Grifols will start a new clinical trial in Spain to evaluate the safety and efficacy of a new drug, which is based on Gamunex-C immunoglobulin and contains anti-SARS-CoV-2 polyclonal antibodies obtained from plasma donors who have overcome the disease. The drug would provide a protection of the effect immediately after exposure to the virus that it would be especially useful as a supplement to the vaccine in the early stages after vaccination, the blood products company reported Monday. The test, which is scheduled to begin in February and results are expected in the spring, is 1designed by researchers Oriol Mitjà and Bonaventura Clotet, from the German hospital Trias i Pujol in Badalona (Barcelona).
In procces approximately 800 asymptomatic and SARS-CoV-2 positive individuals will participate in diagnostic tests, who will be given subcutaneous Grifols immunoglobulin rich in antibodies against the virus. Immunoglobulin Grifols, Gamunex-C, in its form for intravenous, intramuscular or subcutaneous administration “showed safety and efficacy in preventing various infectious diseases“In immunocompromised patients and has been used for more than 15 years for this purpose.
The medicine “could protect “the elderly and health workers, as well as immunocompromised patients whose vaccination is not recommended and would help to contain outbreaks in places where vaccination has not been started or has not been completed. Mitjà indicated that this immunoglobulin treatment as a basis “would provide a combination of polyclonal antibodies that are more diverse than monoclonal antibodies which could improve the ability to protect against the virus. “
Ease of preservation
Grifols’ medical director, Dr. Antonio Páez, pointed out that “Ease of storage in the refrigerator and subcutaneous administration” would encourage the distribution and use of this potential therapy, which could be administered in any medical office, avoiding a visit to a hospital. “If its effectiveness is confirmed, the new therapy could be given to people who tested positive for antigens and PCR in hospitals and health care networks for primary care, “he added.
In October 2020, Grifols began the Itac clinical trial with other companies and several US health agencies to test the efficacy and safety of hyperimmune anti-SARS-CoV-2 immunoglobulin in hospitalized and seriously ill patients, the results of which will be known in the first half of 2021.