Trial · NCT04447469
Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
NCT04447469, Phase 2, Phase 3, Completed, Kiniksa Pharmaceuticals International, plc; results first posted 2025-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation. Trials, record NCT04447469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04447469
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
- NCT number
- NCT04447469
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 814 participants, actual
- Lead sponsor
- Kiniksa Pharmaceuticals International, plc
- Conditions
- COVID
- Interventions
- mavrilimumab, Placebo
- First posted
- 2020-06-25
- Last updated
- 2025-01-22
- Results first posted
- 2025-01-22
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Day 29 | Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities. |
| Primary | Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Day 29 | Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities. |
| Primary | Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29 | Day 29 | Defined as the proportion of subjects with mechanical ventilation who have died by Day 29. |
| Primary | Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29 | Day 29 | Defined as the proportion of subjects with mechanical ventilation who have died by Day 29. |
| Secondary | Cohort 1, Phase 2: Time to 2-point Clinical Improvement by Day 29 | Day 29 | Defined as time from randomization to a 2-point improvement on the NIAID 8-point ordinal scale, or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30. Kaplan-Meier method used to estimate the survival functions for each treatment arm. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechanical ventilation or ECMO; 3=hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5=hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise); 6=hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7=not hospitalized, limitation on activities and/or requiring home oxygen; 8=not hospitalized, no limitations on activities. |
| Secondary | Phase 2, Cohort 1: Time to Return to Room Air or Discharge by Day 29 | Day 29 | Defined as time from randomization to breathing room air (NIAID score ≥ 5), or discharge from the hospital, whichever came first. Participants who died before Day 29 were censored at Day 30. |
| Secondary | Phase 2, Cohort 1: Percentage of Participants Who Die by Day 29 | Day 29 | 95% CI were calculated using Clopper-Pearson exact method based on the beta distribution. |
| Secondary | Phase 2, Cohort 2: Time to 1-Point Clinical Improvement by Day 29 | Day 29 | Defined as time from randomization to the date of a 1-point improvement on the NIAID score 8-point ordinal scale or discharge from the hospital, whichever occurred first, by Day 29. Participants who did not have 1-point improvement on the NIAID nor discharge from the hospital were censored at the date of the last NIAID 8-point ordinal scale assessment on/before Day 29. Participants who died were censored at Day 32. |
| Secondary | Phase 3, Cohort 1: Percentage of Participants Who Died at Day 29 | Day 29 | Mortality rate at day 29 is the proportion of subjects who die by day 29. 95% CI were calculated using Clopper-Pearson exact method based on the beta distribution. |
| Secondary | Phase 3, Cohort 1: Ventilation-Free Survival (Time to Ventilation or Death) by Day 29 | Day 29 | Time to ventilation or death by Day 29 was defined as time (in days) from randomization to the date of death or start date of using mechanical ventilation (NIAID score ≤ 2) by Day 29. Participants who never had NIAID score ≤ 2 by Day 29 were censored at last assessment date of NIAID 8-point ordinal scale. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Day 29 | Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set). | percentage of participants | NUMBER |
| PRIMARY | Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Day 29 | Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants. | percentage of participants | NUMBER |
| PRIMARY | Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29 | Day 29 | Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set). | percentage of participants | NUMBER |
| PRIMARY | Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29 | Day 29 | Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Cohort 1, Phase 2: Time to 2-point Clinical Improvement by Day 29 | Day 29 | Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set). | days | MEDIAN |
| SECONDARY | Phase 2, Cohort 1: Time to Return to Room Air or Discharge by Day 29 | Day 29 | Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set). | days | MEDIAN |
| SECONDARY | Phase 2, Cohort 1: Percentage of Participants Who Die by Day 29 | Day 29 | Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug (two enrolled and treated participants \[1 each in the 6 mg/kg and placebo groups\] were randomized and dosed in violation of inclusion/exclusion criteria and were thus excluded from this Set). | percentage of participants | NUMBER |
| SECONDARY | Phase 2, Cohort 2: Time to 1-Point Clinical Improvement by Day 29 | Day 29 | Phase 2: Modified Intent-to-Treat (mITT) Analysis Set: All randomized participants who passed screening and received study drug. | days | MEDIAN |
| SECONDARY | Phase 3, Cohort 1: Percentage of Participants Who Died at Day 29 | Day 29 | Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Phase 3, Cohort 1: Ventilation-Free Survival (Time to Ventilation or Death) by Day 29 | Day 29 | Phase 3: Intent-to-Treat (ITT) Analysis Set: All randomized participants. | days | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Phase 2: 10 mg/kg (Cohort 1) | 85.7 | 95% Confidence Interval 69.7 to 95.2 | percentage of participants | |
| Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Phase 2: 6 mg/kg (Cohort 1) | 87.5 | 95% Confidence Interval 73.2 to 95.8 | percentage of participants | |
| Cohort 1, Phase 2: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Phase 2: Placebo (Cohort 1) | 74.4 | 95% Confidence Interval 57.9 to 87.0 | percentage of participants | |
| Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Phase 3: 10 mg/kg (Cohort 1) | 84.3 | 95% Confidence Interval 78.5 to 89.1 | percentage of participants | |
| Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Phase 3: 6 mg/kg (Cohort 1) | 82.8 | 95% Confidence Interval 76.7 to 87.9 | percentage of participants | |
| Cohort 1, Phase 3: Percentage of Participants Alive and Free of Mechanical Ventilation at Day 29 | Phase 3: Placebo (Cohort 1) | 81.3 | 95% Confidence Interval 75.0 to 86.5 | percentage of participants | |
| Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29 | Phase 2: 10 mg/kg (Cohort 2) | 46.7 | 95% Confidence Interval 21.3 to 73.4 | percentage of participants | |
| Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29 | Phase 2: 6 mg/kg (Cohort 2) | 53.3 | 95% Confidence Interval 26.6 to 78.7 | percentage of participants | |
| Cohort 2, Phase 2: Percentage of Participants Who Died by Day 29 | Phase 2: Placebo (Cohort 2) | 47.1 | 95% Confidence Interval 23.0 to 72.2 | percentage of participants | |
| Cohort 2, Phase 3: Percentage of Participants Who Died by Day 29 | Phase 3: 10 mg/kg (Cohort 2) | 40.0 | 95% Confidence Interval 19.1 to 63.9 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 2: 10 mg/kg (Cohort 1) | 37 | |
| Overall Study | STARTED | Phase 2: 6 mg/kg (Cohort 1) | 42 | |
| Overall Study | STARTED | Phase 2: Placebo (Cohort 1) | 41 | |
| Overall Study | STARTED | Phase 2: 10 mg/kg (Cohort 2) | 18 | |
| Overall Study | STARTED | Phase 2: 6 mg/kg (Cohort 2) | 15 | |
| Overall Study | STARTED | Phase 2: Placebo (Cohort 2) | 17 | |
| Overall Study | STARTED | Phase 3: 10 mg/kg (Cohort 1) | 198 | |
| Overall Study | STARTED | Phase 3: 6 mg/kg (Cohort 1) | 192 | |
| Overall Study | STARTED | Phase 3: Placebo (Cohort 1) | 192 | |
| Overall Study | STARTED | Phase 3: 10 mg/kg (Cohort 2) | 20 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events6,144
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 | Phase 2: 10 mg/kg (Cohort 1) | 0 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: 6 mg/kg (Cohort 1) | 1 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Placebo (Cohort 1) | 0 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: 10 mg/kg (Cohort 2) | 1 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: 6 mg/kg (Cohort 2) | 0 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Placebo (Cohort 2) | 0 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: 10 mg/kg (Cohort 1) | 11 | 195 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: 6 mg/kg (Cohort 1) | 5 | 188 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: Placebo (Cohort 1) | 5 | 191 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: 10 mg/kg (Cohort 2) | 2 | 20 |
1 to 10 of 6,144Source ClinicalTrials.gov
See all 6,144 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 2: 10 mg/kg (Cohort 1) | 4 | 35 |
| Total, all-cause mortality | Phase 2: 6 mg/kg (Cohort 1) | 5 | 41 |
| Total, all-cause mortality | Phase 2: Placebo (Cohort 1) | 9 | 40 |
| Total, all-cause mortality | Phase 2: 10 mg/kg (Cohort 2) | 7 | 15 |
| Total, all-cause mortality | Phase 2: 6 mg/kg (Cohort 2) | 9 | 15 |
| Total, all-cause mortality | Phase 2: Placebo (Cohort 2) | 9 | 17 |
| Total, all-cause mortality | Phase 3: 10 mg/kg (Cohort 1) | 20 | 195 |
| Total, all-cause mortality | Phase 3: 6 mg/kg (Cohort 1) | 30 | 188 |
| Total, all-cause mortality | Phase 3: Placebo (Cohort 1) | 30 | 191 |
| Total, all-cause mortality | Phase 3: 10 mg/kg (Cohort 2) | 7 | 20 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04447469
GET https://conductscience.org/api/trials/v1/NCT04447469/results?page=2