Further research on amantadine. “Efficiency messages are harmful”

Preliminary results “indicate a trend towards efficacy” of amantadine, says Prof. Konrad Rejdak, presenting the early results of his clinical trial. – Instead of talking about the trend, which raises the legitimate hopes of the public, 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 – virologist Prof. Szuster-Ciesielska.

1. On February 21, prof. Konrad Rejdak, who conducts the research project “The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-COV-2 virus”, presented the preliminary results of the clinical trial
2. As the professor pointed out, they indicate “a trend towards drug efficacy in patients enrolled in the study within five days of confirmation of coronavirus infection in the absence of significant side effects”
3. The press releases about preliminary results suggesting a positive effect of amantadine (even as a trend) are unfortunately harmful – says Prof. Szuster-Ciesielska, explaining that “they arouse hopes and result in the fact that people heal themselves with an untested preparation”
4. «Partial results of the study conducted by the team of prof. dr hab. Konrad Rejdak, MD from Lublin, do not allow conclusions to be drawn as to the alleged effectiveness of amantadine in the treatment of COVID-19. At this stage, making any claims as to the action of amantadine is completely unlawful »- comments the President of the Medical Research Agency, Dr. hab. n. med. Radosław Sierpiński
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Amantadine in COVID inpatient treatment is ineffective. Medical University of Silesia is finalizing the research

On February 11, prof. Adam Barczyk from the Medical University of Silesia presented the first results of clinical trials on the use of amantadine in the treatment of patients with COVID-19. “In the treatment of early stage patients with moderate or severe covid in the hospital, there is no difference between the use of placebo and amantadine,” the researcher announced. Also, the Patient Rights Ombudsman, Bartłomiej Chmielowiec, said that in the light of the latest information, there is no scientific evidence to support the effectiveness of amantadine treatment in COVID-19 patients.

As reported by prof. Barczyk, the study was conducted in a population of patients with hospital COVID-19, «in the early stage of patients with moderate or severe covid, i.e. those who are at the beginning of the disease but have been hospitalized because pneumonia begins, desaturation and hypoxia appear in blood”. There were 163 patients randomized (i.e. the allocation of the patient to the drug group and the placebo group is randomized – ed.).

The rest of the text is below the video.

«As some of the patients did not agree to continue the study or withdrew their consent, the analysis from the randomized group concerns 149 patients, 78 received amantadine and 71 placebo. The study was double-blind (neither the doctors nor the patients know who is receiving the given preparation – editor’s note), until then we did not know what the results were “- said Adam Barczyk, also informing that he turned to the President of the Agency Medical Research to stop recruiting patients and end the study. More on Silesian research on amantadine.

Research in Lublin. Prof. Rejdak: We see a tendency in favor of amantadine

Clinical trials of amantadine are still conducted by the Independent Public Clinical Hospital No. 4 in Lublin. The work on the project “The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-COV-2 virus” is headed by prof. dr hab. Konrad Rejdak, MD, PhD, head of the Department of Neurology of the above-mentioned hospital. On February 21, the scientist presented the preliminary results of the research. “The conclusions are not tantamount to the results of the study of the drug carried out in Silesia so far” – noted prof. Rejdak.

It is worth remembering that research in Lublin is conducted on a different group of patients. The participants are patients infected with the SARS-CoV-2 virus and burdened with risk factors for the severe course of COVID-19 (age and comorbidities). In them, amantadine or placebo are added to standard medical care no later than on the fifth day after confirmation of SARS-COV-2 virus infection by laboratory tests. 110 patients were enrolled and randomized into the study. Initial safety and efficacy analysis was performed on 93 clinical trial participants in both groups (placebo vs amantadine) who completed 15 days of follow-up.

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«There was a trend towards the efficacy of amantadine with a higher percentage of asymptomatic patients on day 15 (62 proc. amantadyna vs. 52 proc. placebo) and severe complications and death (amantadyna 0 proc. vs. placebo 4,6 proc.). There were 41 reports of adverse effects in the safety analysis (17 in the amantadine group and 24 in the placebo group). 10 reports were classified as moderately severe (4 in the amantadine group and 6 in the placebo group) and 1 as severe (0 in the amantadine group and 1 as death in the placebo group) »- we read on the website of the Lublin hospital. The facility emphasizes that the study is continuing to assess the effect of amantadine on the occurrence of delayed complications of COVID-19 (the so-called post-COVID-19 syndrome).

«These are preliminary results. Safety and therapeutic efficacy analyzes have been performed so far in 93 patients. The point is, however, to check the tendency and whether the thesis about the effectiveness of the drug has a chance to be confirmed before the end of the study – explained prof. Rejdak. «We see a trend in favor of amantadine. It was 62% effective, while placebo was 52% effective. when it comes to cure»- he pointed.

Prof. Szuster-Ciesielska: whether the drug is safe and effective, we will only find out after the end of the clinical trial

We asked prof. Agnieszka Szuster-Ciesielska from the Department of Virology and Immunology at the Maria Curie-Skłodowska University in Lublin. – Prof. Rejdak presented the results of a half-analysis involving 93 patients in two groups, one of whom received amantadine and the other – placebo. On the 15th day of the clinical trial, 62% of patients receiving amantadine were found to be asymptomatic, compared to 52% of those receiving placebo. On this basis, a conclusion was drawn that there is a trend towards the efficacy of amantadine. However, the difference in faster recovery between patients receiving amantadine or placebo is small, only 10%. – indicates the virologist.

– Therefore, instead of talking about the trend, which raises the legitimate hopes of the society, it would be more correct to say that at the moment there is no evidence supporting the effectiveness of amantadine in the treatment of early-stage COVID-19, the more so as only half-results have been presented – says Prof. Szuster-Ciesielska.

The professor also indicated that there were 41 reports of adverse effects in the safety analysis (17 in the amantadine group and 24 in the placebo group). – As the end of the study is scheduled for March 31, 2022, the Data Monitoring Committee (DMC), rather than the principal investigator, should decide on the safety of further study continuation. Likewise, no one (not just the principal investigator) is informed of “positive trends”.

Out of the planned 200 patients, 93 have been recruited so far, hence probably the decision of the Medical Research Agency to continue the research – says prof. Agnieszka Szuster-Ciesielska. – Whether the drug is safe and effective, we will only find out after the end of the clinical trial – underlines

Overall, there is currently no evidence that amantadine is effective in treating early-stage COVID-19. The press releases about preliminary results suggesting a positive effect of amantadine (even as a trend) are unfortunately harmful. They raise hopes and result in the fact that people heal themselves with an untested preparation – says prof. Szuster.

Head of ABM: At this stage, the claims about the effects of amantadine are inadmissible

To the words of prof. Rejdak also referred to the president of the Medical Research Agency, Dr. n. med. Radosław Sierpiński. «The partial results of the study (…) do not allow conclusions to be drawn about the alleged effectiveness of amantadine in the treatment of COVID-19. At this stage, making any claims as to the action of amantadine is completely unjustified »- emphasized the president of ABM.

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“We cannot in the least confirm that amantadine is effective in the early treatment of COVID-19, not least because of the small number of patients studied, let alone the lack of statistical significance. Currently, there is not even a trend towards its effectiveness observed, and the only observations concern the lack of significant side effects of its use »- added Radosław Sierpiński.

The President of ABM also noted that “while in the study with the use of amantadine in hospital treatment conducted by prof. Barczyk, the lack of effectiveness of amantadine with simultaneous side effects required the immediate suspension of the research, so in the case of research from Lublin, we want to complete the recruitment in order to dispel all doubts ». “At the moment, too small a group of patients and the short observation time do not allow any conclusions” – he emphasized.

«As of today, the state of knowledge has not changed – amantadine is not effective in the treatment of COVID and its use is contraindicated. I think that appropriate restraint resulting from scientific ethics should also apply to the researchers themselves. Research by prof. Barczyk showed that amantadine in COVID hospital treatment is ineffective, while the studies conducted in Lublin show that amantadine does not show improvement in treatment »- explained Dr. n. med. Radosław Sierpiński.

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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