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

NCT ID: NCT04393038

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 509 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-04-16

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ABX464

ABX464 - Capsules + Standard of Care (SOC)

Group Type: EXPERIMENTAL

ABX464

Intervention Type: DRUG

ABX464 50mg QD for 28 days + Standard of Care

Placebo

Placebo - Capsules + Standard of Care (SOC)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 50mg QD for 28 days + Standard of Care

Interventions

ABX464

ABX464 50mg QD for 28 days + Standard of Care

Intervention Type: DRUG

Placebo

Placebo 50mg QD for 28 days + Standard of Care

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric CUA, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

Centre hospitalier Saint Pierre

Brussels, , Belgium

Hôpital Erasme

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

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

Manaus, Amazonas, Brazil

Centro Oncológico de Roraima - CECOR - NAP

Boa Vista, Roraima, Brazil

Hospital das Clinicas da FMUSP

São Paulo, São Paulo, Brazil

Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro

Rio de Janeiro, , Brazil

Conjunto Hospitalar do Mandaqui

São Paulo, , Brazil

Hôpital Nord

Amiens, , France

Centre Hospitalier Départemental de Vendée

La Roche-sur-Yon, , France

Centre Hospitalier Universitaire de Nice

Nice, , France

Hôpital Saint-Antoine

Paris, , France

Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid

Mannheim, Baden-Wurttemberg, Germany

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Asklepios Klinik St. Georg

Hamburg, , Germany

Asklepios Klinik Altona

Hamburg, , Germany

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases

Milan, Lombardy, Italy

Ospedale San Paolo

Milan, Lombardy, Italy

Ospedale Luigi Sacco, AO-PU

Milan, Lombardy, Italy

Ospedale di Vittorio Veneto - Medecina generale

Vittorio Veneto, Treviso, Italy

Ospedale A. Manzonidi Lecco - ASST Lecco

Lecco, , Italy

Ospedale Niguarda

Milan, , Italy

Consultorio médico

Mérida, Yucatán, Mexico

Centro de Prevención y Rehabilitación de Enfermedades Pulmon

Nuevo León, , Mexico

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

H.G.U. Alicante

Alicante, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital de La Princesa

Madrid, , Spain

Hospital Universitario Infanta Leonor

Madrid, , Spain

Royal Free Hospital

London, , United Kingdom

Countries

Belgium; Brazil; France; Germany; Italy; Mexico; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABX464-401

Identifier Type: -

Identifier Source: org_study_id