May 26, 2020 – KGK Science is developing a protocol with Hofseth Biocare for an accelerated phase 2 clinical trial assessing Hofseth’s CARDIO soft gels, a natural salmon oil-based reducer of eosinophil effector function, as a treatment for patients with Acute Respiratory Distress Syndrome (ARDS) caused by the SARS-CoV-2 virus. The clinical trial will examine the progression from mild to severe COVID-19 in SARS-CoV-2 infected patients who identify as former smokers and/or steroid-resistant asthma patients currently hospitalized due to the severity of their infection.
The single-center, randomized, comparator-controlled, open-label, parallel study will assess 100 hospitalized patients over a period of 28 days. The patients will receive the best current antiviral standard of care (BSC) in the placebo arm and BSC+CARDIO soft gels in the treatment arm with the primary endpoint being the number of days on assisted ventilation.
Publications from the U.S. Centers for Disease Control and Prevention (CDC) show former smokers to be at particularly high risk for COVID-19-based ARDS progression into ICU care. As such, this population has been chosen to examine the efficacy of CARDIO in reducing the need for mechanical respiratory support. The study will also examine the alleviation of respiratory symptoms and the reduction of mortality in this high-risk population.
“KGK Science is proud to be working alongside our colleagues in the clinical research community during this unprecedented global health crisis,” says Najla Guthrie, President and CEO at KGK. “The potential for natural therapeutic treatments for alleviating symptoms and possibly reducing the spread of COVID-19 are far-reaching and we are pleased to be able to offer our expertise and services to facilitate this much-needed research.”
KGK’s regulatory team, led by former U.S. FDA Regulator Dr. Corey Hilmas, will be submitting the Clinical Trial Application to the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada for an expedited review under a new measure put in place by the government agency to fight the outbreak of COVID-19. Following regulatory approvals, the trial will begin patient recruitment in partnership with select hospitals in Ontario.
More About This Trial:
Global News Wire: Hofseth Biocare ASA: HBC has begun protocol development for its accelerated Phase 2 clinical trial with OmeGo® to decrease Acute Respiratory Distress Syndrome and the need for assisted respiration in COVID-19 patients
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