Grifols will start one new clinical trial in Spain to evaluate the safety and efficacy of a new drug, which is based on the immunoglobulin Gamunex-C and contains anti-SARS-CoV-2 polyclonal antibodies obtained from plasma donors who have overcome the disease. The drug would provide one protection of immediate effect post-exposure to virus which would be especially useful as a supplement to the vaccine in the early phase after vaccination, the blood product company reported on Monday. The test, the start is scheduled for February and results are expected in the spring, is ldevised by researchers Oriol Mitjà and Bonaventura Clotet, from the Germans Trias i Pujol Hospital in Badalona (Barcelona).
In the rehearsal around 800 asymptomatic and positive individuals with SARS-CoV-2 will take part in a diagnostic test, Who will be given subcutaneously Grifols immunoglobulin rich in antibodies to viruses. Grifols immunoglobulin, Gamunex-C, in its form for intravenous, intramuscular or subcutaneous administration “has shown safety and efficacy in the prevention of various infectious diseases“In immunodeficient patients and has been used for more than 15 years for this purpose.
The medicine “could protect “the elderly and health personnel, as well as in immunodeficient patients vaccination is not recommended, and would help to contain outbreaks in places where vaccination has not been initiated or has not been completed. Media has noted that this treatment with immunoglobulins as a basis “would provide a combination of polyclonal antibodies that, compared to monoclonal ones, present greater diversity which could improve the ability to protect against the virus “.
Ease of conservation
The medical director of Grifols, Dr. Antonio Páez, stressed that “Its ease of storage in the refrigerator and subcutaneous administration” they would favor the distribution and use of this potential therapy, which could be administered in any medical office by avoiding a visit to a hospital. “If its effectiveness is confirmed, the new therapy could be administered to people who had tested positive for antigens and PCR in hospitals and primary care healthcare networks, ”he added.
In October 2020, Grifols initiated the ITAC clinical trial together with other companies and several American health agencies to test the efficacy and safety of anti-SARS-CoV-2 hyperimmune immunoglobulin in hospitalized and severe patients, the results will be known during the first half of 2021.