The single center, randomized study is only for patients, 18 years and older, hospitalized at Beaumont, Royal Oak for the treatment of COVID-19 meeting specific criteria.
Beaumont researchers are hopeful the two drugs can lessen the severity of COVID-19 symptoms by reducing the early and later side effects of the virus.
“There is an urgent need to develop new treatments for COVID-19 using easily available and affordable medications,” said Dr. Matthew Sims, director, Infectious Disease Research, Beaumont Health and study principal investigator. “Ideal new treatments for COVID-19 would help halt the progression of the disease in patients with mild cases prior to the need for ventilators, and provide a rescue treatment for patients with severe cases of the virus.”
The United States Food and Drug Administration’s Investigational New Drug program granted Beaumont researchers permission to start this clinical study.
Dr. Annas Aljassem, study co-investigator, said, “We need a two-pronged strategy to combat COVID-19. Low doses of naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms.”
Low-dose naltrexone has been used for the treatment of pain and inflammation in multiple sclerosis, Crohn’s disease, fibromyalgia and other pain conditions. Ketamine, an anesthetic drug, shows anti-inflammatory effects at multiple early steps in the inflammatory process.
“The addition of these two medications, as immunomodulators, to the treatment regimen of patients with COVID-19 has potential to decrease the severity of this disease by reducing the autoimmune, hyperinflammatory stages of the virus which is destructive to normal tissue and, when unchecked, rapidly leads to death,” Dr. Sims said.
The study was conceived and designed by Dr. Aljassem and Dr. Sims. Investigative team members also include Dr. Carl Lauter and Dr. Levi Hall.
The Applebaum Family Foundation, Beaumont Foundation, along with Suzanne and Deborah Tyner are supporting this study.
For more information on the study, go to clinicaltrials.gov, identifier: NCT04365985.
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