ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19 (Mir-Age)

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).

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: ABX464; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Hôpital Erasme
  • Brussels, Belgium, 1000
    • Centre hospitalier Saint Pierre
  • Ghent, Belgium, 9000
    • UZ Gent
• Brazil
  • Rio de Janeiro, Brazil, 21040-360
    • Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro
  • São Paulo, Brazil, 02401-400
    • Conjunto Hospitalar do Mandaqui
  • Amazonas
    • Manaus, Amazonas, Brazil, 69040-000
      • Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema
  • Roraima
    • Boa Vista, Roraima, Brazil, 69310-000
      • Centro Oncológico de Roraima - CECOR - NAP
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-000
      • Hospital das Clínicas da FMUSP
• France
  • Amiens, France, 80000
    • Hôpital Nord
  • La Roche-sur-Yon, France, 85000
    • Centre Hospitalier Départemental de Vendée
  • Nice, France, 06003
    • Centre Hospitalier Universitaire de Nice
  • Paris, France, 75571
    • Hôpital Saint-Antoine
• Germany
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Universitätsklinikum Bonn
• Italy
  • Lecco, Italy, 23900
    • Ospedale A. Manzonidi Lecco - ASST Lecco
  • Milan, Italy, 20162
    • Ospedale Niguarda
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases
    • Milan, Lombardy, Italy, 20142
      • Ospedale San Paolo
    • Milan, Lombardy, Italy, 20157
      • Ospedale Luigi Sacco, AO-PU
  • Treviso
    • Vittorio Veneto, Treviso, Italy, 31029
      • Ospedale di Vittorio Veneto - Medecina generale
• Mexico
  • Nuevo León, Mexico, 64460
    • Centro de Prevención y Rehabilitación de Enfermedades Pulmon
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Consultorio Medico
• Spain
  • Alicante, Spain, 03010
    • H.G.U. Alicante
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Madrid, Spain, 28006
    • Hospital de La Princesa
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
• United Kingdom
  • London, United Kingdom, Nw3 2QG
    • Royal Free Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABX464; ABX464 - Capsules + Standard of Care (SOC)	Drug: ABX464; ABX464 50mg QD for 28 days + Standard of Care
Placebo Comparator: Placebo; Placebo - Capsules + Standard of Care (SOC)	Drug: Placebo; Placebo 50mg QD for 28 days + Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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	From D0 to D48 (28 days treatment period + up to 20 days Safety follow-up period)

Collaborators and Investigators

• Sponsor: Abivax S.A.
• Investigators: Principal Investigator: Eric CUA, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; ABX464
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; ABX464
• Other Study ID Numbers: ABX464-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No