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Trial - NCT04365985


Column Value
Trial registration number NCT04365985
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04365985

First author
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Matthew Sims, MD PhD

Contact
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Maureen Cooney, Maureen.Cooney@beaumont.org (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-28

Recruitment status
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Factorial

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

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
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

William Beaumont Hospitals

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Sept. 14, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

70

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Progression of oxygenation needs

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Ketamine will be given as a rescue agent should a participant progress.", "treatment_id": 855, "treatment_name": "Naltrexone", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Ketamine will be given as a rescue agent should a participant progress.", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]