So far, the drug has been tested only on animals, such as hamsters, and has met all of the scientists’ expectations for effectiveness. There is no confirmation on details or dates of testing on humans.
The serum against the coronavirus was produced in partnership with USP (University of São Paulo). Studies conducted by infectologist Esper Kallás and doctor José Medina have shown the ability to decrease viral load and inflammation, in addition to preserving the lung structure.
The request for authorization of the study was sent by Butantan on March 2. Anvisa took 9 days to analyze the clinical research proposal. The rest of the time was used by Butantan to complement technical data that was missing from the original order.
The purpose of evaluating a clinical research proposal is to verify that the study is sufficient to produce reliable data on the safety and efficacy of the drug. This involves the evaluation of the statistical design of the research, the profile of volunteers, the definition of doses to be tested, among other aspects.
Here’s how the process went:
- March 2 – Anvisa received from the Butantan Institute the DDCM (Dossier for Clinical Development of Medicines) of the hyperimmune anti-Sars-CoV-2 serum;
- March 4th – the Agency sent its technical considerations to the Institute on the first request (technical requirement);
- March 10 – Butantan sent the DEEC (Specific Dossier of Clinical Trial), which presents the proposal of how the study will be carried out, how many volunteers will participate and where the studies will be conducted;
- March 13th – Butantan responded to technical requirements;
- March 19th – Anvisa and Butantan held a meeting to evaluate the clinical protocol presented and the Agency sent additional requirements for unanswered questions;
- March 23 – Butantan sent the additional information agreed at a meeting;
- March 24 – Anvisa authorized clinical research, subject to a Term of Commitment to present missing data.
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