body in fighting the infection while a natural immunity is formed. In order to develop the preparation, the city provided 2.5 tonnes of donor plasma as well as prepared medical centers for Phase Two and Three clinical trials. Moscow medics actively researched the use of donor plasma of coronavirus patients for the production of immunoglobulin.
"Moscow has been stocking up on plasma of the coronavirus patients for over a year already. The main goal of procuring it was transfusion of such plasma to inpatients with moderate and severe forms of the disease. After over a year of its usage the transfusion method has proved its effectiveness - in more than half of the cases after the transfusion the patients were spared the necessity to be switched to an artificial respiratory support with the use of lung ventilators," TASS cited the press service aas saying.
