Trial · NCT04365985

Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19

NCT04365985, Phase 2, Terminated, Corewell Health East; results first posted 2022-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19. Trials, record NCT04365985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04365985

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19
NCT number: NCT04365985
Status: Terminated
Phases: Phase 2
Enrollment: 70 participants, actual
Lead sponsor: Corewell Health East
Conditions: COVID-19, Acute Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome (SARS), Coronavirus Infections
Interventions: Naltrexone, Ketamine, Placebo
First posted: 2020-04-28
Last updated: 2022-01-26
Results first posted: 2022-01-26

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression of Oxygenation Needs	up to 1 month	Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation)
Secondary	Renal Failure	up to 1 month	Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.
Secondary	Liver Failure	up to 1 month	Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits
Secondary	Cytokine Storm	up to 1 month	Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)
Secondary	COVID Mortality	up to 1 month post hospital discharge	Count of participants who die from COVID-19
Secondary	Length of Hospital Stay	up to 1 month	Length of hospital stay in days
Secondary	Intensive Care Unit (ICU) Admission	up to 1 month	Count of patients admitted to the ICU at any time during index hospitalization
Secondary	Intensive Care Unit (ICU) Duration	up to 1 month	Length of ICU stay in days
Secondary	Intubation	up to 1 month	Count of participants requiring intubation
Secondary	Intubation Duration	up to 1 month	Length of intubation, measured in days

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression of Oxygenation Needs	up to 1 month		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Renal Failure	up to 1 month	Missing data for 4 patients in Ketamine group	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Liver Failure	up to 1 month	Missing data for 4 patients in Ketamine group	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cytokine Storm	up to 1 month	Missing data for 4 patients in Ketamine group	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	COVID Mortality	up to 1 month post hospital discharge		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Length of Hospital Stay	up to 1 month	Admission data not collected for Placebo and Naltrexone patients. Missing discharge data for 5 patients in ketamine group.	days	MEAN
SECONDARY	Intensive Care Unit (ICU) Admission	up to 1 month	Data not available for 1 patient in Naltrexone group and 5 patients in Ketamine group	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Intensive Care Unit (ICU) Duration	up to 1 month	Patient in naltrexone group admitted to ICU had length of stay=0	days	MEAN
SECONDARY	Intubation	up to 1 month		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Intubation Duration	up to 1 month	No patients in Placebo group were intubated. For those intubated, data not available for 4 patients of 29 intubated in the Ketamine group	days	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Progression of Oxygenation Needs	Placebo	1	Participants
Progression of Oxygenation Needs	Naltrexone	0	Participants
Progression of Oxygenation Needs	Ketamine	21	Participants
Renal Failure	Placebo	1	Participants
Renal Failure	Naltrexone	0	Participants
Renal Failure	Ketamine	12	Participants
Liver Failure	Placebo	0	Participants
Liver Failure	Naltrexone	0	Participants
Liver Failure	Ketamine	4	Participants
Cytokine Storm	Placebo	0	Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	9
Overall Study	STARTED	Naltrexone	9
Overall Study	STARTED	Ketamine	52
Overall Study	COMPLETED	Placebo	9
Overall Study	COMPLETED	Naltrexone	9
Overall Study	COMPLETED	Ketamine	52
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Naltrexone	0
Overall Study	NOT COMPLETED	Ketamine	0

Source ClinicalTrials.gov

Adverse events237

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	AGITATION	Psychiatric disorders	Placebo	0	9	0
other	AGITATION	Psychiatric disorders	Naltrexone	0	9	0
other	AGITATION	Psychiatric disorders	Ketamine	3	52	3
other	ALTERED MENTAL STATUS	Psychiatric disorders	Placebo	1	9	1
other	ALTERED MENTAL STATUS	Psychiatric disorders	Naltrexone	0	9	0
other	ALTERED MENTAL STATUS	Psychiatric disorders	Ketamine	1	52	1
other	ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE	Cardiac disorders	Placebo	1	9	1
other	ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE	Cardiac disorders	Naltrexone	0	9	0
other	ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE	Cardiac disorders	Ketamine	5	52	5
other	BLEEDING	Blood and lymphatic system disorders	Placebo	0	9	0

1 to 10 of 237Source ClinicalTrials.gov

See all 237 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	9
Total, all-cause mortality	Naltrexone	1	9
Total, all-cause mortality	Ketamine	24	52
Total, other adverse events	Placebo	9	9
Total, other adverse events	Naltrexone	7	9
Total, other adverse events	Ketamine	52	52
Total, serious adverse events	Placebo	4	9
Total, serious adverse events	Naltrexone	9	9
Total, serious adverse events	Ketamine	52	52

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04365985

GET https://conductscience.org/api/trials/v1/NCT04365985/results?page=2

API reference For AI assistants