President Trump’s Doctor Asked Regeneron For Compassionate Use of Treatment

Regeneron’s Vice President of Research, Infectious Diseases and Viral Vector Technologies, Greek-American Dr. Christos Kyratsous, spoke to The National Herald about the company’s monoclonal antiviral treatment, which is being administered to President Trump.

TNH: How did the President’s treatment with Regeneron’s antiviral treatment come to be?

Dr. Christos Kyratsous: On Tuesday we announced the first results from the clinical tests of the antibody treatment. They concerned treatment of people who have been diagnosed positive for coronavirus, but are not in the hospital; this is a population for which it is relatively early in the infection’s progress, and so those in this population do not need to be admitted to the hospital. It is essentially the same situation in which President Trump is right now. What we have shown is that, especially with people who have not developed their own antibodies, treatment with these antibodies effectively reduces the viral load within one week, while also reducing the symptoms of the disease. The time it takes for someone to become asymptomatic after the illness drops to about half, from two weeks to about a week.

Like all companies, Regeneron has specific ways of administering these drugs, if someone’s doctor believes it will help them. When a request is made by a doctor, it goes through the Regeneron Compassionate Use Committee and this committee decides whether or not this medicine should be given. This is a specific legal procedure. This was done today -there was a request from the White House and the president's doctors for the administration of the antibodies, it went through the respective committee, and the antibodies were given to President Trump.

TNH: When were you asked to provide the treatment for President Trump?

CK:  Today (Friday).

TNH: How does this treatment work?

CK: These are antiviral antibodies that directly target and neutralize the coronavirus. They are antibodies against the coronavirus. What they do is they block the coronavirus from entering the cells, facilitating the removal of the coronavirus from the body. This is what we announced on Tuesday. It is early, but these results are in the right direction. I want to stress that we are also running clinical trials with the participation of people who are already in hospitals, and in whom the infection is more advanced. We are also conducting clinical research into the preventive effects, in people who have not been diagnosed positive for coronavirus, but are in high-risk groups to catch the coronavirus, such as members of a family where a coronavirus case has been diagnosed.

TNH: What is the protocol for Regeneron’s treatment?

CK: It is an intravenous, single dose treatment.

TNH: What kind of side effects have been reported so far in your clinical studies?

CK: So far these antibodies are safe. We have not seen side effects in individuals who have been given the antibodies so far. The appropriate committees oversee the clinical trials, monitoring the safety of the drugs administered. So far, in the various clinical trials I mentioned earlier, the antibodies have been given to about 2,000 people, and administering the antibodies to patients in various stages of coronavirus infection has been shown to be safe.

TNH: What exactly does compassionate use mean?

CK: There is a specific framework. I emphasize that President Trump is not taking the treatment as part of a clinical trial. So, either a positive or a negative result does not necessarily mean something for the efficacy of the specific drug. To find out if a drug works or not we have to go through clinical trials, usually with the participation of hundreds of people, to figure out if a drug has the effect we want it to. I do not want to call this use in question a "clinical trial;" it is the use of the drug by one person. We hope, of course, that it has the effect that the President’s doctors want, and that clinical trials show in most patients who have been treated with the antibodies. This remains to be seen in the coming days. But we cannot use President Trump’s treatment to draw any conclusions about the use of the drug.

TNH: The use of this treatment on President Trump is a sign of great confidence in your research, but this is also the most prominent coronavirus case in the world, and the most prominent treatment. Therefore, there may be some reservation, some danger at the level of lay public opinion about the drug’s image, depending on the course of President Trump's health.

CK: That is exactly right. It is a rather complicated situation. Therefore, any uses of the drug under such conditions must be contextualized within all parameters. As I said before, in the first clinical trials we showed that this drug has an antiviral effect. It remains to be seen whether this effect will help President Trump.

TNH: In what stage is your research right now?

CK: We currently have several clinical trials going on. Trials of preventive effect with the participation of people who have not been infected with the coronavirus, clinical trials with the participation of people like President Trump, who have just been diagnosed but are not yet hospitalized or in need of hospitalization, and a third set of clinical trials with the participation of people who are already hospitalized and need medical care there. In this category there are different groupings depending on the disease’s progress. The controlled substance is exactly the same, what changes is the dosage. These clinical trials are taking place mainly in the United States, but we have started working with the NHS, the network of UK hospitals, to run an extensive clinical study there.

** Regeneron did not provide further information on the possible administration of the antibodies treatment to other individuals, such as First Lady Melania Trump, under the compassionate use protocol.



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