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

Last Updated: 2025-06-05

Results Overview

Day of recovery is defined as the first day on which the patient achieves one of the following two categories from the 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

2025-06-05

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=5 Participants	56.5 years n=7 Participants	59.2 years n=5 Participants	49.7 years n=4 Participants	53.3 years n=21 Participants	72 years n=10 Participants	57.5 years n=115 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	45 Participants n=115 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	38 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	73 Participants n=115 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Region of Enrollment United States	26 participants n=5 Participants	25 participants n=7 Participants	25 participants n=5 Participants	3 participants n=4 Participants	3 participants n=21 Participants	1 participants n=10 Participants	83 participants n=115 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-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
Time to Recovery	5 days Interval 4.0 to 6.0	7 days Interval 4.0 to 9.0	4 days Interval 4.0 to 5.0	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 in a given arm of the study achieving one of the above two categories on the ordinal scale on day 7. 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 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 data not reported

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 data not reported

SECONDARY outcome

Timeframe: 24 hours

Maximum temperature within 24-hour periods of time immediately prior to, immediately following, and then every 24 hours thereafter randomization. The primary endpoint is a measured Tmax in the 24-hour period immediately following randomization that is lower than the measured Tmax in the 24-hour period immediately preceding randomization.

Outcome measures

Outcome data not reported

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 data not reported

SECONDARY outcome

Timeframe: Up to 28 days

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 data not reported

SECONDARY outcome

Timeframe: Up to 28 days

This will be a continuous outcome defined by the amount of time between randomization and the initiation of non-elective invasive mechanical ventilation. This will be treated as a time-to-event with possible censoring.

Outcome measures

Outcome data not reported

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 data not reported

SECONDARY outcome

Timeframe: Up to 28 days

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 data not reported

SECONDARY outcome

Timeframe: Up to 28 days

This will be a continuous outcome defined by the amount of time between randomization and the initiation of any vasopressor or inotropic medication. This will be treated as a time-to-event with possible censoring.

Outcome measures

Outcome data not reported

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 data not reported

SECONDARY outcome

Timeframe: 24 hours

This will be a binary outcome defined as the presence or absence of a decline in CRP of ≥ 25% from baseline CRP in the 27 +/- 3 hours after tocilizumab administration, as compared to pre-treatment baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

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.