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Thursday, 06/25/2020 4:09:46 PM

Thursday, June 25, 2020 4:09:46 PM

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Vascepa /Argentina COVID19 Trial

COVID-19: looking to test whether an omega-3 fatty acid prevents contagion in health personnel
Matías A. Loewy
May 25, 2020
BUENOS AIRES, ARG. A clinical trial in Argentina will seek to verify whether prescription fish oil enriched with ethyl-eicosapentaenoic acid (ethyl icosapento), an omega-3 fatty acid, prevents the spread of COVID-19 or reduces the severity of symptoms among personnel of the health highly exposed to the virus, anticipated one of the main researchers.
The study is currently being evaluated by Argentine regulatory authorities for approval. And the protocol contemplates the participation of 1500 healthy or presumed healthy volunteers, who are going to take the medicine ( Vascepa, Amarin) or a placebo for two months.
"The expectation is that the risk of contagion will be reduced by at least 30%," Dr. Rafael Díaz, director of Clinical Trials in Latin America, who has participated in more than fifty published multicenter clinical trials , told Medscape in Spanish in magazines like The Lancet, The New England Journal of Medicine and Circulation.
"If the results were positive, it would be the most fascinating thing I have ever seen in my life," said Dr. Diaz. "If it costs little, has very few adverse effects, and is widely applicable, it would be a vaccine without being a vaccine."
The study's executive committee chair will be Dr. Deepak Bhatt, a professor of medicine at Harvard University and executive director of the cardiovascular interventions program at Brigham and Women's Hospital in Boston, United States, who led the REDUCE-IT study that found that high doses of ethyl-eicosapentaenoic acid reduce the risk of major cardiovascular events in patients with hypertriglyceridaemia plus cardiovascular disease or diabetes and an additional risk factor.
The new study will add to a list of fifty registered clinical studies in that seek to document the efficacy and safety of preventive interventions of COVID-19 with medications, nutrients or vaccines in health personnel.
Most of these studies focus on hydroxychloroquine (alone or in combination with azithromycin, bromhexine, zinc, or vitamins), but there are also others that try to evaluate chloroquine, Calmette-Guérin bacillus (BCG) vaccines, or against measles, nitric oxide, vitamin D3, intranasal iodopovidone, melatonin or even lactobacilli, among other interventions. A dozen of these studies are scheduled to take place in Spain, Brazil, Colombia and Mexico.
Biological foundations
As described by Dr. Díaz, there are three mechanisms of action that could support the usefulness of omega-3 fatty acids, and in particular eicosapentaenoic acid (EPA), in the prevention or treatment of COVID-19.
On the one hand, in vitro studies suggest that unsaturated fatty acids, especially eicosapentaenoic and docosahexanoic acids (DHA), can interfere with the lipid envelope of viruses, affect their functionality and prevent endocytosis, which is the previous step to their replication. intracellular. It is a "probably antiviral" effect, said Dr. Díaz.
By interfering with the viral membrane, omega-3 fatty acids could have a viricidal action, that is, act on the complete structure of the virus in the extracellular medium, virologist Laura Alché, Ph.D., director , told Medscape in Spanish of the Laboratory of Virology, Antiviral Agents and Cytoprotectors of the Faculty of Exact and Natural Sciences at the University of Buenos Aires, who will not participate in the study.
"However, we will have to test and see if these effects are also verified in vivo ," said Alché. "That doesn't always happen."
On the other hand, part of the cardiovascular benefits documented in the REDUCE-IT study could be attributed to the "proven" antithrombotic and anti-inflammatory effects of ethyl-eicosapentaenoic acid, said Dr. Díaz, which could act positively in the late stage of the disease if the study participants contract the infection.
In the literature supporting the study, the researchers cite, for example, a 2018 meta-analysis that showed that supplementation with omega-3 fatty acids can reduce the mortality rate from sepsis and sepsis-induced acute respiratory distress syndrome in adults. . [one]
In fact, less than a month ago, Italian researchers proposed that, because of their role in reducing reactive oxygen species and proinflammatory cytokines, omega-3 fatty acids "should be considered for potential interventions on COVID-19". [2]
Study design
According to the design of the study to be carried out in Argentina, the participating health personnel should undergo a swab for the polymerase chain reaction (PCR) test, as well as a serological test, on day zero and at two months .
In the active group, after a loading dose of 8 grams / day for three days, participants will take 4 grams of ethyl-eicosapentaenoic acid daily (two tablets in the morning, and two more in the evening). "It is the same dose from the REDUCE-IT study," said Dr. Díaz.
In the case of participants who contract COVID-19 during the study period, the researchers will examine if there are differences in the evolution in both groups according to a six-point ordinal scale that measures the severity of the infection.
Once approval of the study has been obtained by regulatory authorities and the ethics committee, the study medication, which is not marketed in the country, should be imported. Dr. Diaz is confident that participants could be recruited in the course of a month.
"If the results are positive, I imagine that the medication could be distributed worldwide and at a low price. On the other hand, since it does not have patent protection, it could be manufactured by any laboratory," emphasized Dr. Díaz, who added that he and the other participating researchers decided not to receive a fee for this trial.
For the virologist Alché, although an effective vaccine is the main bet to defeat the pandemic, it is also important to investigate antiviral drugs that can be both an "in the meantime" alternative and a long-term solution.
Health personnel in the front line of battle have been particularly affected by the pandemic, which, in addition to the work overload, adds fear of contagion. Spanish doctors surveyed reported the situation as of uncertainty, chaos, insecurity, improvisation, disaster, abandonment, disorganization, exhaustion, anxiety, impotence, indignation and confusion .
"Each professional handles the situation as best they can. My daughter, a pediatrician, who is on the front line, is afraid of getting sick, not so much for her, but for the fact that she could transmit the virus to others," she told Medscape. in Spanish, Dr. Carlota Russ, pediatric infectologist, member of the expert committee that advises Argentine President Alberto Fernández on the management of the pandemic.
Could preventive medication help? Maybe. But Dr. Russ said there is still no evidence that there is a working pharmacological intervention, beyond public health measures such as social distancing, hand washing, and the use of chinstrap.
Outside the context of clinical trials, "I would not recommend anyone to take any supposedly preventive medication, because there is no evidence and they can have adverse effects," he concluded.
The study will be financed by the Amarin company. Dr. Diaz, virologist Alché, Ph. D., and Dr. Russ have stated that they have no relevant financial conflicts of interest.
Follow Matías A. Loewy of Medscape in Spanish on Twitter @MLoewy .
For more content follow Medscape on Facebook , Twitter , Instagram and YouTube .
1. Chen H, Wang S, Zhao Y, Luo YT, et al. Correlation analysis of omega-3 fatty acids and mortality of sepsis and sepsis-induced ARDS in adults: data from previous randomized controlled trials. Nutr J. 31 May 2018; 17 (1): 57. doi: 10.1186 / s12937-018-0356-8. PMID: 29859104. Source
2. Messina G, Polito R, Monda V, Cipolloni L, et al. Functional Role of Dietary Intervention to Improve the Outcome of COVID-19: A Hypothesis of Work. Int J Mol Sci. 28 Apr 2020; 21 (9): E3104. doi: 10.3390 / ijms21093104. PMID: 32354030. Source
© 2020 WebMD, LLC
Cite this article: COVID-19: Seeking to Test Whether Omega-3 Fatty Acid Prevents Infections in Health Personnel - Medscape - May 25, 2020.
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