Trial Outcomes & Findings for Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19 (NCT NCT04365985)
NCT ID: NCT04365985
Last Updated: 2022-01-26
Results Overview
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)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
up to 1 month
Results posted on
2022-01-26
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
52
|
|
Overall Study
COMPLETED
|
9
|
9
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=52 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.45 years
STANDARD_DEVIATION 16.29 • n=39 Participants
|
68.52 years
STANDARD_DEVIATION 10.00 • n=41 Participants
|
68.11 years
STANDARD_DEVIATION 13.20 • n=35 Participants
|
67.82 years
STANDARD_DEVIATION 13.12 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
44 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
60 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
45 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=39 Participants
|
9 participants
n=41 Participants
|
52 participants
n=35 Participants
|
70 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to 1 monthCount 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)
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=52 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Progression of Oxygenation Needs
|
1 Participants
|
0 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: Missing data for 4 patients in Ketamine group
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.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=48 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Renal Failure
|
1 Participants
|
0 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: Missing data for 4 patients in Ketamine group
Count of participants who develop or experience worsened liver failure as defined by serum transaminases five times normal limits
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=48 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Liver Failure
|
0 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: Missing data for 4 patients in Ketamine group
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)
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=48 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Cytokine Storm
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 1 month post hospital dischargeCount of participants who die from COVID-19
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=52 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
COVID Mortality
|
0 Participants
|
0 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: Admission data not collected for Placebo and Naltrexone patients. Missing discharge data for 5 patients in ketamine group.
Length of hospital stay in days
Outcome measures
| Measure |
Placebo
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=47 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Length of Hospital Stay
|
—
|
—
|
21.37 days
Standard Deviation 15.89
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: Data not available for 1 patient in Naltrexone group and 5 patients in Ketamine group
Count of patients admitted to the ICU at any time during index hospitalization
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=8 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=47 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Intensive Care Unit (ICU) Admission
|
2 Participants
|
1 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: Patient in naltrexone group admitted to ICU had length of stay=0
Length of ICU stay in days
Outcome measures
| Measure |
Placebo
n=2 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=1 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=28 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Intensive Care Unit (ICU) Duration
|
2.56 days
Standard Deviation 0.71
|
0 days
Standard Deviation 0
|
16.68 days
Standard Deviation 11.25
|
SECONDARY outcome
Timeframe: up to 1 monthCount of participants requiring intubation
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=52 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Intubation
|
0 Participants
|
1 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: No patients in Placebo group were intubated. For those intubated, data not available for 4 patients of 29 intubated in the Ketamine group
Length of intubation, measured in days
Outcome measures
| Measure |
Placebo
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=1 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=25 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Intubation Duration
|
—
|
3.32 days
Standard Deviation 0
|
15.53 days
Standard Deviation 14.12
|
SECONDARY outcome
Timeframe: up to 1 monthPopulation: Patients not included who died during admission. Of 28 patients in ketamine group surviving to discharge, data missing for 5 patients. Of 8 patients in naltrexone group surviving to discharge, data missing for 1 patient.
Time measured in days from hospital admission to determination patient is stable for discharge
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=7 Participants
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=23 Participants
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Time Until Recovery
|
8.67 days
Standard Deviation 5.79
|
8.71 days
Standard Deviation 7.91
|
17.57 days
Standard Deviation 22.14
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Naltrexone
Serious events: 9 serious events
Other events: 7 other events
Deaths: 1 deaths
Ketamine
Serious events: 52 serious events
Other events: 52 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 participants at risk
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=52 participants at risk
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ACUTE ANEMIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
ACUTE CARDIAC ARREST DUE TO ARRYTHMIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
ACUTE CARDIOPULMONARY ARREST
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
ACUTE CEREBRAL EDEMA AND ACUTE ENCEPHALOPATHY RELATED TO SUBACUTE INFARCT
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Renal and urinary disorders
ACUTE RENAL FAILURE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
ANEMIA REQUIRING TRANSFUSION
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION PNEUMONITIS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
ASYSTOLE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
HEMORRHAGE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
CARDIOGENIC SHOCK SECONDARY TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
CARDIOPULMONARY ARREST
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Musculoskeletal and connective tissue disorders
CRITICAL ILLNESS MYOPATHY
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
33.3%
3/9 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.5%
6/52 • Number of events 6 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA, EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) E COLI
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Gastrointestinal disorders
GASTROINTESTINAL BLEED
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Vascular disorders
HEMATOMA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
HEMORRHAGIC SHOCK
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
HYPERKALEMIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
HYPOTENSION
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
9.6%
5/52 • Number of events 5 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
LABILE HYPOTENSION
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Infections and infestations
METHYCILLIN-RESISTANT STAPHLOCOCCUS AUREUS BACTEREMIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Renal and urinary disorders
OLIGOURIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Infections and infestations
PROGRESSION OF COVID-19
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
19.2%
10/52 • Number of events 10 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Infections and infestations
SEPSIS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Infections and infestations
SEPTIC SHOCK SECONDARY TO METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
SEVERE METABOLIC ENCEPHALOPATHY
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Infections and infestations
SEVERE SEPSIS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
SHOCK
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
9.6%
5/52 • Number of events 5 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
BACTEREMIA, STAPHLOCOCCUS EPIDERMIS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
TACHYCARDIS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
TOXIC METABOLIC ENCEPHALOPATHY
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEAL EDEMA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
TREMOR
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
UNSTABLE ARRYTHMIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo by mouth 1 time per day for patients with stage I or stage 2A COVID-19
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
Naltrexone
n=9 participants at risk
Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
|
Ketamine
n=52 participants at risk
Ketamine IV infusion (0.15 mg/kg maximum 20 mg every 6 hours) for patients with stage 2B or 3 COVID-19; may be increased to 0.3 mg/kg to a maximum of 30 mg every 6 hours if needed. Patients entering this arm from the placebo or naltrexone arms remain on those medications as well.
Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatients with mild/moderate COVID-19. Naltrexone will continue for 1 month post discharge. Patients progressing to requirement for advanced oxygenation will be reassessed and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation .
Placebo: Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
|
|---|---|---|---|
|
Psychiatric disorders
AGITATION
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Psychiatric disorders
ALTERED MENTAL STATUS
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
9.6%
5/52 • Number of events 5 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
BLEEDING
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
19.2%
10/52 • Number of events 10 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
CHEST PAIN
|
22.2%
2/9 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Musculoskeletal and connective tissue disorders
CRITICAL ILLNESS MYOPATHY
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
7.7%
4/52 • Number of events 4 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Skin and subcutaneous tissue disorders
CYST, LOWER EXTREMITY
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
ELEVATED HEART RATE/BLOOD PRESSURE
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Gastrointestinal disorders
EMESIS, ONE EPISODE
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Gastrointestinal disorders
EMESIS, FIVE EPISODES
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
EPITAXIS
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Injury, poisoning and procedural complications
FALL
|
22.2%
2/9 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
General disorders
FEVER
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
HEADACHE
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Renal and urinary disorders
HEMATURIA
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
3.8%
2/52 • Number of events 2 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
HYPOTENSION
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
General disorders
LETHARGY, INCREASED
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Gastrointestinal disorders
MELENA
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Injury, poisoning and procedural complications
PAIN, WRIST
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Skin and subcutaneous tissue disorders
RASH
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
9.6%
5/52 • Number of events 5 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
5.8%
3/52 • Number of events 3 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Nervous system disorders
TREMOR
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
1.9%
1/52 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Renal and urinary disorders
URINARY RETENTION
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
7.7%
4/52 • Number of events 4 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
General disorders
XEROSTOMIA
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/9 • 1 month
Systematic assessment of adverse events by review of medical records
|
11.1%
1/9 • Number of events 1 • 1 month
Systematic assessment of adverse events by review of medical records
|
0.00%
0/52 • 1 month
Systematic assessment of adverse events by review of medical records
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place