Trial Outcomes & Findings for Tocilizumab for Patients With Cancer and COVID-19 Disease (NCT NCT04370834)

Last Updated: 2025-02-04

Results Overview

7-category Clinical Status Ordinal Scale: 1. Discharge 2. Non-ICU, hospital ward, No O2 3. Non-ICU, hospital ward, on O2 4. ICU or non-ICU, requires non-invasive ventilatory support or high flow O2 5. ICU requires mechanical or imminent ventilation/intubation 6. ICU requires ECMO and additional O2 support and organ support, e.g. vasopressors, renal replacement therapy 7. Death

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Day 14 after tocilizumab administration

Results posted on

2025-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Other (Tocilizumab) Patients receive tocilizumab IV over 60 minutes. A second dose may be given if there is sustained or recurrent fever, no decrease or not more than a 1-category improvement on the 7-category ordinal scale (only stabilization or partial improvement following first dose), or a \>= 1-category worsening on the 7-category ordinal scale from nadir. Tocilizumab: Given IV
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tocilizumab for Patients With Cancer and COVID-19 Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Other (Tocilizumab) n=1 Participants Patients receive tocilizumab IV over 60 minutes. A second dose may be given if there is sustained or recurrent fever, no decrease or not more than a 1-category improvement on the 7-category ordinal scale (only stabilization or partial improvement following first dose), or a \>= 1-category worsening on the 7-category ordinal scale from nadir. Tocilizumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Cohort Cohort A1	1 Participants n=5 Participants
Cohort Cohort A2	0 Participants n=5 Participants
Cohort Cohort B1	0 Participants n=5 Participants
Cohort Cohort B2	0 Participants n=5 Participants
Cancer type Hematologic	1 Participants n=5 Participants
Cancer type Solid tumor	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14 after tocilizumab administration

Population: No patients were accrued to Cohorts A2, B1, or B2.

Outcome measures

Outcome measures
Measure	Cohort A1 n=1 Participants Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, At least 30 kg	Cohort A2 Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, Less than 30 kg	Cohort B1 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, At least 30 kg	Cohort B2 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, Less than 30 kg
Number of Participants With at Least 1 Point Reduction in Score on 7-category Clinical Status Ordinal Scale	1 Participants	—	—	—

Adverse Events

Cohort A1

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Cohort A2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort B1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort B2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A1 n=1 participants at risk Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, At least 30 kg	Cohort A2 Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, Less than 30 kg	Cohort B1 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, At least 30 kg	Cohort B2 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, Less than 30 kg
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 1 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.
Infections and infestations Sepsis	100.0% 1/1 • Number of events 1 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.
General disorders Death	100.0% 1/1 • Number of events 1 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.

Other adverse events

Other adverse events
Measure	Cohort A1 n=1 participants at risk Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, At least 30 kg	Cohort A2 Clinical Status Ordinal Scale 3-4, Not on mechanical ventilation at time of registration and no immediate plan for intubation, Less than 30 kg	Cohort B1 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, At least 30 kg	Cohort B2 Clinical Status Ordinal Scale 5-6, On mechanical ventilation at time of enrollment or imminent intubation indicated, Less than 30 kg
Investigations Alanine aminotransferase increased	100.0% 1/1 • Number of events 1 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Number of events 1 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.
Investigations Blood bilirubin increased	100.0% 1/1 • Number of events 1 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.	— 0/0 • 30 days after tocilizumab administration One patient was enrolled to this trial. This patient enrolled to Cohort A1.

Additional Information

Dr. Richard Little, Principal Investigator

National Cancer Institute

Phone: 240-276-6093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60