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TerminatedNCT04393038Mir-AgeUpdated Nov 26, 2025Results posted

ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19

A Phase 2/3 interventional study of ABX464 and Placebo in COVID-19, sponsored by Abivax S.A.. Terminated at 30 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Abivax S.A. · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Interim analysis concludes that the study is futile
Phase
Phase 2/3
Study type
Interventional
Enrollment
509
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing acute respiratory failure in patients aged ≥65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2 (the MiR-AGE study).

Read the detailed description

This phase 2/3 study will evaluate the efficacy and safety of ABX464 50mg QD (oral capsule), on treating inflammation and preventing acute respiratory failure in patients infected with SARS-CoV-2.

Eligible patients will be randomized according to a 2:1 ratio into 2 treatment cohorts as follows:

  • Standard of Care + Placebo cohort: 344 patients
  • Standard of Care + ABX464 50mg QD: 690 patients

Study design:

The study will consist of 2 periods:

  • Treatment phase: randomized patients will be treated for 28 days
  • Safety follow-up phase of 14 days after which the End of Study visit (EOS) will be performed.
02

Conditions studied

  • COVID-19

Browse trials for

Keywords

  • COVID-19
  • ABX464
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 509 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Abivax S.A. is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR, with at least one associated risk factor. Considered risk factors are:

    • Age ≥ 65 years
    • Obesity defined as BMI ≥ 30
    • Recent history of uncontrolled High Blood Pressure (SBP > 150 mm Hg DBP >100 mm Hg) according to investigator
    • Treated diabetes (type I or II)
    • History of ischemic cardiovascular disease
  2. Symptomatic patients at enrollment. Symptoms are defined as fever (body temperature ≥ 37.8 C oral/tympanic, or ≥ 38.2 C rectal) for more than 24 hours associated either with headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia or ageusia.
  3. Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.

  4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to Day 0:

    • Hemoglobin above 9.0 g / dL
    • Absolute Neutrophil Count ≥ 1000 / mm3
    • Platelets ≥ 100 000 mm3;
    • Creatinine clearance ≥ 50 mL / min by the Cockcroft Gault formula
    • Total serum bilirubin \< 2 x ULN
    • Alkaline phosphatase \< 2 x ULN, AST (SGOT) and ALT (SGPT) \< 3 x ULN;

Exclusion criteria

Exclusion Criteria:

  1. Patients with moderate or severe acute respiratory failure or requiring noninvasive ventilation or oxygen or with SpO2 \< 92% or tachypnea (respiratory rate ≥ 30 breaths/min).
  2. Patients treated with immunosuppressors and/or immunomodulators.
  3. Engrafted patients (organ and/or hematopoietic stem cells).
  4. Patients with uncontrolled auto-immune disease.
  5. Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
  6. Patients with preexisting, severe and not controlled organ failure.
  7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
  8. Pregnant or breast-feeding women.
  9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
  10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
  11. Hypersensitivity to ABX464 and/or its excipients.
  12. Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
509 participants (actual)

Study arms

  • Experimental
    ABX464

    ABX464 - Capsules + Standard of Care (SOC)

    Drug: ABX464

  • Placebo comparator
    Placebo

    Placebo - Capsules + Standard of Care (SOC)

    Drug: Placebo

Interventions

  • DrugABX464

    ABX464 50mg QD for 28 days + Standard of Care

  • DrugPlacebo

    Placebo 50mg QD for 28 days + Standard of Care

06

What researchers measure

Primary outcomes

  1. 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.

    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.

    Time frame: 28 days

Secondary outcomes

  1. Rate of Patients Hospitalized

    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.

    Time frame: 28 days

  2. Percentage of Patients Reporting Each Severity Rating on a 7-point Ordinal Scale

    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.

    Time frame: 28-day treatment period

  3. Change From Enrolment in Inflammatory Markers in Plasma and in Immune Phenotype and Assessment of Cell-activation Markers in PBMCs

    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.

    Time frame: at each study visit during the 28-day treatment period

  4. Rate of Patients Requiring Oxygen Supplementation

    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.

    Time frame: 28-day treatment period

  5. Time to Hospitalization

    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.

    Time frame: 28-day treatment period

  6. Time to Assisted Ventilation and Oxygen Supplementation

    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.

    Time frame: 28-day treatment period

  7. Change From Baseline in microRNA-124 Levels

    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.

    Time frame: at each study visit during the 28-day treatment period

  8. Change From Baseline in CRP, Troponin I & T and D-dimer

    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.

    Time frame: at each study visit during the 28-day treatment period

  9. SARS-CoV-2 Viral Load

    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.

    Time frame: at each study visit during the 28-day treatment period

  10. Number and Rates of Participants With Treatment Emergent Adverse Event

    Number and rates of participants included in the safety analysis set who had Treatment Emergent Adverse Event

    Time frame: From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period)

07

Results

Posted Nov 26, 2025

Participant flow

Participant flow — Overall Study
MilestoneABX464Placebo
Started339170
Completed18899
Not completed15171
Withdrew: Adverse event112
Withdrew: Protocol violation10
Withdrew: Death64
Withdrew: Withdrawal by subject248
Withdrew: Lost to follow-up54
Withdrew: Other reasons+ trial site terminated by sponsor + study terminated by sponsor9449
Withdrew: End of study date not collected in the ecrf104

Outcome measures

PrimaryRate 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.

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.

Time frame:
28 days
Reported as:
Count of participants · 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.
ParticipantsABX464Placebo
Responder16987
Non-responder247
Missing108
SecondaryRate of Patients Hospitalized

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.

Time frame:
28 days
Reported as:
Count of participants · Participants
Rate of Patients Hospitalized
ParticipantsABX464Placebo
Rate of Patients Hospitalized2311
SecondaryPercentage of Patients Reporting Each Severity Rating on a 7-point Ordinal Scale

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.

Time frame:
28-day treatment period

No measurements were reported for this outcome.

SecondaryChange From Enrolment in Inflammatory Markers in Plasma and in Immune Phenotype and Assessment of Cell-activation Markers in PBMCs

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.

Time frame:
at each study visit during the 28-day treatment period

No measurements were reported for this outcome.

SecondaryRate of Patients Requiring Oxygen Supplementation

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.

Time frame:
28-day treatment period

No measurements were reported for this outcome.

SecondaryTime to Hospitalization

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.

Time frame:
28-day treatment period

No measurements were reported for this outcome.

SecondaryTime to Assisted Ventilation and Oxygen Supplementation

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.

Time frame:
28-day treatment period

No measurements were reported for this outcome.

SecondaryChange From Baseline in microRNA-124 Levels

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.

Time frame:
at each study visit during the 28-day treatment period

No measurements were reported for this outcome.

SecondaryChange From Baseline in CRP, Troponin I & T and D-dimer

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.

Time frame:
at each study visit during the 28-day treatment period

No measurements were reported for this outcome.

SecondarySARS-CoV-2 Viral Load

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.

Time frame:
at each study visit during the 28-day treatment period

No measurements were reported for this outcome.

SecondaryNumber and Rates of Participants With Treatment Emergent Adverse Event

Number and rates of participants included in the safety analysis set who had Treatment Emergent Adverse Event

Time frame:
From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period)
Reported as:
Count of participants · Participants
Number and Rates of Participants With Treatment Emergent Adverse Event
ParticipantsABX464Placebo
Period 1: AE onset or worsens before or on Day 2820983
Period 2: AE onset or worsens after Day 282220

Adverse events

Collected over 49 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ABX4646/335 (1.8%)36/335 (10.7%)115/335 (34.3%)
Placebo4/170 (2.4%)20/170 (11.8%)27/170 (15.9%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventABX464Placebo
covid-19Infections and infestations10/3352/170
Covid-19 pneumoniaInfections and infestations5/3355/170
Respiratory FailureRespiratory, thoracic and mediastinal disorders1/3353/170
Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders3/3352/170
Oxygen saturation decreasedInvestigations1/3352/170
HypoxiaRespiratory, thoracic and mediastinal disorders2/3350/170
DyspnoeaRespiratory, thoracic and mediastinal disorders2/3350/170
Pancreatitis acuteGastrointestinal disorders2/3350/170
Abdominal pain upperGastrointestinal disorders2/3350/170
Diabetic metabolic decompensationMetabolism and nutrition disorders2/3350/170
Most frequent other events
Most frequent other events
EventABX464Placebo
HeadacheNervous system disorders49/33519/170
Abdominal pain upperGastrointestinal disorders32/3355/170
DiiarrhoeaGastrointestinal disorders30/3356/170
Back painMusculoskeletal and connective tissue disorders23/3354/170
NauseaGastrointestinal disorders20/3356/170

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ABX464PlaceboTotal
<=18 years101
Between 18 and 65 years240120360
>=65 years9850148
Age, Continuous
Age, Continuous(years)ABX464PlaceboTotal
Mean54.9 ± 15.3654.4 ± 15.0554.7 ± 15.24
Sex: Female, Male
Sex: Female, Male(Participants)ABX464PlaceboTotal
Female16084244
Male17986265
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ABX464PlaceboTotal
Hispanic or Latino274130404
Not Hispanic or Latino543589
Unknown or Not Reported11516
Region of Enrollment
Region of Enrollment(participants)ABX464PlaceboTotal
Belgium224
Brazil238114352
Italy201131
Mexico8715
United Kingdom101
Germany224
Spain241539
France201232
Peru24731
08

Study locations

30 sites
  • Centre hospitalier Saint Pierre
    Brussels, 1000, Belgium
  • Hôpital Erasme
    Brussels, 1070, Belgium
  • UZ Gent
    Ghent, 9000, Belgium
  • Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema
    Manaus, Amazonas 69040-000, Brazil
  • Centro Oncológico de Roraima - CECOR - NAP
    Boa Vista, Roraima 69310-000, Brazil
  • Hospital das Clinicas da FMUSP
    São Paulo, São Paulo 05403-000, Brazil
  • Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro
    Rio de Janeiro, 21040-360, Brazil
  • Conjunto Hospitalar do Mandaqui
    São Paulo, 02401-400, Brazil
  • Hôpital Nord
    Amiens, 80000, France
  • Centre Hospitalier Départemental de Vendée
    La Roche-sur-Yon, 85000, France
  • Centre Hospitalier Universitaire de Nice
    Nice, 06003, France
  • Hôpital Saint-Antoine
    Paris, 75571, France
  • Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid
    Mannheim, Baden-Wurttemberg 68167, Germany
  • Universitätsklinikum Bonn
    Bonn, North Rhine-Westphalia 53127, Germany
  • Asklepios Klinik St. Georg
    Hamburg, 20099, Germany
  • Asklepios Klinik Altona
    Hamburg, 22763, Germany
  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases
    Milan, Lombardy 20122, Italy
  • Ospedale San Paolo
    Milan, Lombardy 20142, Italy
  • Ospedale Luigi Sacco, AO-PU
    Milan, Lombardy 20157, Italy
  • Ospedale di Vittorio Veneto - Medecina generale
    Vittorio Veneto, Treviso 31029, Italy
  • Ospedale A. Manzonidi Lecco - ASST Lecco
    Lecco, 23900, Italy
  • Ospedale Niguarda
    Milan, 20162, Italy
  • Consultorio médico
    Mérida, Yucatán 97070, Mexico
  • Centro de Prevención y Rehabilitación de Enfermedades Pulmon
    Nuevo León, 64460, Mexico
  • Hospital Universitari Germans Trias i Pujol
    Badalona, Barcelona 08916, Spain
  • H.G.U. Alicante
    Alicante, 03010, Spain
  • Hospital del Mar
    Barcelona, 08003, Spain
  • Hospital de La Princesa
    Madrid, 28006, Spain
  • Hospital Universitario Infanta Leonor
    Madrid, 28031, Spain
  • Royal Free Hospital
    London, NW3 2QG, United Kingdom
09

References and documents

Study documents

  • Study protocol · Jan 26, 2021
  • Statistical analysis plan · Jun 16, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04393038
Lead sponsor
Abivax S.A.
Responsible party
Sponsor
First posted
May 19, 2020
Start date
Jul 1, 2020
Primary completion
Mar 5, 2021
Completion
Apr 16, 2021
Results posted
Nov 26, 2025
Last update
Nov 26, 2025

Study contacts

Eric CUA, MD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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