Trial Outcomes & Findings for Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19 (NCT NCT04479358)

Last Updated: 2026-06-08

Results Overview

Day of recovery is defined as the first day on which the patient achieves one of the following two categories from a seven-point ordinal scale: 6) Hospitalized, not requiring supplemental oxygen or ongoing medical care or 7) Not hospitalized. Time to recovery is the number of days from randomization to achievement of this status. Note that the ordinal scale is measured once daily, with the patient's worst clinical status during the 24-hour time period (0:00-23:59) being documented.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

85 participants

Primary outcome timeframe

28 days

Results posted on

2026-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Sub-study A, Tocilizumab-Free Standard of Care Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study A, Tocilizumab 120mg Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Overall Study STARTED	26	25	26	3	3	2
Overall Study COMPLETED	26	25	25	3	3	1
Overall Study NOT COMPLETED	0	0	1	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sub-study A, Tocilizumab-Free Standard of Care Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study A, Tocilizumab 120mg Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Overall Study Withdrawal by Subject	0	0	1	0	0	1

Baseline Characteristics

Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Total n=83 Participants Total of all reporting groups
Age, Continuous	57.5 years n=9 Participants	56.5 years n=27 Participants	59.2 years n=267 Participants	49.7 years n=265 Participants	53.3 years n=568 Participants	72 years n=22 Participants	57.5 years n=23 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	15 Participants n=27 Participants	15 Participants n=267 Participants	3 Participants n=265 Participants	2 Participants n=568 Participants	1 Participants n=22 Participants	45 Participants n=23 Participants
Sex: Female, Male Male	17 Participants n=9 Participants	10 Participants n=27 Participants	10 Participants n=267 Participants	0 Participants n=265 Participants	1 Participants n=568 Participants	0 Participants n=22 Participants	38 Participants n=23 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Black or African American	23 Participants n=9 Participants	21 Participants n=27 Participants	23 Participants n=267 Participants	3 Participants n=265 Participants	2 Participants n=568 Participants	1 Participants n=22 Participants	73 Participants n=23 Participants
Race (NIH/OMB) White	1 Participants n=9 Participants	3 Participants n=27 Participants	2 Participants n=267 Participants	0 Participants n=265 Participants	1 Participants n=568 Participants	0 Participants n=22 Participants	7 Participants n=23 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	3 Participants n=23 Participants
Region of Enrollment United States	26 participants n=9 Participants	25 participants n=27 Participants	25 participants n=267 Participants	3 participants n=265 Participants	3 participants n=568 Participants	1 participants n=22 Participants	83 participants n=23 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Note: for confidence intervals below, -9999 and 9999 = Upper or lower limit cannot be estimated due to insufficient number of participants with events.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Time to Recovery	4 days Interval 4.0 to 5.0	5 days Interval 4.0 to 6.0	7 days Interval 4.0 to 9.0	7 days Interval 2.4 to Insufficient number of patients to compute upper confidence limit	6 days Interval 4.0 to Insufficient number of patients to compute upper confidence limit	8 days Insufficient number of patients to compute confidence limits

SECONDARY outcome

Timeframe: 7 days

This will be defined as the percentage of patients achieving one of the following two categories by day 7: hospitalized but not requiring supplemental oxygen or ongoing medical care or not hospitalized.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Achievement of Recovery	20 Participants	19 Participants	14 Participants	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

This will be defined as the percentage of patients in a given arm of the study who are alive thirty days following randomization. Patients who are discharged to hospice will be counted as deceased on the day of discharge. Patients who are transitioned to inpatient hospice or inpatient comfort measures only will be counted as deceased on the day of transition.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Overall Survival	25 Participants	24 Participants	22 Participants	3 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 1 year

This will be defined as the number of days that pass between the day of a patient's randomization and his or her discharge from the hospital.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Hospital Length of Stay	5 days Interval 1.0 to 23.0	5 days Interval 1.0 to 18.0	6 days Interval 3.0 to 21.0	7 days Interval 4.0 to 23.0	6 days Interval 4.0 to 15.0	8 days Interval 8.0 to 8.0

SECONDARY outcome

Timeframe: 24-hour period immediately preceding randomization and 24-hour period immediately following randomization

Population: Sub-study A, SOC: 16 patients had missing data; Sub-study A, 40 mg: 11 patients had missing data; Sub-study A, 120 mg: 15 patients had missing data; Sub-study B, 400 mg: 3 patients had missing data; Sub-study B, 40 mg: 3 patients had missing data; Sub-Study B, 120 mg: 1 patient had missing data.

Maximum temperature (Tmax) in the 24-hour period immediately following randomization minus the measured Tmax in the 24-hour period immediately preceding randomization.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=10 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=10 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=14 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Maximum Temperature (Tmax) Response	-1.5 Degrees celcius Interval -3.1 to -0.8	-1.2 Degrees celcius Interval -3.4 to -0.2	-1.5 Degrees celcius Interval -3.1 to 0.5	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days

This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of invasive mechanical ventilation during the course of the patient's COVID-19 infection.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Rate of Non-Elective Invasive Mechanical Ventilation	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: Patients who required non-elective mechanical ventilation

This will be a continuous outcome defined by the amount of time between initiation and cessation of non-elective invasive mechanical ventilation.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Duration of Non-Elective Invasive Mechanical Ventilation	—	—	20 days Interval 16.0 to 21.0	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days

Population: Patients who required non-elective invasive mechanical ventilation

This will be a continuous outcome defined by the amount of time between randomization and the initiation of non-elective invasive mechanical ventilation.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Time to Non-Elective Invasive Mechanical Ventilation	—	—	12 days Interval 5.0 to 18.0	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days

This will be a binary outcome defined as utilization of any vasopressor or inotropic medication.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Rate of Vasopressor/Inotrope Utilization	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Population: Analysis population are patients who required vasopressor or inotrope medication.

This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor medications.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Duration of Vasopressor/Inotrope Utilization	7 days Interval 7.0 to 7.0	—	2 days Interval 1.0 to 8.0	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days

Population: Analysis population are patients who required vasopressor or inotropic medication

This will be a continuous outcome defined by the amount of time between randomization and the initiation of any vasopressor or inotropic medication.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Time to Vasopressor/Inotrope Utilization	14 days Interval 14.0 to 14.0	—	12 days Interval 4.0 to 20.0	—	—	—

SECONDARY outcome

Timeframe: 28 days

This will be an ordinal outcome defined by the number of days counted from randomization over which the participant requires supplemental oxygen in excess over 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 measures
Measure	Sub-study A, Tocilizumab 120mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=26 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=25 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=3 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg n=1 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Clinical Response: Duration of Increased Supplemental Oxygen From Baseline	4.0 days Interval 0.0 to 21.0	5.0 days Interval 0.0 to 19.0	5.7 days Interval 0.0 to 20.0	9.3 days Interval 3.0 to 22.0	7.7 days Interval 3.0 to 15.0	6 days Interval 6.0 to 6.0

SECONDARY outcome

Timeframe: Pre-treatment baseline and 27 +/- 3 hours after tocilizumab administration

Population: 7 patients in study A, SOC had missing data; 8 patients in Study A, 40mg had missing data; 2 patients in Study A, 120 mg had missing data; 1 patient in Study B, SOC had missing data; 1 patient in Study B, 40 mg had missing data; 1 patient in Study B, 120 mg had missing data.

Decline in CRP of ≥ 25% in the 27 +/- 3 hours after tocilizumab administration, as compared to pre-treatment baseline.

Outcome measures

Outcome measures
Measure	Sub-study A, Tocilizumab 120mg n=23 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg	Sub-study A, Tocilizumab-Free Standard of Care n=19 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care	Sub-study A, Tocilizumab 40mg n=17 Participants Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care n=2 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg	Sub-study B, Tocilizumab 40mg n=2 Participants Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg	Sub-study B, Tocilizumab 120mg Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg
Biochemical Response: C-reactive Protein Response Rate	17 Participants	6 Participants	7 Participants	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: 28 days

Population: 5 patients on Study A, SOC had missing data; 1 patient on Study A, 40 mg had missing data; 5 patients on Study !, 120 mg had missing data.

This will be defined as the percentage of patients in a study arm who develop serious non-COVID-19 viral, bacterial, or fungal infections (e.g., bloodstream infection, hospital-acquired pneumonia, ventilator-associated pneumonia, opportunistic infection) following randomization and up to the 28-day assessment of overall survival.