Trial · NCT04356937
Efficacy of Tocilizumab on Patients With COVID-19
NCT04356937, Phase 3, Completed, Massachusetts General Hospital; results first posted 2021-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Tocilizumab on Patients With COVID-19. Trials, record NCT04356937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04356937
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Tocilizumab on Patients With COVID-19
- NCT number
- NCT04356937
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 243 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- SARS-CoV 2
- Interventions
- Tocilizumab, Placebos
- First posted
- 2020-04-22
- Last updated
- 2021-07-27
- Results first posted
- 2021-07-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mechanical Ventilation or Death | 28 days | Time from administration of the investigational agent (or placebo) to requiring mechanical ventilation and intubation, or death for subjects who die prior to intubation. The percentages of patients who have been intubated or died as of day 14 and day 28 are estimated from the Kaplan-Meier curve. |
| Secondary | Clinical Worsening on Ordinal Scale | 28 days | Time from administration of the investigational medication (or placebo) to at least one point worsening on the clinical improvement scale for subjects requiring supplemental oxygen (score \>= 3) at baseline, or at least two point worsening otherwise (score = 2 at baseline). The percentages of patients who have worsened as of day 14 and day 28 are estimated from the Kaplan-Meier curve. Ordinal Scale 1. Discharged 2. Non-ICU hospital ward not requiring supplemental oxygen 3. Non-ICU hospital ward requiring supplemental oxygen 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. ICU, requiring intubation and mechanical ventilation 6. ICU, requiring ECMO or mechanical ventilation and additional organ support 7. Death |
| Secondary | Discontinuation of Supplemental Oxygen Among Patients Receiving it at Baseline | 28 days | Time from administration of the investigational agent (or placebo) to absence of the need for supplemental oxygen among those who require at least supplemental oxygen at baseline. The percentages of patients who have discontinued supplemental oxygen as of day 14 and day 28 are estimated from the Kaplan-Meier curve. |
| Other | Duration of Supplemental Oxygen | 28 days | Time from initiation of supplemental oxygen to end of supplemental oxygen use during 28-day study follow-up period. We includes all subjects in the analysis by assigning all subjects who did not receive supplemental oxygen a value of 0. Subjects who died prior to discontinuation of supplemental oxygen were given a value of the number of days from when supplemental oxygen began until the end of the follow-up period. |
| Other | Duration of Mechanical Ventilation | 28 days | Time from initiation of mechanical ventilation to end of mechanical ventilation during 28-day study follow-up period, among patients who received mechanical ventilation. Event times of patients who died without discontinuation of mechanical ventilation were censored at 28 days. Median and inter-quartile range (IQR) were estimated using Kaplan-Meier curves. The upper limit for the IQR was not reached for both arms and entered as 28 in the outcome measure data table. |
| Other | Mortality | 28 days | Time from administration of the investigational agent (or placebo) to death. The percentage of patients who have died as of day 14 and day 28 are estimated from the Kaplan-Meier curve. |
| Other | ICU Admission or Death Among Those Not in the ICU at the Time of Administration of Investigational Agent (or Placebo) | 28 days | The percentage of subjects requiring ICU admission between baseline and 28 days is calculated by dividing the number of subjects requiring ICU admission over their hospitalization by the number of evaluable subjects (i.e., the number of subjects not in the ICU at the time of investigational treatment administration). |
| Other | Hospital Discharge | 28 days | Time from administration of the investigational medication (or placebo) to initial hospital discharge. Event times for patient who die are censored at day 29 to indicate that they never left the hospital during the follow-up period. The percentages of patients who were discharged as of day 14 and day 28 are estimated from the Kaplan-Meier curve. |
| Other | Clinical Improvement on Ordinal Scale | 28 days | Time to first improvement from administration of the investigational agent (or placebo) of at least 2 points (or the maximum amount) on the ordinal scale. Event times for patients who died prior to reaching this endpoint are censored at 29 days. Ordinal Scale 1. Discharged 2. Non-ICU hospital ward not requiring supplemental oxygen 3. Non-ICU hospital ward requiring supplemental oxygen 4. ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. ICU, requiring intubation and mechanical ventilation 6. ICU, requiring ECMO or mechanical ventilation and additional organ support 7. Death |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mechanical Ventilation or Death | 28 days | Modified intention-to-treat (mITT) population, which includes 242 patients (161 in the tocilizumab group and 81 in the placebo group) who underwent randomization and received either tocilizumab or placebo before intubation or death | percentage of patients with event | NUMBER |
| SECONDARY | Clinical Worsening on Ordinal Scale | 28 days | Modified intention-to-treat (mITT) population, which includes 242 patients (161 in the tocilizumab group and 81 in the placebo group) who underwent randomization and received either tocilizumab or placebo before intubation or death | percentage of patients with event | NUMBER |
| SECONDARY | Discontinuation of Supplemental Oxygen Among Patients Receiving it at Baseline | 28 days | A subset of 204 patients from the modified intention-to-treat (mITT) population who required at least supplemental oxygen at baseline. 138 patients in the tocilizumab group and 66 patients in the placebo group required at least supplemental oxygen at baseline. | percentage of patients with event | NUMBER |
| OTHER_PRE_SPECIFIED | Duration of Supplemental Oxygen | 28 days | Modified intention-to-treat (mITT) population, which includes 242 patients (161 in the tocilizumab group and 81 in the placebo group) who underwent randomization and received either tocilizumab or placebo before intubation or death | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Duration of Mechanical Ventilation | 28 days | A subset of 19 patients from the modified intention-to-treat (mITT) population who received mechanical ventilation during the study follow-up period. 11 patients in the tocilizumab group and 8 patients in the placebo group received mechanical ventilation. | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Mortality | 28 days | Modified intention-to-treat (mITT) population, which includes 242 patients (161 in the tocilizumab group and 81 in the placebo group) who underwent randomization and received either tocilizumab or placebo before intubation or death | percentage of patients with event | NUMBER |
| OTHER_PRE_SPECIFIED | ICU Admission or Death Among Those Not in the ICU at the Time of Administration of Investigational Agent (or Placebo) | 28 days | A subset of 233 patients from the modified intention-to-treat (mITT) population who were not in the ICU at baseline. 157 patients in the tocilizumab group and 76 patients in the placebo group were not in the ICU at baseline. | percentage of patients with event | NUMBER |
| OTHER_PRE_SPECIFIED | Hospital Discharge | 28 days | Modified intention-to-treat (mITT) population, which includes 242 patients (161 in the tocilizumab group and 81 in the placebo group) who underwent randomization and received either tocilizumab or placebo before intubation or death | percentage of patients with event | NUMBER |
| OTHER_PRE_SPECIFIED | Clinical Improvement on Ordinal Scale | 28 days | Modified intention-to-treat (mITT) population, which includes 242 patients (161 in the tocilizumab group and 81 in the placebo group) who underwent randomization and received either tocilizumab or placebo before intubation or death | percentage of patients with event | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mechanical Ventilation or Death | Tocilizumab | 14 days | 9.9 | 95% Confidence Interval 6.2 to 15.7 | percentage of patients with event |
| Mechanical Ventilation or Death | Placebo | 14 days | 10.0 | 95% Confidence Interval 5.1 to 18.9 | percentage of patients with event |
| Mechanical Ventilation or Death | Tocilizumab | 28 days | 10.6 | 95% Confidence Interval 6.7 to 16.6 | percentage of patients with event |
| Mechanical Ventilation or Death | Placebo | 28 days | 12.5 | 95% Confidence Interval 6.9 to 22.0 | percentage of patients with event |
| Clinical Worsening on Ordinal Scale | Tocilizumab | Day 14 | 18.0 | 95% Confidence Interval 12.9 to 24.9 | percentage of patients with event |
| Clinical Worsening on Ordinal Scale | Placebo | Day 14 | 14.9 | 95% Confidence Interval 8.7 to 24.7 | percentage of patients with event |
| Clinical Worsening on Ordinal Scale | Tocilizumab | Day 28 | 19.3 | 95% Confidence Interval 14.0 to 26.2 | percentage of patients with event |
| Clinical Worsening on Ordinal Scale | Placebo | Day 28 | 17.4 | 95% Confidence Interval 10.7 to 27.7 | percentage of patients with event |
| Discontinuation of Supplemental Oxygen Among Patients Receiving it at Baseline | Tocilizumab | Day 14 | 75.4 | 95% Confidence Interval 67.9 to 82.2 | percentage of patients with event |
| Discontinuation of Supplemental Oxygen Among Patients Receiving it at Baseline | Placebo | Day 14 | 78.8 | 95% Confidence Interval 68.3 to 87.7 | percentage of patients with event |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization (Safety Population) | STARTED | Tocilizumab | 161 | |
| Randomization (Safety Population) | STARTED | Placebo | 82 | |
| Randomization (Safety Population) | COMPLETED | Tocilizumab | 161 | |
| Randomization (Safety Population) | COMPLETED | Placebo | 82 | |
| Randomization (Safety Population) | NOT COMPLETED | Tocilizumab | 0 | |
| Randomization (Safety Population) | NOT COMPLETED | Placebo | 0 | |
| Treatment (mITT Population) | STARTED | Tocilizumab | 161 | |
| Treatment (mITT Population) | STARTED | Placebo | 82 | |
| Treatment (mITT Population) | COMPLETED | Tocilizumab | 161 | |
| Treatment (mITT Population) | COMPLETED | Placebo | 81 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events122
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 | Acute kidney injury | Renal and urinary disorders | Tocilizumab | 1 | 161 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Placebo | 0 | 81 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Tocilizumab | 1 | 161 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 2 | 81 | 2 |
| other | Bradycardia | Cardiac disorders | Tocilizumab | 1 | 161 | 1 |
| other | Bradycardia | Cardiac disorders | Placebo | 0 | 81 | 0 |
| other | Conjunctivitis | Eye disorders | Tocilizumab | 1 | 161 | 1 |
| other | Conjunctivitis | Eye disorders | Placebo | 0 | 81 | 0 |
| other | Decreased poly(ADP-ribosyl)ation | Immune system disorders | Tocilizumab | 1 | 161 | 1 |
| other | Decreased poly(ADP-ribosyl)ation | Immune system disorders | Placebo | 0 | 81 | 0 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tocilizumab | 9 | 161 |
| Total, all-cause mortality | Placebo | 4 | 82 |
| Total, other adverse events | Tocilizumab | 20 | 161 |
| Total, other adverse events | Placebo | 26 | 81 |
| Total, serious adverse events | Tocilizumab | 19 | 161 |
| Total, serious adverse events | Placebo | 8 | 82 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33085857 | DERIVED |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tocilizumab vs Placebo: deaths from any cause | Trial comparisons |
| Tocilizumab vs Placebo: 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.
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/NCT04356937
GET https://conductscience.org/api/trials/v1/NCT04356937/results?page=2