TerminatedPhase 2ketamine

Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

Sponsored by Corewell Health East

NCT ID
NCT04365985
Target Enrollment
70 participants
Start Date
2020-04-29
Est. Completion
2021-04-01

About This Study

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.

Conditions Studied

COVID-19Acute Respiratory Distress SyndromeSevere Acute Respiratory Syndrome (SARS)Coronavirus Infections

Interventions

  • Naltrexone
  • Ketamine
  • Placebo

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility 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

Study Locations (1)

William Beaumont Hospital
Royal Oak, Michigan, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source