On the evening of April 29th, The Lancet, an international medical journal, published the first randomized, double-blind, placebo-controlled, multi-center clinical trial of COVID-19 antiviral drug Redixivir. Compared with placebo, the antiviral drug Remdesivir did not accelerate the recovery of coronavirus pneumonia-19 or reduce the mortality.
The research method adopted in this study is a randomized, double-blind, placebo-controlled, multi-center clinical trial of a new drug, which is recognized as the clinical study with the highest level of evidence. The published research was conducted by researchers from 25 units, including the National Respiratory Disease Clinical Research Center, the Institute of Clinical Medicine of China-China Friendship Hospital and Peking Union Medical College of China Academy of Medical Sciences.
Professor John Norrie of the University of Edinburgh in the United Kingdom commented in the review article published in The Lancet magazine in the same period: "This study is a double-blind, placebo-controlled, multicenter randomized trial, with good implementation, high compliance and few lost visits."
Remdesivir's first randomized, double-blind, controlled multicenter trial in COVID-19.
The Lancet published a paper entitled "Remdesivir for adult patients with severe COVID-19: a randomized, double-blind, placebo-controlled multicenter trial".
In the context of the global epidemic of COVID-19 virus, this study is the first randomized, double-blind, placebo-controlled multicenter trial of antiviral drug Redixivir in COVID-19. On the evening of April 29th, King Cao, vice president of China-Japan Friendship Hospital, who led the research, said in an interview that Academician Wang Chen participated in the design and implementation of this experiment, and the experimental design was perfect, and the strictest standards were implemented in the research process, so the reliability of the experimental results was the highest.
This study is a randomized, double-blind, controlled trial with 237 adults from Wuhan 10 hospitals in China. These 237 patients were hospitalized from February 6 to March this year 12, and were confirmed by the laboratory as seriously infected adults in COVID-19.
"This study found that although Redcevir is safe and well tolerated, it has no obvious benefit compared with placebo." King Cao said that according to the expected experimental design of this study, when the epidemic situation of coronavirus pneumonia-19 in Wuhan, China is effectively controlled and the number of cases is reduced, or at the suggestion of the data safety supervision committee of this study, the study can be terminated and the data can be analyzed according to the termination criteria set in the research plan.
In this study, from February 6th, 2020 to March 2nd, 200219, * * * recruited 237 adult inpatients with severe coronavirus pneumonia-19. The condition of the study is that the patient must be admitted to the hospital within 12 days after onset, and diagnosed as pneumonia by chest imaging examination, and the blood oxygen saturation is below 94%. Subjects were randomly divided into two groups, and received either raloxivir infusion or placebo infusion once a day for 10 days. In the placebo group, 1 patients dropped out of the study before receiving treatment. At the same time, all patients in the trial received standard treatment, including drugs such as lopinavir _ ritonavir, interferon and corticosteroids.
Preliminary research shows that there is no significant clinical improvement in the treatment of critically ill patients in COVID-19.
Strictly trained researchers use the 6-point clinical status scale to evaluate the time of clinical improvement within 28 days. Clinical improvement is defined as at least two improvements compared with the patient's registration grade score.
The study found that there was no statistically significant difference in clinical improvement time between the two groups. Subgroup analysis is also preset in the scheme, which is not as important as the main end point index, but it also helps to fully understand the curative effect of the drug. Among the patients treated within 10 days after onset, it seems that the patients treated with raloxivir recover faster than those treated with placebo, although there is no statistically significant difference.
The study showed that the mortality rate within 28 days after randomization was similar between the two groups, with the mortality rate of 65,438+04% in the Redixivir group and 65,438+03% in the placebo group. However, the subgroup analysis of this primary end point found that the mortality rate of patients who received the treatment of ladixivir within 10 days after onset was lower, which was 1 1%, while that of the placebo group was 15%, but the difference was not statistically significant.
Similarly, for the duration of invasive mechanical ventilation, the main end point, although there is no statistically significant difference between the two groups, it can still be seen that patients receiving Remdesivir treatment are shorter than those receiving placebo. There was no significant difference in oxygen therapy support time, hospitalization time or discharge or death time between the two groups.
In addition, compared with placebo, Remdesivir treatment did not significantly accelerate the reduction of viral load or reduce the virus detection rate in upper respiratory tract or lower respiratory tract samples.
The author emphasized several limitations of this study, including no significant difference in treatment effect between the two groups, and did not rule out the possibility of a certain treatment effect after expanding the number of cases. In addition, in this study, the use of other antiviral drugs or glucocorticoid may affect the clinical evaluation. Another point is that the experimental drug was used within 12 days after the symptoms appeared, and the activation time was relatively late. If it can be treated at an early stage, it may help to reduce virus replication or slow down the disease.
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