Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

• Status: Terminated
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. 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 and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Beaumont Hospitals
• Treatments: Ketamine; Naltrexone

Criteria

Inclusion Criteria:

• Positive for COVID -19

• Admitted to Beaumont Hospital - Royal Oak, Michigan

• Age ≥18

• Receiving ≤ 6 liters/minute oxygen by nasal cannula for randomization to either placebo or naloxone arm OR receiving ≥ 6 liters/minute oxygen by nasal cannula or requiring advanced oxygenation for placement in ketamine arm

Exclusion Criteria:

• Known allergy to naltrexone

• Known allergy to ketamine

• Diagnosis of schizophrenia or psychosis

• Pregnancy based on available medical history, existing labs, or verbal report

• On chronic high dose opioids > 90mg morphine mg equivalence

• Use of naltrexone or Vivitrol within 90 days