Trial · NCT04393038
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Secondary | Number and Rates of Participants With Treatment Emergent Adverse Event | From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period) | Number and rates of participants included in the safety analysis set who had Treatment Emergent Adverse Event |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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