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There are preliminary results of further clinical trials on the efficacy of amantadine in the treatment of COVID-19 financed by the Medical Research Agency (ABM). - The conclusions are not tantamount to the results of the study of the drug carried out in Silesia so far - said the leader of the research project on amantadine prof. dr hab. Konrad Rejdak, MD, PhD.
Results of further studies on amantadine
- Preliminary results of studies on amantadine in the treatment of COVID-19 show a trend towards drug efficacy in patients included in the study within five days of confirmation of infection in the absence of significant side effects - said the leader of the research project, Prof. Konrad Rejdak, head of the SPSK Neurology Clinic No. 4 in Lublin.
Earlier results of analyzes on amantadine, which were reported by the head of another research group, Prof. Adam Barczyk from the Medical University of Silesia, showed that amantadine has no effect on the course of COVID-19 in moderately or severely ill patients. "In the COVID-19 patient population treated in hospital, there are no differences between those who used placebo or those who used amantadine," he said at a press conference. At that time, the Ombudsman for Patients' Rights, Bartłomiej Chmielowiec, emphasized that at the moment there was no scientific evidence that would confirm the effectiveness of amantadine treatment in patients suffering from COVID-19.
The study conducted by a clinical hospital in Lublin concerned people infected with SARS-CoV-2, burdened with severe COVID-19 factors such as age and comorbidities.
- Of approximately 500 SARS-CoV-2 infected patients who received early care in 7 clinical sites (active enrollment), 110 patients were enrolled and randomized in the study. Initial safety and efficacy analysis was performed on 93 clinical trial participants in both groups (placebo vs amantadine) who completed the 15-day follow-up period (double-blind phase). On the day of enrollment in the study (day 1), hospitalization was required by 19.6%. patients who were randomized to take amantadine and 14.6% patients who randomly received a placebo, while the remaining participants remained in outpatient follow-up -indicated.
A mild course of COVID-19 was observed in the majority of patients in both groups. - There was a trend towards the efficacy of amantadine, expressed on day 15 by a higher percentage of asymptomatic patients (62% amantadine vs. 52% placebo) and severe complications and death (amantadine 0% vs. placebo 4.6%). 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), the facility reported.
The hospital also reported that the results of early observation of the study participants showed, among others, positive benefit-risk (B / R) profile in the treatment of COVID-19 infection for patients treated with amantadine. In general, a mild course was observed in most of the participants of the analyzes, and 0.93% was also found. mortality in the entire population who participated in the study - 2.4% in the placebo group and 0% in the in the group receiving the preparation. - In connection with the implementation of this clinical trial, approximately 500 patients received qualified medical assistance in connection with the diagnosis of laboratory-confirmed SARS-COV-2 virus infection as part of pre-selection visits - we read in a statement from the Lublin hospital.
President of ABM: at the current stage of research, the claim about the effectiveness of amantadine in the treatment of COVID-19 not authorized
To the words of prof. Rejdak, the president of the Medical Research Agency, Dr. n. med. Radosław Sierpiński. - 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, it is completely illegal to make any claims about the effects of amantadine, he said.
In the opinion of Dr. Sierpiński, it cannot be “confirmed to the slightest extent that amantadine works in the early treatment of COVID-19, not only because of the small group of patients studied, not to mention the lack of statistical significance”. - Currently, there is not even a trend towards its effectiveness, and the only observations concern the lack of significant side effects of its use - he emphasized.
Dr. Sierpiński points out that the group of patients is too small and the observation time is short, which do not allow for any conclusions. - First of all, I warn politicians and self-proclaimed pseudoscientists against misleading patients and claiming that amantadine works - it should be clearly emphasized that this is not true -appealed.
- As of today, the state of the art 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 inpatient treatment is ineffective, while studies conducted in Lublin show that amantadine does not show improvement in treatment - explained the president of ABM.
Research on amantadine will continue
Research under the supervision of prof. Konrad Rejdak will be continued to assess the impact of amantadine on the occurrence of delayed complications of COVID-19. ABM will "continue clinical trials based on preliminary results, with enrollment planned until April 15, 2022 in the double-blind section and extension of the open-label follow-up for another 6 months."
The President of the Medical Research Agency 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, in the case of studies from Lublin, we want to complete the recruitment to dispel any doubts ".