Treatments containing fish oil, omega-3 fatty acids being trialed on COVID-19 patients
In an effort to suppress and ultimately stifle the spread of the global COVID-19 pandemic, the world’s scientific and medical communities are turning to treatments containing omega-3 fatty acids and fish oil for help.
Clinical trials will soon be run by KD Pharma Group and its partner, SLA Pharma, to test the effectiveness of its new drug, EPAspire, on patients symptomatic with inflammatory cytokines, which is believed to play a part in COVID-19’s progression. The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has moved to expedite trials of the drug, while discussions with authorities in other European countries are underway, KD Pharma announced on 14 April.
“We hope EPAspire will be able to reduce the risk of coronavirus complications progressing to serious outcomes like ARDS, the need for artificial ventilation and intensive care,” KD Pharma CEO Oscar Groet said in a press release. “This unique preparation has potential, to not only modify the COVID-19 disease process, reducing harmful, excess inflammatory responses, but to do so without suppressing the immune response to the virus which are vital to seroconversion giving the patient ongoing protection against continued viral challenge."
Consisting of a novel formulation of highly-purified eicosapentaenoic acid free fatty acid (EPA-FFA), EPAspire comes in gastro-resistant capsules. The drug was already being trialed in Europe in multiple countries for the possible treatment of familial adenomatous polyposis (FAP), contributing to KD Pharma – one of the world’s largest omega-3 fatty acid producers – and SLA being able to initiate the COVID-19 trials “very rapidly,” the companies said.
Participating in the trials will be eligible patients with positive COVID-19 test results, KD Pharma said. Following enrollment, trial patients will be given EPAspire within a day of hospitalization and continue their treatment for one month, with a two-week follow-up.
“They will be monitored for progression to more serious outcomes and markers of inflammation, with the aim that EPAspireTM could help reduce the risk of mortality in severely ill patients,” KD Pharma and SLA noted.
SLA CEO Justin Slagel said he and his team are spearheading an effort to “expedite the trials in the various countries working closely with the respective regulatory authorities.”
Primary investigators in Italy who designed the protocol believe EPA-FFA could potentially alter the course of coronavirus infections by “modulating immune response and protecting patients from its most severe complications.”
“EPA as a free fatty acid is very promptly absorbed and incorporated into the body’s phospholipid membranes, and then starts to act very quickly. Once incorporated into cell membranes, EPA-FFA significantly affects the production of pro-inflammatory mediators such as IL-6 and leukotriene B4 that play a crucial role in starting and maintaining the inflammatory process in the lungs. Moreover, EPA-FFA metabolism generates pro-resolving mediators and bioactive metabolites, that enhance innate microbial killing and organ protection,” the investigators said.
In Iceland, coronavirus treatments featuring omega-3 components are also being explored. Kerecis and the National Hospital of Iceland are in the process of conducting a randomized, controlled, double-blind clinical study investigating the effectiveness of the Kerecis’ Omega3 Viruxide system on COVID-19 patients.
Omega3 Viruxide, which is a virucidal and bactericidal system used in the Kerecis Primary Wound Spray, helps to control infections and has been on the market in several countries for years, Kerecis said.
“Recognizing this benefit, Italian doctors are using the product off-label to spray into the oral and nasal cavities of patients believed to have early onset of COVID-19, for the purpose of preventing the progression of the disease,” the company noted.
Professor Giuseppe Noschese, who serves as the acting resident of the International Disaster Medicine Association, the coordinator of the Trauma Center Unit at Ospedale Del Mare in Naples, Italy, and a COVID-19 task force leader, said the initial off-label trials of the treatment in Italy have been positive.
“I have been using the spray to treat wounds for years here in Italy and have been impressed with its ability to protect wounds from infections," he said. "We were confronted by the lack of therapeutic solutions to treat COVID-19 and were inspired to use the spray. Our observations after treating more than 70 patients are very promising."
Ragnar Freyr Ingvarsson, medical director of the National Hospital of Iceland COVID-19 task force, said he has also seen previous outcomes in clinical trials with the Kerecis spray.
“Like Italy, Iceland lacks therapeutic solutions to treat COVID-19 patients,” Ingvarsson said. “Since 2014, we have run multiple clinical trials in partnership with Kerecis. The news about the innovative use of the Kerecis spray in Italy triggered immediate preparation for a clinical trial here with the patients in our COVID-19 outpatient department. Given the current pandemic, we are committed to executing this trial as quickly and efficaciously as possible, while assuring the highest quality.”
Used in many Kerecis products, the Omega3 Viruxide system contains patented fatty acids that decrease viral load and curb the symptoms of an infection, which “increases the chances the body’s immune system can combat the virus,” Kerecis Vice President of Clinical Development Hilmar Kjartansson said.
Kerecis Primary Wound Spray is available in the entire European Union, Switzerland, the U.K., Canada, South Korea, South Africa, and Australia. The company is working with medical institutions in the United States and Italy to do additional clinical trials, it said, and is also coordinating with the FDA and BARDA to get regulatory approval in the U.S.
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