RIO DE JANEIRO, BRAZIL – According to the company, there was a “statistically significant” reduction in severe cases and deaths in non-hospitalized patients who took the drug compared to those given a placebo.
In its global release on the results, the drugmaker detailed that a total of 90% of trial subjects enrolled were from high risk populations of progressing to a severe form of Covid-19, including those with comorbidities such as cancer, diabetes, obesity, and lung disease, among others.
“The trial met the primary outcome, with a 600 milligram (mg) dose of AZD7442 administered by intramuscular (IM) injection reducing the risk of developing severe Covid-19 or death (from any cause) by 50% compared to placebo in outpatients with symptoms of seven days or less.”
The trial recorded few adverse events in the patients’ arms. There were 18 occurrences among 407 who took AZD7442 and 37 in those taking the placebo, out of a total of 415. LAAB was generally well tolerated in the trial, the company emphasized.
TRIAL
According to the statement, the trial was randomized, double-blind, placebo-controlled that evaluated the safety and efficacy of a single 600-mg intramuscular dose of AZD7442 compared with a placebo.
The trial was conducted in 96 countries, including Brazil, the Czech Republic, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Ukraine, the United Kingdom, and the United States of America. In total, it involved 903 subjects, comprising those who received the drug and the placebo.
Subjects were adults 18 years and older who were not hospitalized and had Covid-19 in mild to moderate forms and symptomatic for 7 days or less. Approximately 13% of subjects were aged 65 or older.
TREATMENTS
AstraZeneca is the company producing the Covi-19 vaccine of the same name, manufactured in partnership with Oxford University, and produced in Brazil in partnership with the Oswaldo Cruz Foundation. It has been one of the most widely used vaccines in the Brazilian vaccination campaign.
AstraZeneca’s executive vice president of biopharmaceutical products Mene Pangalos highlighted the relevance of the results achieved.
“These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for using this therapy in the prevention and treatment of Covid-19. Early intervention with our antibody may provide a significant reduction in progression to severe disease, with continued protection for over 6 months.”
The full results of the clinical trial will now be submitted for publication in a medical journal for peer review. AstraZeneca said it will also discuss the data with health authorities.
Last October 5, 2021, the company announced that it had submitted an application to the U.S. Food and Drug Administration (FDA), equivalent to the Brazilian Health Regulatory Agency (ANVISA), for the emergency use authorization of AZD7442 for Covid-19 prophylaxis.