The National Institute of Infectious Diseases Evandro Chagas (INI/Fiocruz) reported that the Pfizer laboratory decided to suspend clinical studies to test the effectiveness of the drug Paxlovid for the treatment of patients at low risk of progressing to more severe Covid-19, that is, people without comorbidities and under 65 years of age.
On June 14, Fiocruz announced the search for volunteers to test the drug.
According to the INI, preliminary analysis of the ongoing study showed no significant decrease in symptom and length of stay among the low-risk patients who participated in the study. The research, which was in the second phase of three, involved several research centers around the world.
In Brazil, the study was carried out in Rio de Janeiro by the Institute and continued in the phase of summoning and selecting volunteers for clinical research. Participants were people over 18 years of age, who had symptoms and a confirmed test for Covid-19 within five days.
In a note to the institution of Fiocruz, the Pfizer laboratory stated that previous studies carried out with the same drug proved to be safe and effective in the treatment of patients at high risk for the development of more severe conditions of the disease. According to the document, the drug remains efficient for those who have adopted this type of procedure.
Paxlovid was previously tested in high-risk patients, which allowed its emergency use to be cleared by regulatory agencies such as the FDA (USA) and the National Health Surveillance Agency (Anvisa).
The results showed that the drug, which combines the antivirals Nirmatrelvir and Ritonavir, reduced hospitalizations for the disease and deaths by 89% in those patients.
The Pfizer laboratory informed the CNN that the determination to discontinue the study was based on the low rate of hospitalization or death in the standard-risk patient population. However, the company said it will continue to evaluate treatment in populations with high unmet medical need.
Pfizer also reported that one of the research findings was that the self-reported sustained relief of all symptoms for four consecutive days, the clinical parameter used as the study’s primary endpoint, showed no statistically significant difference.
* Under the supervision of Fabiana Lima
Source: CNN Brasil
