We are reserved and cautious about our preliminary results on amantadine. At present, it is not possible to jump to conclusions. We were mobilized to make them public by the center in Silesia, which has already closed its research – said prof. dr hab. n. med. Konrad Rejdak from SPSK4 in Lublin, conducting clinical trials on the effectiveness of this drug.
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- Prof. Rejdak, the head of the Department of Neurology of the Independent Public Clinical Hospital No. 4 in Lublin and conducting clinical trials on the effectiveness of amantadine in the treatment of patients with COVID-19, said that the preliminary results «indicate a trend towards the effectiveness of the drug in patients enrolled in the study during the five days from confirmation of infection in the absence of significant side effects »
- In an interview with PAP, he admitted that he is distant and cautious about these results, and that all additional parameters obtained during the clinical trial will still be analyzed in detail.
- He noted that the discrepancies at this stage in the results obtained between centers may result from the different treatment of patients included in the clinical trial, as well as the advancement of the COVID-19 disease in them.
- The results of the study in Medonet were commented on by the virologist prof. Szuster-Ciesielska: – Instead of talking about the trend, which raises legitimate public hopes, it would be more correct to say that at present there is no evidence for the effectiveness of amantadine in the treatment of early-stage COVID-19 (more information HERE)
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Klaudia Torchała, PAP: So far, we have the preliminary results of the clinical trials you lead. They concern the study of the effectiveness of amantadine treatment in people suffering from COVID-19. This is the halfway point of this research.
Prof. Konrad Rejdak: Yes, you could say that. The original plan was to recruit about two hundred patients, we have exceeded one hundred.
A dozen or so days earlier, researchers from Silesia informed about their results.
We got a little bit motivated by the publication of these results. Therefore, we have preliminarily analyzed the data we already had, and at the main points of the assessment. In this study, we have a lot of different parameters that we are going to investigate. Now, however, we have focused on the most important ones – the moment of entering and ending the double-blind phase, looking at the trend (participants and staff conducting the study do not know whether the patient is receiving the drug or the placebo – PAP). The patients were monitored continuously for 15 days, so their state of health was changing. We will also want to pay attention to this when preparing the conclusions of the study. We’re going to put it statistically.
What conclusions can already be drawn?
At this point we are talking about the trend and of course – with all distance and caution – we are approaching this data. The data shows no statistically significant differences and therefore no binding conclusions can be drawn at this stage. There was important safety information here. We made sure that the dosing regimen of this drug was not risk-free, because we as neuroscientists have known it for decades. Only use in accordance with the indications and registration doses allows you to avoid the effects that are described in the summary of product characteristics, i.e. as for each drug.
Further part below the video.
You mentioned many parameters that you will take into account and analyze at a later stage of the work. What are these parameters?
These are laboratory tests, chest imaging tests, i.e. tomography and X-rays. We have a whole panel of neurological scales that we’re going to want to compare, so here, of course, we have at least a few of these secondary points in the study. We need some time to compare everything analytically and methodically.
Will it be weeks or months?
It is only a matter of a few weeks at this stage. With the approval of the Medical Research Agency to continue this study, patient enrollment is open.
Does it last until April 15?
Yes. We expect this pandemic wave to slowly fade away. Fortunately, the catastrophic predictions of some experts did not come true. First of all, the nature of the virus changes. It becomes milder, and therefore the course of the disease also changes. We’ve captured the two most dangerous waves of the Delta – last May and the second one from the fall of winter. We covered approximately 500 people with medical care. Only some of them met the criteria for entry into the study, but all received medical advice. This is the added value of the project. We supplemented the care of the National Health Fund by professionally consulting all these patients. In the case of our facility, the cost of research financed by ABM is PLN 6 million. So far, we have used less than half.
What criteria did the patient have to meet to be eligible for the study? Were they also vaccinated against COVID-19, convalescents?
The protocol was written at a time when vaccinations were not yet available, so we could not change it in the process. Even though we promote vaccination, we recognize that many people around the world have not had the chance to get the vaccine. We need new drugs if we get an infection due to a lack of vaccination – in this case, we included patients in the study.
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A total of 93 – of the 110 patients randomized in the study and randomized to receive either drug or placebo – were analyzed?
We enrolled 93 patients for the analysis. In addition, the observations are now being completed by a dozen or so patients, this will also be included in the database. 110 patients were randomized, and at the time of baseline closure 93 patients were followed for at least 15 days and the rest were under follow-up. It was about checking trends. Therefore, these are not final conclusions, but we wanted to refer to the results announced by the center from Silesia, which are based on trends and on a quarter of the target population.
I understand that people in the early stages of infection were taken into the study. Who could actually undergo a clinical trial?
The analyzed group of patients were people who were at risk of severe COVID-19, i.e. were over 40 years old or had comorbidities. In this group, the risk of an unfavorable course of the disease is very high, especially in the Delta variant. Therefore, we are glad that the mortality among the patients under our care turned out to be very low, as it was only 0,93%. generally for the entire study group. It is important to note that it only applied to the subgroup that took placebo (2,3%).
During the clinical trial, patients reported undesirable effects. What?
It is about medical phenomena that did not result directly from the natural course of the disease. Here we noticed an advantage in the number of reports of such phenomena on the side of people taking placebo. It cannot be said that the drug administered in these doses is associated with any dangers. These effects could concern, for example, abnormal heart function, which was not previously registered before COVID-19. It was all carefully noted down. We will analyze it. Now we had too little time.
Where are the discrepancies in the conclusions formulated by the centers as to the effectiveness of the drug, pointing out that the study in Lublin is still ongoing? In Silesia, it was closed with the conclusion that there are no differences between patients treated with amantadine and those using placebo.
These results are different because the analyzed populations are completely different. People eligible for hospital treatment due to COVID-19 were included in Silesia. All of them received remdesivir, a licensed drug, and then either placebo or amantadine were added. Unfortunately, the mortality rate in the entire study group was very high, despite treatment with the standard drug remdesivir. 10 percent died people, which proves the very serious condition of these patients. It was the decision of that research group, which originally was to carry out one project with us, but decided on a different protocol. I understand their decision to suspend their research when they didn’t get any trend lines.
Patients in the study in Lublin did not receive any other preparation apart from amantadine?
Our patients received pre-hospital medical care at the early stage of the disease. They were given either amantadine or a placebo as a supplement, which of course is in line with the general principles of international studies. An innovative aspect of our research is the assessment of nervous system disorders as a complication of COVID-19. At the moment, there are no drugs recommended for this indication. This has been the primary goal of our research from the very beginning. Therefore, we are pleased that the study can continue. I am surprised by the voices of some experts who claim that there is no scientific evidence, but on the other hand that they question the sense of conducting research in accordance with international rules in order to provide this evidence. I see a great contradiction in this.
Interviewed by Klaudia Torchała / PAP
At the same time, we encourage you to listen to the latest episode of the RESET podcast. This time we were talking about breathing. Breathe with your mouth or nose? How To Get Rid Of Bad Breathing Habits? What is breath re-reduction and how does it affect our mental and physical health? You will hear about this and many other aspects of breathing below.
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