Beaumont Hospital researchers are hoping that two common drugs can help treat COVID-19 patients.
The study is called SINK COVID-19, or the Study of Immunomodulation using Naltrexone and Ketamine for COVID-19.
Dr. Matthew Sims, Director of Infectious Disease Research for Beaumont, said that researchers hope the two drugs can interrupt the severe, damaging immune system response that can occur in COVID-19 patients.
“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 said.
“This study is twofold. It’s looking at whether naltrexone can prevent progression to the worst forms of COVID, and whether ketamine can rescue people who have gotten worse.”
Sims said researchers will administer naltrexone to patients in the earlier stages of COVID-19. If the disease worsens, they’ll then receive ketamine.
Some patients enrolled in the study will receive a placebo rather than naltrexone, Sims said.
“These kinds of studies really have to be done that way, because if you don’t use a placebo, you’ll never really know,” Sims said. “Did the people get better because of the drug, or was there something else going on? You have to be able to control it against nothing, basically.”
Sims said researchers hope to recruit 500 volunteers for the study from Beaumont-Royal Oak. He said it’s unclear when they’ll be able to get enough participants, especially since COVID-19 cases are declining in Metro Detroit. However, Sims said they’ll be able to do an interim analysis once they have results from 75 patients.
Sims said naltrexone and ketamine are generally considered to be very safe drugs, and will be administered in lower-than-normal doses to COVID patients. He said he’s not aware of any other U.S. researchers who have looked into this drug combination as a possible COVID treatment.
“We did a search, we couldn’t find anything,” Sims said. “Nobody else seems to have looked at this.”
The study has received U.S. Food and Drug Administration approval. Dr. Annas Aljassem is a study co-investigator along with Sims. Investigative team members also include Dr. Carl Lauter and Dr. Levi Hall. It will be funded through the Beaumont Foundation, and several health system donors.
Direct link and credit to https://www.michiganradio.org/ for the original story:https://www.michiganradio.org/post/beaumont-launches-study-whether-two-common-drugs-can-treat-covid-19
Direct link to clinical trials: https://clinicaltrials.gov/ct2/show/NCT04365985