Trial · NCT04362813
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
NCT04362813, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2021-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia. Trials, record NCT04362813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04362813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
- NCT number
- NCT04362813
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 454 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
- Interventions
- Canakinumab, Placebo
- First posted
- 2020-04-27
- Last updated
- 2022-01-24
- Other registries' IDs
- eudract:2020-001370-30
- Results first posted
- 2021-08-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis | Day 3 to Day 29 | Number of responders who survived without requiring invasive mechanical ventilation from Day 3 to Day 29. An early dropout without requiring invasive mechanical ventilation is considered as a responder if discharged from hospital with 9-point ordinal scale\<=1 or with last 9-point ordinal scale on/after Day 15 better than baseline. |
| Secondary | COVID-19-related Death After Study Treatment | 29 days | Participants with COVID-19 related (as assessed by investigator) death up to Day 29 |
| Secondary | Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29. | Measurement of C Reactive Protein (mg/L), Serum Or Plasma over time. The level of C-reactive protein (CRP), which can be measured in the blood, increases when there's inflammation in the body. Lower values of ratio to baseline in the CRP indicates less inflammation. The ratio to baseline at each time point (day) for each patient is calculated as the level of a specific biomarker at the time point divided by the baseline level of the biomarker, where baseline is the last non-missing value before study treatment. The geometric mean of ratio to baseline at each time point for each treatment group is calculated by first averaging the logarithms of the ratios to baseline and then take the exponential function of the same base. |
| Secondary | Geometric Mean Ratio to Baseline in the D-dimer | Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29. | Clinical chemistry measurement D-Dimer (mg/L FEU), Blood in a blood sample over time D-dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. The ratio to baseline at each time point (day) for each patient is calculated as the level of a specific biomarker at the time point divided by the baseline level of the biomarker, where baseline is the last non-missing value before study treatment. The geometric mean of ratio to baseline at each time point for each treatment group is calculated by first averaging the logarithms of the ratios to baseline and then take the exponential function of the same base. |
| Secondary | Geometric Mean Ratio to Baseline in Ferritin | Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29. | Clinical chemistry measurement for amount of ferritin (ug/L) in Serum. The ratio to baseline at each time point (day) for each patient is calculated as the level of a specific biomarker at the time point divided by the baseline level of the biomarker, where baseline is the last non-missing value before study treatment. The geometric mean of ratio to baseline at each time point for each treatment group is calculated by first averaging the logarithms of the ratios to baseline and then take the exponential function of the same base. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Up to day 127 | Number of participants with treatment emergent adverse events, including changes from baseline in vital signs and laboratory results qualifying and reported as adverse events. Safety was monitored from the canakinumab or placebo dose (Day 1) up to 126 days post-dose (Day 127). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis | Day 3 to Day 29 | Randomized participants with at least one assessment of the 9-point ordinal scale between Day 3 and Day 29 (where value 0 = uninfected, and 8 = death) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | COVID-19-related Death After Study Treatment | 29 days | All randomized participants including those who did not receive any dose, as per intent-to-treat principle, and excluding early dropouts if the last available 9-point ordinal scale \>1 (including non-COVID-19 related death) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29. | Randomized participants with a valid assessment for the outcome measure. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Ratio to Baseline in the D-dimer | Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29. | FAS | ratio | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Ratio to Baseline in Ferritin | Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29. | Randomized participants with a valid assessment for the outcome measure. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | Up to day 127 | Safety Set comprises all participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis | Canakinumab | 198 | Participants | ||
| Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis | Placebo | 191 | Participants | ||
| COVID-19-related Death After Study Treatment | Canakinumab | 11 | Participants | ||
| COVID-19-related Death After Study Treatment | Placebo | 16 | Participants | ||
| Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Canakinumab | Day 2 | 0.726 | 95% Confidence Interval 0.671 to 0.786 | ratio |
| Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Placebo | Day 2 | 0.785 | 95% Confidence Interval 0.722 to 0.853 | ratio |
| Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Canakinumab | Day 3 | 0.479 | 95% Confidence Interval 0.430 to 0.534 | ratio |
| Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Placebo | Day 3 | 0.649 | 95% Confidence Interval 0.578 to 0.729 | ratio |
| Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Canakinumab | Day 5 | 0.255 | 95% Confidence Interval 0.222 to 0.292 | ratio |
| Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP) | Placebo | Day 5 | 0.384 | 95% Confidence Interval 0.325 to 0.454 | ratio |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canakinumab | 227 | |
| Overall Study | STARTED | Placebo | 227 | |
| Overall Study | Safety Set | Canakinumab | 225 | |
| Overall Study | Safety Set | Placebo | 223 | |
| Overall Study | Completed Day 29 | Canakinumab | 211 | |
| Overall Study | Completed Day 29 | Placebo | 206 | |
| Overall Study | COMPLETED | Canakinumab | 209 | |
| Overall Study | COMPLETED | Placebo | 202 | |
| Overall Study | NOT COMPLETED | Canakinumab | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 25 |
Source ClinicalTrials.gov
Adverse events202
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 | Anaemia | Blood and lymphatic system disorders | Canakinumab | 6 | 225 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 12 | 223 | |
| other | Hypotension | Vascular disorders | Canakinumab | 12 | 225 | |
| other | Hypotension | Vascular disorders | Placebo | 10 | 223 | |
| serious | Anaemia | Blood and lymphatic system disorders | Canakinumab | 0 | 225 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 223 | |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | Canakinumab | 0 | 225 | |
| serious | Blood loss anaemia | Blood and lymphatic system disorders | Placebo | 2 | 223 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Canakinumab | 1 | 225 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Placebo | 1 | 223 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab | 22 | 225 |
| Total, all-cause mortality | Placebo | 26 | 223 |
| Total, other adverse events | Canakinumab | 15 | 225 |
| Total, other adverse events | Placebo | 19 | 223 |
| Total, serious adverse events | Canakinumab | 47 | 225 |
| Total, serious adverse events | Placebo | 53 | 223 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Canakinumab vs Placebo: Number of Participants With Treatment Emergent Adverse Events | Trial comparisons |
| Canakinumab vs Placebo: COVID-19-related Death After Study Treatment | Trial comparisons |
| Canakinumab vs Placebo: Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis | Trial comparisons |
| Canakinumab vs Placebo: deaths from any cause | Trial comparisons |
| Canakinumab 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/NCT04362813
GET https://conductscience.org/api/trials/v1/NCT04362813/results?page=2