COVID-19Phase 2/3Mir-AgeNCT04393038
ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19
A Phase 2/3 study testing ABX464 in people with COVID-19, run by Abivax S.A. at 30 sites in 8 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- ABX464
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 509 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 1 Jul 2020to 16 Apr 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
- 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;
Who cannot join
- 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).
- Patients treated with immunosuppressors and/or immunomodulators.
- Engrafted patients (organ and/or hematopoietic stem cells).
- Patients with uncontrolled auto-immune disease.
- Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
- Patients with preexisting, severe and not controlled organ failure.
Show all 12Show fewer
- History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
- Pregnant or breast-feeding women.
- Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
- Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
- Hypersensitivity to ABX464 and/or its excipients.
- Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
Italy6 sites
Ospedale A. Manzonidi Lecco - ASST Lecco
Lecco, 23900
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases
Milan, Lombardy, 20122
Ospedale San Paolo
Milan, Lombardy, 20142
Ospedale Luigi Sacco, AO-PU
Milan, Lombardy, 20157
Ospedale Niguarda
Milan, 20162
Ospedale di Vittorio Veneto - Medecina generale
Vittorio Veneto, Treviso, 31029
Brazil5 sites
Centro Oncológico de Roraima - CECOR - NAP
Boa Vista, Roraima, 69310-000
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema
Manaus, Amazonas, 69040-000
Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro
Rio de Janeiro, 21040-360
Hospital das Clinicas da FMUSP
São Paulo, São Paulo, 05403-000
Conjunto Hospitalar do Mandaqui
São Paulo, 02401-400
Spain5 sites
H.G.U. Alicante
Alicante, 03010
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital de La Princesa
Madrid, 28006
Hospital Universitario Infanta Leonor
Madrid, 28031
France4 sites
Hôpital Nord
Amiens, 80000
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon, 85000
Centre Hospitalier Universitaire de Nice
Nice, 06003
Hôpital Saint-Antoine
Paris, 75571
Germany4 sites
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Asklepios Klinik St. Georg
Hamburg, 20099
Asklepios Klinik Altona
Hamburg, 22763
Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid
Mannheim, Baden-Wurttemberg, 68167
Belgium3 sites
Centre hospitalier Saint Pierre
Brussels, 1000
Hôpital Erasme
Brussels, 1070
UZ Gent
Ghent, 9000
Mexico2 sites
Consultorio médico
Mérida, Yucatán, 97070
Centro de Prevención y Rehabilitación de Enfermedades Pulmon
Nuevo León, 64460
About this study
Official title: A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated 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.
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.
- Conditions
- COVID-19
- Being tested
- ABX464, Placebo
- Keywords
- COVID-19, ABX464
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464Drug
ABX464 50mg QD for 28 days + Standard of Care
PlaceboDrug
Placebo 50mg QD for 28 days + Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| ABX464 | Experimental | ABX464 - Capsules + Standard of Care (SOC) Receives: Drug: ABX464 |
| Placebo | Placebo comparator | Placebo - Capsules + Standard of Care (SOC) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (10)
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.
Measured: 28 days
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.
Measured: 28-day treatment period
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.
Measured: at each study visit during the 28-day treatment period
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.
Measured: 28-day treatment period
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.
Measured: 28-day treatment period
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.
Measured: 28-day treatment period
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.
Measured: at each study visit during the 28-day treatment period
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.
Measured: at each study visit during the 28-day treatment period
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.
Measured: at each study visit during the 28-day treatment period
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
Measured: From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Jul 2020
- Primary completion5 Mar 2021
- Study completion16 Apr 2021
Why it stopped: Interim analysis concludes that the study is futile
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2/3, randomized, double blind, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric CUA, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393038
- Sponsor's protocol ID
- ABX464-401
- Acronym
- Mir-Age
- Status last verified
- Nov 2025
- First submitted
- 18 May 2020
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated 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.
- ClinicalTrials.gov ID
- NCT04393038
- Acronym / sponsor ID
- Mir-Age / ABX464-401
- Conditions
- COVID-19
- Keywords
- COVID-19, ABX464
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis concludes that the study is futile
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase 2/3, randomized, double blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| ABX464 | Experimental | Drug: ABX464ABX464 - Capsules + Standard of Care (SOC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - Capsules + Standard of Care (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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.
- Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
- Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to Day 0:
Key exclusion criteria (12 listed)
- 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).
- Patients treated with immunosuppressors and/or immunomodulators.
- Engrafted patients (organ and/or hematopoietic stem cells).
- Patients with uncontrolled auto-immune disease.
- Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX464ABX464 50mg QD for 28 days + Standard of Care | Drug | ABX464 |
| PlaceboPlacebo 50mg QD for 28 days + Standard of Care | Drug | Placebo |
Primary outcome
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.
Time frame: 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.
10 secondary outcomes
Rate of Patients Hospitalized
Time frame: 28 days
Percentage of Patients Reporting Each Severity Rating on a 7-point Ordinal Scale
Time frame: 28-day treatment period
Change From Enrolment in Inflammatory Markers in Plasma and in Immune Phenotype and Assessment of Cell-activation Markers in PBMCs
Time frame: at each study visit during the 28-day treatment period
Rate of Patients Requiring Oxygen Supplementation
Time frame: 28-day treatment period
Time to Hospitalization
Time frame: 28-day treatment period
Time to Assisted Ventilation and Oxygen Supplementation
Time frame: 28-day treatment period
Change From Baseline in microRNA-124 Levels
Time frame: at each study visit during the 28-day treatment period
Change From Baseline in CRP, Troponin I & T and D-dimer
Time frame: at each study visit during the 28-day treatment period
SARS-CoV-2 Viral Load
Time frame: at each study visit during the 28-day treatment period
Number and Rates of Participants With Treatment Emergent Adverse Event
Time frame: From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric CUA, MD principal investigator
Centre Hospitalier Universitaire de Nice
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ABX464 in people with COVID-19, run by Abivax S.A. at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy, Brazil, Spain, France, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.