Grifols will be one new clinical trial in Spain to evaluate the safety and efficacy of a new drug, that is based on the immunoglobulin Gamunex-C and contains polyclonal anti-SARS-CoV-2 antibodies obtained from plasma donors who have overcome the disease. The drug would be one protection with immediate effect after exposure to the virus that it would be especially helpful as a supplement to the vaccine early after vaccination, the blood products company reported Monday. The test, which will start in February and the results are expected in the spring, is lconceived by researchers Oriol Mitjà and Bonaventura Clotet, from the Germans Trias i Pujol Hospital in Badalona (Barcelona).
In the process About 800 asymptomatic and SARS-CoV-2 positive individuals will participate in diagnostic tests, to whom Grifols immunoglobulin rich in antibodies against the virus will be administered subcutaneously. The immunoglobulin from Grifols, Gamunex-C, in its form for intravenous, intramuscular or subcutaneous administration “has demonstrated safety and efficacy in the prevention of various infectious diseases“in immunocompromised patients and has been used for this purpose for over 15 years.
The medicine “could protect “the elderly and health workers, as well as immunocompromised patients in whom vaccination is not recommended, and would help to limit outbreaks where vaccination has not started or has not been completed. Mitjà has indicated that this treatment with immunoglobulins as a basis “would yield a combination of polyclonal antibodies that exhibit greater diversity compared to monoclonal antibodies that could improve your ability to protect you from the virus. “
Easy to preserve
Grifols’ medical director, Dr. Antonio Páez, emphasized that “the convenience of refrigerator storage and subcutaneous administration” they would promote the distribution and use of this potential therapy, which could be administered in any medical office, and avoid a visit to a hospital. “If its effectiveness is confirmed, the new therapy could be given to people who have tested positive for antigens and PCR in hospitals and primary health networks, ”he added.
In October 2020 Grifols initiated the Itac clinical trial along with other companies and several US health agencies to test the efficacy and safety of hyperimmune anti-SARS-CoV-2 immunoglobulin in hospitalized and critically ill patients, with results expected in the first half of 2021.