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Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis (COVIDOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331795
Recruitment Status : Completed
First Posted : April 2, 2020
Results First Posted : June 9, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COVID-19
Intervention Drug: Tocilizumab
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B
Hide Arm/Group Description

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

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
Period Title: Overall Study
Started 12 20
Completed 12 20
Not Completed 0 0
Arm/Group Title Group A Group B Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 12 20 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 12 participants 20 participants 32 participants
70
(51 to 73)
66
(41 to 73)
69
(41 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 20 participants 32 participants
Female
5
  41.7%
11
  55.0%
16
  50.0%
Male
7
  58.3%
9
  45.0%
16
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 20 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  75.0%
16
  80.0%
25
  78.1%
White
1
   8.3%
0
   0.0%
1
   3.1%
More than one race
0
   0.0%
3
  15.0%
3
   9.4%
Unknown or Not Reported
2
  16.7%
1
   5.0%
3
   9.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 20 participants 32 participants
12 20 32
C-Reactive protein  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 12 participants 20 participants 32 participants
175  (83.1) 138  (76.0) 152  (79.2)
1.Primary Outcome
Title Number of Participants With Clinical Response in Maximum Temperature (Tmax)
Hide Description Number of Participants with Clinical Response in Maximum Temperature (Tmax)
Time Frame Assessed for the 24 hour period after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 12 20
Measure Type: Count of Participants
Unit of Measure: Participants
8
  66.7%
16
  80.0%
2.Primary Outcome
Title Number of Participants With Biochemical Response as Determined by CRP Response
Hide Description 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.
Time Frame Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
One patient in Group A and 2 patients in Group B were deceased before measure of CRP.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 18
Measure Type: Count of Participants
Unit of Measure: Participants
10
  90.9%
15
  83.3%
3.Secondary Outcome
Title Overall Survival
Hide Description 28-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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 12 20
Measure Type: Count of Participants
Unit of Measure: Participants
10
  83.3%
17
  85.0%
4.Secondary Outcome
Title Survival to Hospital Discharge
Hide Description This 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.
Time Frame Hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 12 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
2
  10.0%
5.Secondary Outcome
Title Progression of COVID-19 Pneumonitis
Hide Description 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).
Time Frame Hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Rate of Non-elective Mechanical Ventilation
Hide Description This 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.
Time Frame Hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 12 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
4
  20.0%
7.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description This will be a continuous outcome defined by the amount of time between initiation and cessation of mechanical ventilation (invasive and non-invasive).
Time Frame Hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 12 20
Median (Full Range)
Unit of Measure: days
2.5
(0 to 8)
3.5
(1 to 9)
8.Secondary Outcome
Title Time to Mechanical Ventilation
Hide Description This 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.
Time Frame Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 12 20
Median (Full Range)
Unit of Measure: days
2
(0 to 12)
3.5
(2 to 8)
9.Secondary Outcome
Title Rate of Vasopressor/Inotrope Utilization
Hide Description 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.
Time Frame Hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Duration of Vasopressor/Inotrope Utilization
Hide Description 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).
Time Frame Hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Time to Vasopressor or Inotropic Utilization
Hide Description 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.
Time Frame Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of ICU Days
Hide Description 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.
Time Frame Hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Duration of Increased Supplemental Oxygen Requirement From Baseline
Hide Description 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.
Time Frame Assessed over hospitalization, up to 4 weeks after tocilizumab administration
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B
Hide Arm/Group Description

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

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
All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   2/12 (16.67%)      3/20 (15.00%)    
Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/12 (75.00%)      17/20 (85.00%)    
Blood and lymphatic system disorders     
Anemia   1/12 (8.33%)  1 1/20 (5.00%)  1
Cardiac disorders     
QTC prolangulation   0/12 (0.00%)  0 1/20 (5.00%)  1
Type II NSTEMO   1/12 (8.33%)  1 0/20 (0.00%)  0
Atrial Flutter   0/12 (0.00%)  0 1/20 (5.00%)  1
Chest pain   1/12 (8.33%)  1 1/20 (5.00%)  1
Tachycardia   1/12 (8.33%)  1 2/20 (10.00%)  2
Ear and labyrinth disorders     
Blurred vision   1/12 (8.33%)  1 0/20 (0.00%)  0
Endocrine disorders     
Hypokalemia   0/12 (0.00%)  0 2/20 (10.00%)  2
Starvation ketosis   1/12 (8.33%)  1 0/20 (0.00%)  0
Hyperglycemia   0/12 (0.00%)  0 3/20 (15.00%)  3
Hyperkalemia   1/12 (8.33%)  1 1/20 (5.00%)  1
Hypernatremia   0/12 (0.00%)  0 1/20 (5.00%)  1
Hypocalcemia   0/12 (0.00%)  0 1/20 (5.00%)  1
Hypoglycemia   0/12 (0.00%)  0 2/20 (10.00%)  2
Hypophosphatemia   1/12 (8.33%)  1 1/20 (5.00%)  1
Transaminitis   1/12 (8.33%)  1 1/20 (5.00%)  1
Gastrointestinal disorders     
Nausea   1/12 (8.33%)  1 1/20 (5.00%)  1
Constipation   2/12 (16.67%)  2 0/20 (0.00%)  0
Diarrhea   0/12 (0.00%)  0 1/20 (5.00%)  1
Dysphagia   0/12 (0.00%)  0 2/20 (10.00%)  2
Emisis   1/12 (8.33%)  1 2/20 (10.00%)  2
Hematoschezia   1/12 (8.33%)  1 0/20 (0.00%)  0
Thick secretions   1/12 (8.33%)  1 0/20 (0.00%)  0
General disorders     
Fatigue   1/12 (8.33%)  1 1/20 (5.00%)  1
Fever   1/12 (8.33%)  1 1/20 (5.00%)  1
Poor appetite   1/12 (8.33%)  1 1/20 (5.00%)  1
Infections and infestations     
H. Pylori infection   0/12 (0.00%)  0 1/20 (5.00%)  1
Acinetobacter PNA   1/12 (8.33%)  1 0/20 (0.00%)  0
Urinary tract infection   1/12 (8.33%)  1 2/20 (10.00%)  2
BUN elevation   1/12 (8.33%)  1 0/20 (0.00%)  0
Bilirubin elevation   0/12 (0.00%)  0 1/20 (5.00%)  1
Investigations     
ALT elevation   0/12 (0.00%)  0 1/20 (5.00%)  1
AST elevation   0/12 (0.00%)  0 1/20 (5.00%)  1
Creatinine elevation   0/12 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Back pain   0/12 (0.00%)  0 1/20 (5.00%)  1
Right arm contracture   1/12 (8.33%)  1 0/20 (0.00%)  0
Bone mineral disease   1/12 (8.33%)  1 0/20 (0.00%)  0
Nervous system disorders     
Multifocal subacute stroke   1/12 (8.33%)  1 0/20 (0.00%)  0
Headache   0/12 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders     
Delirium   0/12 (0.00%)  0 1/20 (5.00%)  1
Worsening altered mental status   0/12 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders     
Acute kidney injury   0/12 (0.00%)  0 3/20 (15.00%)  3
Chronic kidney disease   0/12 (0.00%)  0 1/20 (5.00%)  1
Hematuria   0/12 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   0/12 (0.00%)  0 2/20 (10.00%)  2
Dyspnea   0/12 (0.00%)  0 2/20 (10.00%)  2
healthcare-associated pneumonia   0/12 (0.00%)  0 1/20 (5.00%)  1
Aspiration event pneumonitis   1/12 (8.33%)  1 0/20 (0.00%)  0
Pneumothorax   0/12 (0.00%)  0 1/20 (5.00%)  1
Pulmonary embolism   0/12 (0.00%)  0 1/20 (5.00%)  1
Vascular disorders     
Right soleal deep vein thrombosis   0/12 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Pankti Reid
Organization: University of Chicago, Department of Medicine Section of Rheumatology
Phone: 773-702-6119
EMail: pankti.reid@uchospitals.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04331795    
Other Study ID Numbers: IRB20-0515
First Submitted: April 1, 2020
First Posted: April 2, 2020
Results First Submitted: April 19, 2021
Results First Posted: June 9, 2022
Last Update Posted: June 9, 2022