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

NCT04393038 | Terminated Phase 2 Results DMC

• 1 other identifier: ABX464-401
• Study Type: interventional
• Target: 509
• Locations: 8 countries
• Sites: 30

Brief 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).

Conditions

COVID-19

Keywords

COVID-19; ABX464

Outcome Measures

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.

  28 days

Secondary Outcomes (10)

• Rate of Patients Hospitalized

  28 days

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

  28-day treatment period

• 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

• Rate of Patients Requiring Oxygen Supplementation

  28-day treatment period

• Time to Hospitalization

  28-day treatment period

Study Arms (2)

ABX464

EXPERIMENTAL

ABX464 - Capsules + Standard of Care (SOC)

Drug: ABX464

Placebo

PLACEBO COMPARATOR

Placebo - Capsules + Standard of Care (SOC)

Drug: Placebo

Interventions

ABX464 DRUG

ABX464 50mg QD for 28 days + Standard of Care

ABX464

Placebo DRUG

Placebo 50mg QD for 28 days + Standard of Care

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (30)

Centre hospitalier Saint Pierre

Brussels, 1000, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema

Manaus, Amazonas, 69040-000, Brazil

Location

Centro Oncológico de Roraima - CECOR - NAP

Boa Vista, Roraima, 69310-000, Brazil

Location

Hospital das Clinicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro

Rio de Janeiro, 21040-360, Brazil

Location

Conjunto Hospitalar do Mandaqui

São Paulo, 02401-400, Brazil

Location

Hôpital Nord

Amiens, 80000, France

Location

Centre Hospitalier Départemental de Vendée

La Roche-sur-Yon, 85000, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06003, France

Location

Hôpital Saint-Antoine

Paris, 75571, France

Location

Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases

Milan, Lombardy, 20122, Italy

Location

Ospedale San Paolo

Milan, Lombardy, 20142, Italy

Location

Ospedale Luigi Sacco, AO-PU

Milan, Lombardy, 20157, Italy

Location

Ospedale di Vittorio Veneto - Medecina generale

Vittorio Veneto, Treviso, 31029, Italy

Location

Ospedale A. Manzonidi Lecco - ASST Lecco

Lecco, 23900, Italy

Location

Ospedale Niguarda

Milan, 20162, Italy

Location

Consultorio médico

Mérida, Yucatán, 97070, Mexico

Location

Centro de Prevención y Rehabilitación de Enfermedades Pulmon

Nuevo León, 64460, Mexico

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

H.G.U. Alicante

Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

ABX464

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: Abivax

info@abivax.com

+33 1 53 83 09 63

Study Officials

• Eric CUA, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded treatment bottles
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 2/3, randomized, double blind, placebo-controlled study

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 19, 2020
• Study Start: July 1, 2020
• Primary Completion: March 5, 2021
• Study Completion: April 16, 2021
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); FR (4); BR (5); BE (3); ME (2); IT (6); GB (1); ES (5)