Trial · NCT04393038
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
NCT04393038, Phase 2, Phase 3, Terminated, Abivax S.A.; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19. Trials, record NCT04393038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04393038
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
- NCT number
- NCT04393038
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 509 participants, actual
- Lead sponsor
- Abivax S.A.
- Conditions
- COVID-19
- Interventions
- ABX464, Placebo
- First posted
- 2020-05-19
- Last updated
- 2025-11-26
- Results first posted
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | 28 days | Subjects will be assessed as responders if they did not receive oxygen supplementation through IMV and NIV during the treatment period, and they are alive at the end of the 28-days treatment period. Non responders are subjects who receive oxygen supplementation (through IMV and NIV during the treatment period) and/or who die during the 28-days treatment period. The use of high-flow oxygen being defined as settings of 3 L/min or greater AND with at least one SpO2 measurement \< 92%, with or without O2 supplementation). Descriptive statistics will be presented by treatment arm. |
| Secondary | Rate of Patients Hospitalized | 28 days | To evaluate the proportion of patients requiring hospitalization during the study compared to the {Standard of Care + placebo} group An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Efficacy results are only available for the 305 patients randomized at the time of the interim analysis. |
| Secondary | Percentage of Patients Reporting Each Severity Rating on a 7-point Ordinal Scale | 28-day treatment period | 7-point ordinal scale is defined as Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
| Secondary | Change From Enrolment in Inflammatory Markers in Plasma and in Immune Phenotype and Assessment of Cell-activation Markers in PBMCs | at each study visit during the 28-day treatment period | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
| Secondary | Rate of Patients Requiring Oxygen Supplementation | 28-day treatment period | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
| Secondary | Time to Hospitalization | 28-day treatment period | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
| Secondary | Time to Assisted Ventilation and Oxygen Supplementation | 28-day treatment period | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
| Secondary | Change From Baseline in microRNA-124 Levels | at each study visit during the 28-day treatment period | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
| Secondary | Change From Baseline in CRP, Troponin I & T and D-dimer | at each study visit during the 28-day treatment period | An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
| Secondary | SARS-CoV-2 Viral Load | at each study visit during the 28-day treatment period | Nasopharyngeal sample and/or in blood An interim analysis was triggered when the first 305 patients were randomized in the study. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Only key outcome analysis was performed during this interim analysis. After discontinuation of the study for futility, Abivax decided to not perform the analysis on this secondary outcome (SAP was amended accordingly). Therefore, these data are not available. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | 28 days | An interim analysis was triggered when the first 305 patients were randomized in the study. Randomization was not discontinued during the interim analysis. As the study was stopped for futility based on the interim analysis results, no efficacy data were collected for the patients who were randomized but not included in the interim analysis. Efficacy results are only available for the 305 patients randomized at the time of the interim analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Patients Hospitalized | 28 days | Number of patients randomized at time of Interim analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Reporting Each Severity Rating on a 7-point Ordinal Scale | 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | ||
| SECONDARY | Change From Enrolment in Inflammatory Markers in Plasma and in Immune Phenotype and Assessment of Cell-activation Markers in PBMCs | at each study visit during the 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | ||
| SECONDARY | Rate of Patients Requiring Oxygen Supplementation | 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | ||
| SECONDARY | Time to Hospitalization | 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | ||
| SECONDARY | Time to Assisted Ventilation and Oxygen Supplementation | 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | ||
| SECONDARY | Change From Baseline in microRNA-124 Levels | at each study visit during the 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | ||
| SECONDARY | Change From Baseline in CRP, Troponin I & T and D-dimer | at each study visit during the 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done | ||
| SECONDARY | SARS-CoV-2 Viral Load | at each study visit during the 28-day treatment period | Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | ABX464 | Responder | 169 | Participants | |
Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | Placebo | Responder | 87 | Participants | |
Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | ABX464 | Non-responder | 24 | Participants | |
Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | Placebo | Non-responder | 7 | Participants | |
Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | ABX464 | Missing | 10 | Participants | |
Rate of Responders: i.e. Rate of Patients Who do Not Require Use of High-flow Oxygen Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively) Within 28 Days and Who Are Alive at the End of the 28 Days Period. | Placebo | Missing | 8 | Participants | |
| Rate of Patients Hospitalized | ABX464 | 23 | Participants | ||
| Rate of Patients Hospitalized | Placebo | 11 | Participants | ||
| Number and Rates of Participants With Treatment Emergent Adverse Event | ABX464 | Period 1: AE onset or worsens before or on Day 28 | 209 | Participants | |
| Number and Rates of Participants With Treatment Emergent Adverse Event | Placebo | Period 1: AE onset or worsens before or on Day 28 | 83 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABX464 | 339 | |
| Overall Study | STARTED | Placebo | 170 | |
| Overall Study | COMPLETED | ABX464 | 188 | |
| Overall Study | COMPLETED | Placebo | 99 | |
| Overall Study | NOT COMPLETED | ABX464 | 151 | |
| Overall Study | NOT COMPLETED | Placebo | 71 |
Source ClinicalTrials.gov
Adverse events66
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 | Abdominal pain upper | Gastrointestinal disorders | ABX464 | 32 | 335 | 34 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 5 | 170 | 5 |
| other | Diiarrhoea | Gastrointestinal disorders | ABX464 | 30 | 335 | 31 |
| other | Diiarrhoea | Gastrointestinal disorders | Placebo | 6 | 170 | 6 |
| other | Nausea | Gastrointestinal disorders | ABX464 | 20 | 335 | 21 |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 170 | 7 |
| other | Headache | Nervous system disorders | ABX464 | 49 | 335 | 51 |
| other | Headache | Nervous system disorders | Placebo | 19 | 170 | 19 |
| other | Back pain | Musculoskeletal and connective tissue disorders | ABX464 | 23 | 335 | 24 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 4 | 170 | 4 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABX464 | 6 | 335 |
| Total, all-cause mortality | Placebo | 4 | 170 |
| Total, other adverse events | ABX464 | 115 | 335 |
| Total, other adverse events | Placebo | 27 | 170 |
| Total, serious adverse events | ABX464 | 36 | 335 |
| Total, serious adverse events | Placebo | 20 | 170 |
Source ClinicalTrials.gov
Papers0
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ABX464 vs Placebo: Rate of Patients Hospitalized | Trial comparisons |
| ABX464 vs Placebo: deaths from any cause | Trial comparisons |
| ABX464 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/NCT04393038
GET https://conductscience.org/api/trials/v1/NCT04393038/events?page=2