Researchers at Beaumont Hospital, Royal Oak have begun enrolling patients in a new clinical study aimed at treating COVID-19 with two common drugs – naltrexone and ketamine. The study is called the Study of Immunomodulation using Naltrexone and Ketamine for COVID-19 (SINK COVID-19).
The U.S. Food and Drug Administration’s Investigational New Drug program granted Beaumont researchers permission to start the clinical study.
“There is an urgent need to develop new treatments for COVID-19 using easily available and affordable medications,” says Dr. Matthew Sims, director of infectious disease research at 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 single center, randomized study is only for patients who are 18 years and older hospitalized at the location for the treatment of COVID-19. 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.
“We need a two-pronged strategy to combat COVID-19,” says Dr. Annas Aljassem, study co-investigator. “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 painful 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,” Sims says.
The study was created and designed by Aljassem and Sims. The Applebaum Family Foundation, Beaumont Foundation, and Suzanne and Deborah Tyner are supporting the study.
Beaumont Health is based in Southfield and is Michigan’s largest health care system.