drugset / Trial / NCT04365985

Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

NCT04365985

Phase 2 Terminated 70 enrolled Corewell Health East
RandomizedFactorialTriple-blindTreatment

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.

Timeline

Start
2020-04-29
Primary completion
2021-04-01
Completion
2021-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.15 mg/kg Intravenous
Subject Ketamine Small molecule 0.3 mg/kg Intravenous
Subject Naltrexone Small molecule 4.5 mg Oral