A pill that can effectively prevent the worst consequences of Covid-1 of may eventually get in the way.
On Friday, pharmaceutical companies Merck and Rizbak Biotherapeutics announced the preliminary results of a large trial of their experimental antiviral drug, called Molnupirvi. The drug subsequently reduced the chances of subsequent hospitalization or death by about 50%Individuals at risk of mild to moderate illness-the results were so dramatically positive that the trial was quickly closed. Companies are now planning to seek emergency use approval for the drug, although the results have not yet been verified by outside scientists.
Molnupiravir is said to work by interfering with a virus The ability to replicate inside a host’s cell, hopefully limits the viral load and enables the immune system to quickly clear the infection, Without the progression of more serious illnesses. The drug was developed before the epidemic as a possible treatment for the flu and other viral diseases.
Step 3 was the purpose of a randomized, double-blind, and controlled trial of Molnupirvi, called MOVe-OUT. About 1,500 vaccinated patients who initially had mild to moderate Covid-1 symptoms but were at higher risk of serious illness due to their existing health. In general, though, the researchers conducted an interim analysis of the trial when only 775 patients were treated. About 14% of those in placebo were hospitalized or died within 30 Days, about 7% of those who took Molnupirvi, no deaths were reported in the medical group compared to eight WHO Died in the placebo group.
Clinical trials could be hastily stopped by an independent board of outside scientists because the treatment seems so impossible that it would be unethical to continue. But they can also be discontinued because the treatment looks so much better than standard care that it would not be right to list participants in a control or placebo. The group and here the independent board agreed. The companies say more than 90% of the trials have already been recruited Although it was officially finished, more data will probably be sought.
“As the virus spreads widely, and as there are currently therapeutic options available and / or access to a healthcare facility, antiviral treatments that can be taken at home to keep infected people with Covid-1 out of the hospital are critically needed,” said Rizbak Biotherapeutics. Hallman said Statement Announcement of results.
Although Molnupirvi has been promising Kovid-1 treatment for some time, there have been some controversies and failures surrounding it.
Last year, federal official and finally whistleblower Rick Bright complained that the Trump administration had retaliated against him for a number of decisions, including Reluctance The issuance of additional funding by him and others to the original founders of medicine at Emory University and the subsequent resurrection for the development of medicine before and during the epidemic. Brilliant argued that the medicine, at the time of the promise, was already there Adequate resources available, And he has expressed those additional concerns Funding will disrupt the normal process of research and development. He further noted that some animal studies had suggested that similar drugs could cause harmful mutations that could be transmitted to children.
In April, Mark and Rizbak also biotherapeutics Off As part of their move-out trial, it was determined that sufficient evidence did not support the use of Molnupirvi for patients already hospitalized. In fairness, this was a common pattern for many antivirals tested during epidemics. And at least partly because the serious illness from Kovid-1 is caused by a destructive immune response, not the infection itself at the time. Moreover, Molnupirvir’s study does not seem to have found evidence of harmful side effects, Bright was at least concerned so far. Drugs suspected of causing mutagenic side effects have been approved in the past, usually with caution against their use while currently pregnant or planning to become pregnant.
Mark and Rizbak now plan to submit the drug immediately for emergency use approval. After that, the Food and Drug Administration and related experts are expected to analyze the safety and testing data and discuss the potential risks and benefits of the drug extensively. If approved by the author, it may not be left alone for a long time. Arrive Their clinical trial is also over. Generic antidepressant Fluoxetine It has also been shown to significantly prevent hospital admissions from Kovid-1 But not yet peer reviewed Judgment