Brazil’s Butantan Institute authorized to initiate human trials of anti-Covid serum
RIO DE JANEIRO, BRAZIL – Unlike the vaccine, which is a preventive drug, the serum helps in the treatment of people infected with the disease. With the authorization, the Butantan has the required permission to conduct all clinical trial phases of the serum.
The trials will be conducted at the Kidney Hospital and at the University of São Paulo (USP) School of Medicine’s Clínicas Hospital, both in the city of São Paulo.
Participating volunteers are adults aged over 30 and diagnosed with Covid-19 infection confirmed by PCR within the previous 5 days. The serum is administered intravenously, that is, it is inserted into the vein in a single application. The patient will remain in the hospital for 1 day to be administered the drug.
The trials will be conducted in 2 phases and 3 steps. In phase 1, the trial will involve 30 kidney transplant patients from the Kidney Hospital (stage A); and 30 oncology patients from the Clínicas Hospital with solid organ cancer (stage B). In stage 2, 558 people will be involved, including solid organ transplant recipients and oncology patients, all on immunosuppressive therapy (stage C).
“The focus of the anti-Covid serum in immunosuppressed patients is a contribution from the Butantan to provide treatment to a large public with immunization issues and, in many cases, who cannot take the vaccine. Moreover, these individuals are highly affected by Covid-19, with a mortality rate that can exceed 65%,” the institute highlighted in a statement.
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