Trial · NCT04382755
Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure
NCT04382755, Phase 2, Completed, University Hospital, Ghent; results first posted 2023-09-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure. Trials, record NCT04382755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04382755
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zilucoplan® in Improving Oxygenation, Short-, Longterm Outcome of COVID19 Patients With Acute Hypoxic Respiratory Failure
- NCT number
- NCT04382755
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- University Hospital, Ghent
- Conditions
- COVID-19
- Interventions
- Zilucoplan®, Placebo
- First posted
- 2020-05-11
- Last updated
- 2023-09-14
- Results first posted
- 2023-09-14
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Oxygenation | at predose, day 6 and day 15 (or at discharge, whichever comes first) | defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio |
| Secondary | Mean Change in 6-point Ordinal Scale Change for Clinical Improvement | between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call). | 6-point ordinal scale defined as 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen 6. Not hospitalized |
| Secondary | Number of Days With Hypoxia | during hospital admission (up to 28 days) | defined as SpO2 \< 93% breathing room air or the dependence on supplemental oxygen |
| Secondary | Number of Days of Supplemental Oxygen Use | during hospital admission (up to 28 days) | |
| Secondary | Time to Absence of Fever (Defined as 37.1°C or More) for More Than 48h Without Antipyretic | during hospital admission (up to 28 days) | |
| Secondary | Number of Days With Fever | during hospital admission (up to 28 days) | defined as 37.1°C or more |
| Secondary | Mean Change in CRP Levels Between Day 1 and Day 6 | day 1, day 6 | |
| Secondary | Mean Change in CRP Levels Between Day 1 and Day 15 (or Discharge Whichever Comes First) | day 1, day 15 | |
| Secondary | Mean Change in Ferritin Levels Between Day 1 and Day 6 | day 1, day 6 | |
| Secondary | Mean Change in Ferritin Levels Between Day 1 and Day 15 (or Discharge, Whichever Comes First) | day 1, day 15 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Oxygenation | at predose, day 6 and day 15 (or at discharge, whichever comes first) | mmHg | LEAST_SQUARES_MEAN | |
| PRIMARY | Change in Oxygenation | at predose, day 6 and day 15 (or at discharge, whichever comes first) | mmHg | GEOMETRIC_LEAST_SQUARES_MEAN | |
| SECONDARY | Mean Change in 6-point Ordinal Scale Change for Clinical Improvement | between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call). | score on a scale | MEAN | |
| SECONDARY | Number of Days With Hypoxia | during hospital admission (up to 28 days) | days | MEDIAN | |
| SECONDARY | Number of Days of Supplemental Oxygen Use | during hospital admission (up to 28 days) | days | MEDIAN | |
| SECONDARY | Time to Absence of Fever (Defined as 37.1°C or More) for More Than 48h Without Antipyretic | during hospital admission (up to 28 days) | days | MEDIAN | |
| SECONDARY | Number of Days With Fever | during hospital admission (up to 28 days) | days | MEDIAN | |
| SECONDARY | Mean Change in CRP Levels Between Day 1 and Day 6 | day 1, day 6 | mg/mL | MEAN | |
| SECONDARY | Mean Change in CRP Levels Between Day 1 and Day 15 (or Discharge Whichever Comes First) | day 1, day 15 | mg/mL | MEAN | |
| SECONDARY | Mean Change in Ferritin Levels Between Day 1 and Day 6 | day 1, day 6 | µg/L | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Oxygenation | Group A (Active) | change from baseline in PaO2/FiO2 day 6 | 56.4 | 95% Confidence Interval 31.9 to 80.9 | mmHg |
| Change in Oxygenation | Group B (Control) | change from baseline in PaO2/FiO2 day 6 | 20.6 | 95% Confidence Interval 17.3 to 58.5 | mmHg |
| Change in Oxygenation | Group A (Active) | change from baseline in PaO2/FiO2 day 15 | 123.5 | 95% Confidence Interval 94.3 to 152.7 | mmHg |
| Change in Oxygenation | Group B (Control) | change from baseline in PaO2/FiO2 day 15 | 83.7 | 95% Confidence Interval 39.0 to 128.4 | mmHg |
| Change in Oxygenation | Group A (Active) | change from baseline in a/A PO2 day 6 | 0.10 | 95% Confidence Interval 0.06 to 0.15 | mmHg |
| Change in Oxygenation | Group B (Control) | change from baseline in a/A PO2 day 6 | 0.04 | 95% Confidence Interval 0.04 to 0.11 | mmHg |
| Change in Oxygenation | Group A (Active) | change from baseline in a/A PO2 day 15 | 0.25 | 95% Confidence Interval 0.19 to 0.31 | mmHg |
| Change in Oxygenation | Group B (Control) | change from baseline in a/A PO2 day 15 | 0.17 | 95% Confidence Interval 0.08 to 0.26 | mmHg |
| Change in Oxygenation | Group A (Active) | (A-a) gradient day 6 | 114.6 | 95% Confidence Interval 92.6 to 141.9 | mmHg |
| Change in Oxygenation | Group B (Control) | (A-a) gradient day 6 | 146.7 | 95% Confidence Interval 105.4 to 204.3 | mmHg |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A (Active) | 55 | |
| Overall Study | STARTED | Group B (Control) | 26 | |
| Overall Study | Treated | Group A (Active) | 54 | |
| Overall Study | Treated | Group B (Control) | 24 | |
| Overall Study | COMPLETED | Group A (Active) | 54 | |
| Overall Study | COMPLETED | Group B (Control) | 24 | |
| Overall Study | NOT COMPLETED | Group A (Active) | 1 | |
| Overall Study | NOT COMPLETED | Group B (Control) | 2 |
Source ClinicalTrials.gov
Adverse events64
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 | hypertension | Vascular disorders | Group A (Active) | 8 | 54 | |
| other | hypertension | Vascular disorders | Group B (Control) | 2 | 24 | |
| other | alanine animontransferase increased | Investigations | Group A (Active) | 4 | 54 | |
| other | alanine animontransferase increased | Investigations | Group B (Control) | 1 | 24 | |
| other | aspartate animontransferase increased | Investigations | Group A (Active) | 3 | 54 | |
| other | aspartate animontransferase increased | Investigations | Group B (Control) | 1 | 24 | |
| other | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Group A (Active) | 2 | 54 | |
| other | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Group B (Control) | 3 | 24 | |
| other | pneumonia pseudomonal | Respiratory, thoracic and mediastinal disorders | Group A (Active) | 0 | 54 | |
| other | pneumonia pseudomonal | Respiratory, thoracic and mediastinal disorders | Group B (Control) | 2 | 24 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A (Active) | 7 | 54 |
| Total, all-cause mortality | Group B (Control) | 5 | 24 |
| Total, other adverse events | Group A (Active) | 39 | 54 |
| Total, other adverse events | Group B (Control) | 17 | 24 |
| Total, serious adverse events | Group A (Active) | 10 | 54 |
| Total, serious adverse events | Group B (Control) | 5 | 24 |
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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A (Active) vs Group B (Control): Number of Participants With SUSAR's (Suspected Unexpected Serious Adverse Reaction) | Trial comparisons |
| Group A (Active) vs Group B (Control): All Cause Mortality for the Entire Study Population | Trial comparisons |
| Group A (Active) vs Group B (Control): Number of Participants With Lung Fibrosis on Chest CT Scan at Follow up | Trial comparisons |
| Group A (Active) vs Group B (Control): All-cause Mortality Rate (Including Group That Entered During Ventilation) | Trial comparisons |
| Group A (Active) vs Group B (Control): All-cause Mortality Rate (Excluding Group That Entered During Ventilation) | Trial comparisons |
| Group A (Active) vs Group B (Control): Number of Participants With Nosocomial Bacterial or Invasive Fungal Infection for 28 Days (Phone Call) After Enrollment in Trial | Trial comparisons |
| Group A (Active) vs Group B (Control): Number of Participants With Serious Adverse Events | Trial comparisons |
| Group A (Active) vs Group B (Control): deaths from any cause | Trial comparisons |
| Group A (Active) vs Group B (Control): Number of Participants With SAR's (Serious Adverse Reaction) | Trial comparisons |
| Group A (Active) vs Group B (Control): Number of Participants With Adverse Events | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT04382755
GET https://conductscience.org/api/trials/v1/NCT04382755/registered?page=2