On Wednesday (24), the National Health Surveillance Agency (Anvisa) authorized the performance of more tests with the drug remdesivir, in the treatment against Covid-19. This will be a Phase 3 study with hospitalized patients with severe pneumonia.
The intention of the research is to understand whether the remedy shows efficacy and safety in these patients when administered with tocilizumab and placebo. The clinical protocol indicates that 105 Brazilian patients should be tested.
The request had been made by the company PPD do brasil Suporte a Pesquisa Clínica Ltda. She even submitted the information about the experimental medication. It is worth remembering that Gilead had already shown that the drug can show positive results in a few days against the new coronavirus, in another study revealed earlier this June.
Anvisa establishes that the conduct of any clinical research must be submitted to the approval of the Research Ethics Committees (CEPs) and the National Research Ethics Commission (Conep).
In the case of deadlines after approval, the agency determined that the decision is on behalf of the sponsor of the study.
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