Trial Outcomes & Findings for Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis (NCT NCT04331795)
NCT ID: NCT04331795
Last Updated: 2022-06-09
Results Overview
Number of Participants with Clinical Response in Maximum Temperature (Tmax)
COMPLETED
PHASE2
32 participants
Assessed for the 24 hour period after tocilizumab administration
2022-06-09
Participant Flow
Participant milestones
| Measure |
Group A
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
20
|
|
Overall Study
COMPLETED
|
12
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis
Baseline characteristics by cohort
| Measure |
Group A
n=12 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=93 Participants
|
66 years
n=4 Participants
|
69 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
20 participants
n=4 Participants
|
32 participants
n=27 Participants
|
|
C-Reactive protein
|
175 mg/L
STANDARD_DEVIATION 83.1 • n=93 Participants
|
138 mg/L
STANDARD_DEVIATION 76.0 • n=4 Participants
|
152 mg/L
STANDARD_DEVIATION 79.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: Assessed for the 24 hour period after tocilizumab administrationNumber of Participants with Clinical Response in Maximum Temperature (Tmax)
Outcome measures
| Measure |
Group A
n=12 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Number of Participants With Clinical Response in Maximum Temperature (Tmax)
|
8 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administrationPopulation: One patient in Group A and 2 patients in Group B were deceased before measure of CRP.
Number of Participants with Biochemical Response as determined by CRP Response. Defined as at least 25% decrease in CRP from baseline at least 16 hours after administration of drug.
Outcome measures
| Measure |
Group A
n=11 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=18 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Number of Participants With Biochemical Response as Determined by CRP Response
|
10 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 28 days28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of the first dose of tocilizumab.
Outcome measures
| Measure |
Group A
n=12 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Overall Survival
|
10 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Hospitalization, up to 4 weeks after tocilizumab administrationThis will be defined as the percentage of patients who are discharged in stable condition compared to the percentage of patients who die in the hospital. Patients who are discharged to hospice will be excluded from this calculation.
Outcome measures
| Measure |
Group A
n=12 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Survival to Hospital Discharge
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Hospitalization, up to 4 weeks after tocilizumab administrationPopulation: No data were collected on this outcome. Given the volumes of patients being cared for and demand for radiology services, it proved impractical during the conduct of the trial to re-examine radiographs of every enrolled patient in the absence of a clinical reason.
This will be a binary outcome defined by worsening COVID-19 pneumonitis resulting in transition from clinical Group A or Group B COVID-19 pneumonitis to critical COVID-19 pneumonitis during the course of the patient's COVID-19 infection. This diagnosis will be determined by treating physicians on the basis of worsening pulmonary infiltrates on chest imaging as well as clinical deterioration marked by persistent fever, rising supplemental oxygen requirement, declining PaO2/FiO2 ratio, and the need for intensive care such as mechanical ventilation or vasopressor/inotrope medication(s).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hospitalization, up to 4 weeks after tocilizumab administrationThis will be a binary outcome defined as worsening COVID-19 disease resulting in the use of non-invasive (BiPap, heated high-flow nasal cannula) or invasive positive pressure ventilation during the course of the patient's COVID-19 infection. For patients admitted to the hospital using non-invasive mechanical ventilation, the utilization of mechanical ventilation will count toward this metric, as well. Calculated as the ratio of the number of patients who require non-invasive or invasive positive pressure ventilation during hospitalization and total number of patients who receive tocilizumab.
Outcome measures
| Measure |
Group A
n=12 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Rate of Non-elective Mechanical Ventilation
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Hospitalization, up to 4 weeks after tocilizumab administrationThis will be a continuous outcome defined by the amount of time between initiation and cessation of mechanical ventilation (invasive and non-invasive).
Outcome measures
| Measure |
Group A
n=12 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
2.5 days
Interval 0.0 to 8.0
|
3.5 days
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: Assessed over hospitalization, up to 4 weeks after tocilizumab administrationThis will be a continuous outcome defined by the amount of time between tocilizumab dose administration and the initiation of mechanical ventilation. This will be treated as a time-to-event with possible censoring.
Outcome measures
| Measure |
Group A
n=12 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 Participants
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Time to Mechanical Ventilation
|
2 days
Interval 0.0 to 12.0
|
3.5 days
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: Hospitalization, up to 4 weeks after tocilizumab administrationPopulation: In reviewing inotropic medication utilization, there was a disconnect between orders being placed and medication administration, precluding high-throughput data extraction from electronic health record.
This will be a binary outcome defined as utilization of any vasopressor or inotropic medication during the course of the patient's COVID-19 infection. Calculated as the ratio of the number of patients who require vasopressor or inotrope medication during hospitalization and total number of patients who receive tocilizumab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hospitalization, up to 4 weeks after tocilizumab administrationPopulation: In reviewing inotropic medication utilization, there was a disconnect between orders being placed and medication administration, precluding high-throughput data extraction from electronic health record.
This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor or inotrope medication(s).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed over hospitalization, up to 4 weeks after tocilizumab administrationPopulation: In reviewing inotropic medication utilization, there was a disconnect between orders being placed and medication administration, precluding high-throughput data extraction from electronic health record.
This will be a continuous outcome defined by the amount of time between first tocilizumab dose administration and the initiation of vasopressor or inotropic medication(s). This will be treated as a time-to-event with possible censoring.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hospitalization, up to 4 weeks after tocilizumab administrationPopulation: Median number of ICU days could not be calculated from our records due to lag in timing of ICU admission order placement, ICU arrival, ICU transfer order, and general ward admission order placement. Therefore, no data was collected for this outcome.
Number of ICU days is defined as the time period when a patient is admitted to the ICU (defined as the timestamp on the first vital signs collected in an ICU) until they are transferred from the ICU to a non-ICU setting such as a general acute care bed (defined as the timestamp on the first vital signs collected outside an ICU, excepting any "off the floor" vital signs charted from operating rooms or procedure or imaging suites). Death in the ICU will be a competing risk.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed over hospitalization, up to 4 weeks after tocilizumab administrationPopulation: 0 patients analyzed due to heterogeneity in the recording of supplemental oxygen requirement in the electronic health record, complicating data extraction and analysis. There were no patient data collected for this outcome.
Duration of increased supplemental oxygen requirement from baseline is defined as the time period (number of days) during which the participant requires supplemental oxygen in excess of his/her baseline supplemental oxygen requirement. The supplemental oxygen requirement is defined as the highest liters-per-minute flow of supplemental oxygen required by the patient each day over the course of the hospitalization.
Outcome measures
Outcome data not reported
Adverse Events
Group A
Group B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=12 participants at risk
Hospitalized, non-critically ill patients with COVID-19 pneumonitis with risk factors for decompensation
Tocilizumab: Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
Group B
n=20 participants at risk
Hospitalized, non-critically ill patients with COVID-19 pneumonitis without risk factors for decompensation
Tocilizumab: Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if:
1. Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
2. CRP decrease is \< 25% at 24 hours following tocilizumab administration and CRP \> 40mg/L
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Cardiac disorders
QTC prolangulation
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Cardiac disorders
Type II NSTEMO
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Cardiac disorders
Chest pain
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Ear and labyrinth disorders
Blurred vision
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • 28 days
|
0.00%
0/20 • 28 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/12 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Gastrointestinal disorders
Emisis
|
8.3%
1/12 • Number of events 1 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Gastrointestinal disorders
Hematoschezia
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Gastrointestinal disorders
Thick secretions
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
General disorders
Poor appetite
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Infections and infestations
H. Pylori infection
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Infections and infestations
Acinetobacter PNA
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • Number of events 1 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Investigations
ALT elevation
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Investigations
AST elevation
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Investigations
Creatinine elevation
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Infections and infestations
BUN elevation
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Infections and infestations
Bilirubin elevation
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Endocrine disorders
Hypokalemia
|
0.00%
0/12 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Endocrine disorders
Starvation ketosis
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/12 • 28 days
|
15.0%
3/20 • Number of events 3 • 28 days
|
|
Endocrine disorders
Hyperkalemia
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Endocrine disorders
Hypernatremia
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Endocrine disorders
Hypocalcemia
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/12 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Endocrine disorders
Hypophosphatemia
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Endocrine disorders
Transaminitis
|
8.3%
1/12 • Number of events 1 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Right arm contracture
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Bone mineral disease
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Nervous system disorders
Multifocal subacute stroke
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Delirium
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Worsening altered mental status
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • 28 days
|
15.0%
3/20 • Number of events 3 • 28 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12 • 28 days
|
10.0%
2/20 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
healthcare-associated pneumonia
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration event pneumonitis
|
8.3%
1/12 • Number of events 1 • 28 days
|
0.00%
0/20 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
|
Vascular disorders
Right soleal deep vein thrombosis
|
0.00%
0/12 • 28 days
|
5.0%
1/20 • Number of events 1 • 28 days
|
Additional Information
Dr. Pankti Reid
University of Chicago, Department of Medicine Section of Rheumatology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place