Pfizer tests anti–COVID-19 drug in Brazilians

The clinical tests of a drug against COVID-19 started being conducted in Brazil. Developed by Pfizer, the research uses molecule PF-07321332, an antiviral of the class of protease inhibitors. According to the pharmaceutical company, the medicine, administered orally, has shown potential to be used against the novel coronavirus.

A total of 29 research centers are participating in the phase-two and -three studies, located in the states of Amazonas, Bahia, Ceará, Pernambuco, Rio Grande do Norte, Mato Grosso, Minas Gerais, Rio Grande do Sul, Santa Catarina, Rio de Janeiro, and São Paulo, in addition to the Federal District. Participants must be 18 years old or older.

The Medical School of the Federal University of Minas Gerais (UFMG) is among them. The treatment, the institution reported, is carried out with two daily doses of the PF-07321332 compound associated with Ritonavir for five consecutive days. Monitoring lasts 24 weeks, with three in-person visits in the first months and the other consultations held by phone.

Stages

The molecule being studied was approved in phase one, which tests security and tolerance in human beings. Considering the results obtained, including those from the pre-clinical phase, with in-vitro trials, Pfizer is now developing three pivotal studies, randomized, double-blind, and controlled by placebo.

The tests, therefore, include three types of patients: those not vaccinated or vaccinated with suspected or diagnosed COVID-19 with low risk of developing a severe state; those not vaccinated with suspected or diagnosed COVID-19 with a high risk for developing a severe state; and those not vaccinated living with people with COVID-19 in the same household.

To be conducted in Brazil, studies must be previously approved by the country’s national drug regulator Anvisa and by the National Commission of Ethics in Research (Conep), in addition to the ethics committees of the participating research centers.