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

Outcome

Outcome not reported

Stopped (Enrollment): “Because of the decrease in COVID cases, enrollment is extremely low. Given the current study design, it is not possible to gather data necessary to answer the question about whether study treatment reduces mortality”

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