Pfizer starts drug studies against Covid in Brazil

In October, Pfizer began conducting phase 2 and 3 clinical trials of a potential drug against Covid-19 in Brazil.

It is an antiviral of the protease inhibitor class, an enzyme that the new coronavirus uses to multiply. The drug administered orally showed potential to become an ally in the fight against the new coronavirus.

The drug uses the molecule PF-07321332, which has shown potent in vitro activity against the new coronavirus in pre-clinical stages, carried out in the laboratory. As well as adequate safety and tolerability in phase 1 studies in humans.

In these studies, the drug will be administered with a low dose of ritonavir, an antiretroviral used to treat HIV infection (Human Immunodeficiency Virus).

In the country, there are more than 20 research centers that participate in this study. They are located in the states of Amazonas, Bahia, Ceará, Federal District, Pernambuco, Rio Grande do Norte, Mato Grosso, Minas Gerais, Rio Grande do Sul, Santa Catarina, Rio de Janeiro and São Paulo.

Those interested in taking part in the research must be over 18 years old and, depending on which of the three strands of the studies are eligible, they may or may not already be vaccinated against Covid-19.

Three studies will be carried out. The first is in unvaccinated patients suspected or diagnosed with Covid-19 and at low risk of developing severe disease.

In addition to the study in vaccinated or unvaccinated patients suspected or diagnosed with Covid-19 and at high risk of developing severe disease. There is also a study for unvaccinated people whose household contacts are with Covid-19.

“The first two want to show that the drug is capable of shortening the duration of symptoms. The third is to assess whether using the drug prevents infection. We still do not have treatment for mild cases of the disease that can be taken at home and via oral,” explained José Valdez Madruga, an infectious disease physician and researcher of clinical studies.

In addition to Brazil, other countries participate in phases 2 and 3 of the studies: United States, Hungary, Japan, South Korea, Malaysia, Mexico, Poland, Puerto Rico, Thailand and Turkey.

In March of this year, Pfizer started a phase 1 clinical trial of the antiviral against Covid-19 orally in healthy adults to verify its safety, tolerability and pharmacokinetics. It was performed in the United States.

In Brazil, six drugs have already been approved by Anvisa (National Health Surveillance Agency) for Covid-19.

The Jair Bolsonaro government (no party) has not included in the SUS any of the six drug treatments for Covid-19 approved by the regulatory agency.

To avoid a serious blow to the president’s denial banner, the Ministry of Health is still trying to prevent the overthrow of guidelines pro-“kit Covid”.

The debates are focused on Conitec (National Commission for the Incorporation of Technologies in the Unified Health System), the ministry’s advisory body for the analysis of new therapies and definition of protocols for the public network.