Trial Outcomes & Findings for ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 (NCT NCT04393038)
NCT ID: NCT04393038
Last Updated: 2025-11-26
Results Overview
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.
TERMINATED
PHASE2/PHASE3
509 participants
28 days
2025-11-26
Participant Flow
Participant milestones
| Measure |
ABX464
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
|---|---|---|
|
Overall Study
STARTED
|
339
|
170
|
|
Overall Study
COMPLETED
|
188
|
99
|
|
Overall Study
NOT COMPLETED
|
151
|
71
|
Reasons for withdrawal
| Measure |
ABX464
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Death
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
24
|
8
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Other reasons+ trial site terminated by sponsor + Study terminated by sponsor
|
94
|
49
|
|
Overall Study
End of Study date not collected in the eCRF
|
10
|
4
|
Baseline Characteristics
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
Baseline characteristics by cohort
| Measure |
ABX464
n=339 Participants
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
n=170 Participants
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
Total
n=509 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
240 Participants
n=492 Participants
|
120 Participants
n=492 Participants
|
360 Participants
n=984 Participants
|
|
Age, Categorical
>=65 years
|
98 Participants
n=492 Participants
|
50 Participants
n=492 Participants
|
148 Participants
n=984 Participants
|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 15.36 • n=492 Participants
|
54.4 years
STANDARD_DEVIATION 15.05 • n=492 Participants
|
54.7 years
STANDARD_DEVIATION 15.24 • n=984 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=492 Participants
|
84 Participants
n=492 Participants
|
244 Participants
n=984 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=492 Participants
|
86 Participants
n=492 Participants
|
265 Participants
n=984 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
274 Participants
n=492 Participants
|
130 Participants
n=492 Participants
|
404 Participants
n=984 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=492 Participants
|
35 Participants
n=492 Participants
|
89 Participants
n=984 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=492 Participants
|
5 Participants
n=492 Participants
|
16 Participants
n=984 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=492 Participants
|
2 participants
n=492 Participants
|
4 participants
n=984 Participants
|
|
Region of Enrollment
Brazil
|
238 participants
n=492 Participants
|
114 participants
n=492 Participants
|
352 participants
n=984 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=492 Participants
|
11 participants
n=492 Participants
|
31 participants
n=984 Participants
|
|
Region of Enrollment
Mexico
|
8 participants
n=492 Participants
|
7 participants
n=492 Participants
|
15 participants
n=984 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=492 Participants
|
0 participants
n=492 Participants
|
1 participants
n=984 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=492 Participants
|
2 participants
n=492 Participants
|
4 participants
n=984 Participants
|
|
Region of Enrollment
Spain
|
24 participants
n=492 Participants
|
15 participants
n=492 Participants
|
39 participants
n=984 Participants
|
|
Region of Enrollment
France
|
20 participants
n=492 Participants
|
12 participants
n=492 Participants
|
32 participants
n=984 Participants
|
|
Region of Enrollment
Peru
|
24 participants
n=492 Participants
|
7 participants
n=492 Participants
|
31 participants
n=984 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
ABX464
n=203 Participants
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
n=102 Participants
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
|---|---|---|
|
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.
Responder
|
169 Participants
|
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.
Non-responder
|
24 Participants
|
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.
Missing
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Number of patients randomized at time of Interim analysis
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.
Outcome measures
| Measure |
ABX464
n=203 Participants
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
n=102 Participants
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
|---|---|---|
|
Rate of Patients Hospitalized
|
23 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at each study visit during the 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at each study visit during the 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at each study visit during the 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at each study visit during the 28-day treatment periodPopulation: Analysis not done at time of interim analysis. After discontinuation of the study for futility, no further efficacy analysis were done
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period)Population: Analysis of safety was performed on the safety data set consisting in all patients who received at least one dose of ABX464 in the study. A total of 505 patients were included in the Safety Analysis Set.
Number and rates of participants included in the safety analysis set who had Treatment Emergent Adverse Event
Outcome measures
| Measure |
ABX464
n=335 Participants
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
n=170 Participants
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
|---|---|---|
|
Number and Rates of Participants With Treatment Emergent Adverse Event
Period 1: AE onset or worsens before or on Day 28
|
209 Participants
|
83 Participants
|
|
Number and Rates of Participants With Treatment Emergent Adverse Event
Period 2: AE onset or worsens after Day 28
|
22 Participants
|
20 Participants
|
Adverse Events
ABX464
Placebo
Serious adverse events
| Measure |
ABX464
n=335 participants at risk
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
n=170 participants at risk
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
|---|---|---|
|
Infections and infestations
covid-19
|
3.0%
10/335 • Number of events 10 • 49 days
|
1.2%
2/170 • Number of events 2 • 49 days
|
|
Infections and infestations
Covid-19 pneumonia
|
1.5%
5/335 • Number of events 5 • 49 days
|
2.9%
5/170 • Number of events 5 • 49 days
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.90%
3/335 • Number of events 3 • 49 days
|
1.2%
2/170 • Number of events 2 • 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
2/335 • Number of events 2 • 49 days
|
0.00%
0/170 • 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.30%
1/335 • Number of events 1 • 49 days
|
1.8%
3/170 • Number of events 3 • 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.60%
2/335 • Number of events 2 • 49 days
|
0.00%
0/170 • 49 days
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.60%
2/335 • Number of events 2 • 49 days
|
0.00%
0/170 • 49 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.60%
2/335 • Number of events 2 • 49 days
|
0.00%
0/170 • 49 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Gastrointestinal disorders
Upper gastrintestinal haemorrhage
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.60%
2/335 • Number of events 2 • 49 days
|
0.00%
0/170 • 49 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
General disorders
Chest pain
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Cardiac disorders
Non-cardiac chest pain
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Investigations
Oxygen saturation decreased
|
0.30%
1/335 • Number of events 1 • 49 days
|
1.2%
2/170 • Number of events 2 • 49 days
|
|
Hepatobiliary disorders
Hepatic artery embolism
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/335 • Number of events 1 • 49 days
|
0.00%
0/170 • 49 days
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Infections and infestations
Septic Shock
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
|
Vascular disorders
Shock
|
0.00%
0/335 • 49 days
|
0.59%
1/170 • Number of events 1 • 49 days
|
Other adverse events
| Measure |
ABX464
n=335 participants at risk
ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
|
Placebo
n=170 participants at risk
Placebo 50 mg once a day (oral capsule) + Standard of Care (SOC)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.0%
20/335 • Number of events 21 • 49 days
|
3.5%
6/170 • Number of events 7 • 49 days
|
|
Nervous system disorders
Headache
|
14.6%
49/335 • Number of events 51 • 49 days
|
11.2%
19/170 • Number of events 19 • 49 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
23/335 • Number of events 24 • 49 days
|
2.4%
4/170 • Number of events 4 • 49 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
32/335 • Number of events 34 • 49 days
|
2.9%
5/170 • Number of events 5 • 49 days
|
|
Gastrointestinal disorders
Diiarrhoea
|
9.0%
30/335 • Number of events 31 • 49 days
|
3.5%
6/170 • Number of events 6 • 49 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place