Trial · NCT04369469
Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
NCT04369469, Phase 3, Terminated, Alexion Pharmaceuticals, Inc.; results first posted 2022-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia. Trials, record NCT04369469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04369469
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
- NCT number
- NCT04369469
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 202 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- COVID-19 Severe Pneumonia, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Viral
- Interventions
- Ravulizumab, BSC
- First posted
- 2020-04-30
- Last updated
- 2022-05-24
- Results first posted
- 2022-05-24
- Limitations and caveats
Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 | Day 29 | Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations. |
| Secondary | Number Of Days Free Of Mechanical Ventilation At Day 29 | Day 29 | The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation. |
| Secondary | Number of Days the Participants Were Alive and Not in ICU | Day 1 through Day 29 | The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented. |
| Secondary | Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29 | Baseline, Day 29 | Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition. |
| Secondary | Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29 | Baseline, Day 29 | Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point. |
| Secondary | Number of Days the Participants Were Alive and Not in the Hospital | Day 1 through Day 29 | The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented. |
| Secondary | Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90 | Up to Day 60 and Up to Day 90 | For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section. |
| Secondary | Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29 | Day 1 and Day 29 | Results are reported in micrograms/milliliter (μg/mL). |
| Secondary | Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29 | Baseline, Day 29 | |
| Secondary | Change From Baseline In Terminal Complement Complex C5b-9 At Day 29 | Baseline, Day 29 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 | Day 29 | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. | Percentage of participants | NUMBER |
| SECONDARY | Number Of Days Free Of Mechanical Ventilation At Day 29 | Day 29 | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Days | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Days the Participants Were Alive and Not in ICU | Day 1 through Day 29 | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Days | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29 | Baseline, Day 29 | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29 | Baseline, Day 29 | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | ratio | MEAN |
| SECONDARY | Number of Days the Participants Were Alive and Not in the Hospital | Day 1 through Day 29 | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Days | LEAST_SQUARES_MEAN |
| SECONDARY | Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90 | Up to Day 60 and Up to Day 90 | The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, Number Analyzed signifies those participants who were evaluable for the assessment at the specified time frame. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29 | Day 1 and Day 29 | Pharmacokinetics/Pharmacodynamics (PK/PD) Population: participants in the ITT population with at least 1 postdose PK or PD result. | μg/mL | MEAN |
| SECONDARY | Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29 | Baseline, Day 29 | PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | μg/mL | MEAN |
| SECONDARY | Change From Baseline In Terminal Complement Complex C5b-9 At Day 29 | Baseline, Day 29 | PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | ug/L | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 | Group 1 - Ravulizumab + BSC | 57.6 | Percentage of participants | ||
| Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29 | Group 2 - BSC Alone | 59.7 | Percentage of participants | ||
| Number Of Days Free Of Mechanical Ventilation At Day 29 | Group 1 - Ravulizumab + BSC | 6.79 | 95% Confidence Interval 4.79 to 8.80 | Days | |
| Number Of Days Free Of Mechanical Ventilation At Day 29 | Group 2 - BSC Alone | 6.81 | 95% Confidence Interval 4.19 to 9.43 | Days | |
| Number of Days the Participants Were Alive and Not in ICU | Group 1 - Ravulizumab + BSC | 6.09 | 95% Confidence Interval 4.31 to 7.87 | Days | |
| Number of Days the Participants Were Alive and Not in ICU | Group 2 - BSC Alone | 6.71 | 95% Confidence Interval 4.38 to 9.03 | Days | |
| Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29 | Group 1 - Ravulizumab + BSC | -2.0 | Standard Deviation 6.25 | Units on a scale | |
| Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29 | Group 2 - BSC Alone | -4.5 | Standard Deviation 4.90 | Units on a scale | |
| Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29 | Group 1 - Ravulizumab + BSC | 62.5 | Standard Deviation 112.43 | ratio | |
| Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29 | Group 2 - BSC Alone | 134.0 | Standard Deviation 104.35 | ratio |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 - Ravulizumab + BSC | 135 | |
| Overall Study | STARTED | Group 2 - BSC Alone | 67 | |
| Overall Study | Intent to Treat (ITT) Population | Group 1 - Ravulizumab + BSC | 135 | |
| Overall Study | Intent to Treat (ITT) Population | Group 2 - BSC Alone | 66 | |
| Overall Study | Pharmacokinetic (PK) | Group 1 - Ravulizumab + BSC | 127 | |
| Overall Study | Pharmacokinetic (PK) | Group 2 - BSC Alone | 52 | |
| Overall Study | Safety Population | Group 1 - Ravulizumab + BSC | 127 | |
| Overall Study | Safety Population | Group 2 - BSC Alone | 67 | |
| Overall Study | COMPLETED | Group 1 - Ravulizumab + BSC | 125 | |
| Overall Study | COMPLETED | Group 2 - BSC Alone | 58 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | Hypotension | Vascular disorders | Group 1 - Ravulizumab + BSC | 16 | 127 | 18 |
| other | Hypotension | Vascular disorders | Group 2 - BSC Alone | 8 | 67 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Group 1 - Ravulizumab + BSC | 13 | 127 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Group 2 - BSC Alone | 4 | 67 | 5 |
| other | Atrial fibrillation | Cardiac disorders | Group 1 - Ravulizumab + BSC | 12 | 127 | 12 |
| other | Atrial fibrillation | Cardiac disorders | Group 2 - BSC Alone | 5 | 67 | 5 |
| other | Pyrexia | General disorders | Group 1 - Ravulizumab + BSC | 10 | 127 | 12 |
| other | Pyrexia | General disorders | Group 2 - BSC Alone | 6 | 67 | 6 |
| other | Deep vein thrombosis | Vascular disorders | Group 1 - Ravulizumab + BSC | 14 | 127 | 14 |
| other | Deep vein thrombosis | Vascular disorders | Group 2 - BSC Alone | 2 | 67 | 2 |
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 | Group 1 - Ravulizumab + BSC | 55 | 135 |
| Total, all-cause mortality | Group 2 - BSC Alone | 25 | 66 |
| Total, other adverse events | Group 1 - Ravulizumab + BSC | 97 | 127 |
| Total, other adverse events | Group 2 - BSC Alone | 49 | 67 |
| Total, serious adverse events | Group 1 - Ravulizumab + BSC | 79 | 127 |
| Total, serious adverse events | Group 2 - BSC Alone | 38 | 67 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 - Ravulizumab + BSC vs Group 2 - BSC Alone: deaths from any cause | Trial comparisons |
| Group 1 - Ravulizumab + BSC vs Group 2 - BSC Alone: 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/NCT04369469
GET https://conductscience.org/api/trials/v1/NCT04369469/results?page=2