Trial · NCT04331795

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

NCT04331795, Phase 2, Completed, University of Chicago; results first posted 2022-06-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis. Trials, record NCT04331795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04331795

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis
NCT number: NCT04331795
Status: Completed
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: University of Chicago
Conditions: COVID-19
Interventions: Tocilizumab, Tocilizumab
First posted: 2020-04-02
Last updated: 2022-06-09
Results first posted: 2022-06-09

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinical Response in Maximum Temperature (Tmax)	Assessed for the 24 hour period after tocilizumab administration	Number of Participants with Clinical Response in Maximum Temperature (Tmax)
Primary	Number of Participants With Biochemical Response as Determined by CRP Response	Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration	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.
Secondary	Overall Survival	28 days	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.
Secondary	Survival to Hospital Discharge	Hospitalization, up to 4 weeks after tocilizumab administration	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.
Secondary	Progression of COVID-19 Pneumonitis	Hospitalization, up to 4 weeks after tocilizumab administration	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).
Secondary	Rate of Non-elective Mechanical Ventilation	Hospitalization, up to 4 weeks after tocilizumab administration	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.
Secondary	Duration of Mechanical Ventilation	Hospitalization, up to 4 weeks after tocilizumab administration	This will be a continuous outcome defined by the amount of time between initiation and cessation of mechanical ventilation (invasive and non-invasive).
Secondary	Time to Mechanical Ventilation	Assessed over hospitalization, up to 4 weeks after tocilizumab administration	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.
Secondary	Rate of Vasopressor/Inotrope Utilization	Hospitalization, up to 4 weeks after tocilizumab administration	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.
Secondary	Duration of Vasopressor/Inotrope Utilization	Hospitalization, up to 4 weeks after tocilizumab administration	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).

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Clinical Response in Maximum Temperature (Tmax)	Assessed for the 24 hour period after tocilizumab administration		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Biochemical Response as Determined by CRP Response	Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration	One patient in Group A and 2 patients in Group B were deceased before measure of CRP.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Survival to Hospital Discharge	Hospitalization, up to 4 weeks after tocilizumab administration		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression of COVID-19 Pneumonitis	Hospitalization, up to 4 weeks after tocilizumab administration	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.
SECONDARY	Rate of Non-elective Mechanical Ventilation	Hospitalization, up to 4 weeks after tocilizumab administration		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Mechanical Ventilation	Hospitalization, up to 4 weeks after tocilizumab administration		days	MEDIAN
SECONDARY	Time to Mechanical Ventilation	Assessed over hospitalization, up to 4 weeks after tocilizumab administration		days	MEDIAN
SECONDARY	Rate of Vasopressor/Inotrope Utilization	Hospitalization, up to 4 weeks after tocilizumab administration	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.
SECONDARY	Duration of Vasopressor/Inotrope Utilization	Hospitalization, up to 4 weeks after tocilizumab administration	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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Clinical Response in Maximum Temperature (Tmax)	Group A	8	Participants
Number of Participants With Clinical Response in Maximum Temperature (Tmax)	Group B	16	Participants
Number of Participants With Biochemical Response as Determined by CRP Response	Group A	10	Participants
Number of Participants With Biochemical Response as Determined by CRP Response	Group B	15	Participants
Overall Survival	Group A	10	Participants
Overall Survival	Group B	17	Participants
Survival to Hospital Discharge	Group A	1	Participants
Survival to Hospital Discharge	Group B	2	Participants
Rate of Non-elective Mechanical Ventilation	Group A	2	Participants
Rate of Non-elective Mechanical Ventilation	Group B	4	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group A	12
Overall Study	STARTED	Group B	20
Overall Study	COMPLETED	Group A	12
Overall Study	COMPLETED	Group B	20
Overall Study	NOT COMPLETED	Group A	0
Overall Study	NOT COMPLETED	Group B	0

Source ClinicalTrials.gov

Adverse events102

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Group A	1	12	1
other	Anemia	Blood and lymphatic system disorders	Group B	1	20	1
other	QTC prolangulation	Cardiac disorders	Group A	0	12	0
other	QTC prolangulation	Cardiac disorders	Group B	1	20	1
other	Type II NSTEMO	Cardiac disorders	Group A	1	12	1
other	Type II NSTEMO	Cardiac disorders	Group B	0	20	0
other	Atrial Flutter	Cardiac disorders	Group A	0	12	0
other	Atrial Flutter	Cardiac disorders	Group B	1	20	1
other	Chest pain	Cardiac disorders	Group A	1	12	1
other	Chest pain	Cardiac disorders	Group B	1	20	1

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group A	2	12
Total, all-cause mortality	Group B	3	20
Total, other adverse events	Group A	9	12
Total, other adverse events	Group B	17	20
Total, serious adverse events	Group A	0	12
Total, serious adverse events	Group B	0	20

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33210302	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Group A vs Group B: Overall Survival	Trial comparisons
Group A vs Group B: Rate of Non-elective Mechanical Ventilation	Trial comparisons
Group A vs Group B: Survival to Hospital Discharge	Trial comparisons
Group A vs Group B: deaths from any cause	Trial comparisons
Group A vs Group B: Number of Participants With Clinical Response in Maximum Temperature (Tmax)	Trial comparisons
Group A vs Group B: Number of Participants With Biochemical Response as Determined by CRP Response	Trial comparisons
Group A vs Group B: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04331795

GET https://conductscience.org/api/trials/v1/NCT04331795/events?page=2

API reference For AI assistants