October 18, 2021

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Largest COVID-19 drug treatment and clinical trials are about to begin!

https://www.who.int/

[Science] The world’s largest new coronavirus (COVID-19) drug treatment and clinical trials are about to begin!

Largest COVID-19 drug treatment and clinical trials are about to begin!  In order to jointly fight the new coronavirus, R&D teams across industries, disciplines and national borders quickly assembled. Will this large-scale global new coronavirus drug treatment and clinical trials be successful?

After months of downturn, the world’s largest clinical trial of the new coronavirus has finally restarted. A global study led by the World Health Organization, “Solidarity”-“Unity” clinical trial, is a global, randomized controlled clinical trial of adaptive design.

It contains 1 control group and 4 test groups. The patients in the control group received the current standard clinical methods in their country, and the other 4 test groups would use additional drugs in addition to the standard treatments. It will test three new drugs in hospitalized patients with COVID-19 pneumonia: the anticancer drug imatinib, an antibody called infliximab, which is used to treat autoimmune diseases and artesunate (an anti-cancer drug). Malaria drugs). Recently, a researcher published an article on Science titled “A giant trial of COVID-19 treatments is restarting. Here are the drugs it’s betting on”.

Largest COVID-19 drug treatment and clinical trials are about to begin!

John-Arne Røttingen of the Norwegian Institute of Public Health, who is also the chair of the research executive group, said: “These drugs have been shipped to Finland, and Finland is the first country to receive all approvals. I expect that the first batch of patients may be in Recruiting there, other countries may soon join this new phase-‘SolidarityPlus’; more than 40 companies are also getting ethical and regulatory approvals.”

In March 2020, when the initial “Solidarity” operation began, it was the first time: drug testing was conducted in dozens of countries simultaneously during the pandemic. By the end of this year, it had already ruled on four treatments, none of which showed any benefit, and subsequently fell into delays in negotiations and supervision with pharmaceutical companies. Eric Topol, director of the Scripps Research and Translational Institute, said: “Unity is conducting randomized clinical trials again. Virus-infected patients need better treatment, and we cannot be complacent at all.”

Although the research and development of the new coronavirus vaccine has achieved great success, only two drugs have been shown to reduce the mortality of new coronavirus in hospitalized patients. In June 2020, the Recovery trial in the United Kingdom found that dexamethasone, a cheap steroid, reduced the mortality rate of this group of patients by one-third. In February of this year, Recovery researchers announced that toximab, a monoclonal antibody that blocks interleukin-6 receptors, has further reduced mortality. Both of these drugs work by suppressing the excessive immune response of critically ill patients.

These new drugs also target the immune system, not the virus itself. Røttingen explained that for the critically ill patients in Unity, it may be too late for antiviral drugs to take effect. For example, monoclonal antibodies against SARS-CoV-2 are most effective when injected before the development of serious diseases. But Anthony Gordon, an intensive care specialist at Imperial College London, said: “Patients with more severe illness can benefit from additional drugs targeting the immune system. Although dexamethasone suppresses the immune response to a large extent, while toximab It has effectively cut off one particular pathway. We can also block other pathways, which may be different.”

Imatinib is an oral drug used to treat certain leukemias and other types of cancer. It also protects the epithelial cells in the lining of the alveoli. Oxygen enters the blood from the alveoli. A placebo-controlled trial published in June of 400 hospitalized patients with COVID-19 pneumonia in the Netherlands showed that patients who took the drug spent less time on ventilators and were less likely to die. Gordon is a member of another international trial called REMAP-CAP, which also plans to test the drug. He said: “Although the data are not statistically significant, these data are encouraging and enough to encourage us to carry out Larger research.”

Infliximab is a single-infusion antibody that blocks tumor necrosis factor alpha (a key signaling molecule in the immune system) and is used to treat autoimmune diseases such as rheumatoid arthritis and inflammatory bowel sick. Røttingen said: “Some observational data from a large number of patients show that the drug can also prevent the new coronavirus.”

Artesunate, an injectable derivative of artemisinin, is a powerful killer of malaria parasites. In the laboratory study of SARS-CoV-2, artesunate also showed certain antiviral activity. But Unity is testing it because it has another effect: the drug seems to reduce inflammation and counteract the signal that attracts immune cells into the tissue. This can stop the severe immune response of the new coronavirus that causes damage to the lungs.

The revival of “Unity” has a long history. In October 2020, it announced the results of a study of more than 11,000 patients in 400 hospitals, and the results showed that the four treatments had no benefit, thus frustrating people’s hopes and publicity. The four treatments are: HIV combination therapy lopinavir/ritonavir, malaria drug hydroxychloroquine, interferon-β, and Gilead Sciences’ antiviral drug Remdesivir. Remdesivir’s experiment lasted for a while in order to collect more data. It is expected that there will be complete results in the next few weeks, but by the end of January, all experiments have been stopped.

Soon after, an independent expert committee selected the three new drugs. Part of the delay is due to negotiations with manufacturers to ensure that these drugs are available at affordable prices worldwide, if they prove to be effective. Røttingen said: “Regulatory and ethical approvals in participating countries also take time.”

Røttingen once said: “We have clearly seen that people are very willing to work outside the normal system and really speed up the process when the epidemic begins. This does not seem to be the case now. This is understandable, but it also shows this. The process is not suitable for emergencies. We need to establish fast-track systems for the future in all countries.”

(source:internet, reference only)


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