KEY POINTS

  • The drugs ketamine and naltrexone have been reccuited in the fight against COVID-19
  • A clinical trial involving both drugs will be carried out by Beaumont Health of Michigan
  • Low doses of naltrexone, a drug approved for treating alcoholism and opiate addiction, and ketamine, a drug approved as an anesthetic, might be able to interrupt the inflammation that causes the worst COVID-19 symptoms

Ketamine and naltrexone, two widely-used drugs formulated in the 1960s, are finding their way to the front line of the global fight to develop a cure for COVID-19.

Beaumont Health has announced the launch of a new clinical study aimed at treating COVID-19 patients using naltrexone and ketamine. It also received approval from the U.S. Food and Drug Administration to launch the new clinical trial. This company is Michigan’s largest healthcare system based on revenue and inpatient admissions.

The study is called “SINK COVID-19” and will be conducted at the Beaumont Hospital in Royal Oak, Oakland County. SINK stands for the "Study of Immunomodulation using Naltrexone and Ketamine" for COVID-19. It has been designed as a randomized study for patients 18 years and older.

Beaumont researchers are hopeful both drugs can lessen the severity of COVID-19 symptoms by reducing the early and later side effects of the COVID-19 coronavirus. They intend to use the drugs as immunomodulators added to the treatment regimen of patients with COVID-19.  

They believe the drugs in tandem have the potential to decrease the severity of COVID-19 by reducing the autoimmune, hyperinflammatory stages of the virus, which is destructive to normal tissue and rapidly leads to death if left unchecked.

Low-dose naltrexone has been used to treat pain and inflammation in multiple sclerosis, Crohn’s disease, fibromyalgia and other pain conditions. Naltrexone is primarily used to manage alcohol or opioid dependence, and is sold under the brand names ReVia and Vivitrol, among others.

Ketamine is a drug mainly used for starting and maintaining anesthesia. It shows anti-inflammatory effects at multiple early steps in the inflammatory process. Other uses of ketamine include sedation in intensive care and treatment of pain and depression.

“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, 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.”

Map of Europe showing COVID-19 deaths per country. Map of Europe showing COVID-19 deaths per country. Photo: AFP / Sophie RAMIS

Dr. Annas Aljassem, study co-investigator, said what's needed is 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,” he said.

In its clinical trial application, Beaumont Health contends there is an urgent need to develop new treatments for COVID-19 infection using easily available and affordable medications. It said an ideal treatment for COVID-19 will have a two-pronged strategy.

The first is a treatment that will slow or interrupt the progression of the disease from mild/moderate (or stage 1-2A) to severe (stage 2B-3). The second will be a treatment to rescue patients who have become severe.

"We need to develop a treatment protocol which prevents progression of the disease and a treatment protocol to rescue those with advanced disease," argued Beaumont Health.