Grifols is set to initiate a clinical trial in Spain to analyse a new Covid-19 drug, which can potentially offer immediate post-exposure protection against the SARS-CoV-2 virus.
An anti-SARS-CoV-2 immunoglobulin, the drug is based on the company’s immunoglobulin Gamunex-C and has anti-SARS-CoV-2 polyclonal antibodies obtained from Covid-19-recovered plasma donors.
Intravenous/intramuscular/subcutaneous administration of Immunoglobulin Gamunex-C is confirmed to be safe and efficacious in preventing various infectious diseases in immunocompromised patients.
Grifols noted that the drug can be utilised as a complement to the vaccine in the early phase after inoculation.
Furthermore, it could provide protection to the elderly, healthcare staff and immunocompromised patients who cannot take the vaccine shots.
The drug can also be used to stop the disease spread in areas where vaccination drives are yet to start or are still progressing.
The clinical trial will assess the safety and efficacy of the drug on approximately 800 asymptomatic Covid-19 patients. They will be given subcutaneous doses of Grifols’ drug.
The company expects to initiate the trial next month. It will be led by Germans Trias i Pujol Hospital, Barcelona researchers Oriol Mitjà and Bonaventura Clotet.
Grifols Medical Director Dr Antonio Páez said that the potential treatment “is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor’s office, avoiding hospitalisation.”
He added: “If the new therapy’s efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices.”
Last October, Grifols had initiated the clinical trial Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) to analyse the efficacy and safety of the anti-SARS-CoV-2 hyperimmune globulin in hospitalised and serious cases.
Results from this trial are anticipated in the first half of this year.