Status:

TERMINATED

Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

Lead Sponsor:

Corewell Health East

Conditions:

COVID-19

Acute Respiratory Distress Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 prov...

Detailed Description

There is an urgent need to develop new treatments for Novel Coronavirus-19 (COVID-19) infection using easily available and affordable medications. We need to develop a treatment protocol which prevent...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 29 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2021

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT04365985

Start Date

April 29 2020

End Date

April 1 2021

Last Update

January 26 2022

Active Locations (1)

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1

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073