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

NCT04393038 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2025-11-26

Study results available
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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

Interventions

DRUG

ABX464

ABX464 50mg QD for 28 days + Standard of Care

DRUG

Placebo

Placebo 50mg QD for 28 days + Standard of Care

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Principal Investigators

  • Eric CUA, MD · Centre Hospitalier Universitaire de Nice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-03-05
Completion
2021-04-16

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04393038 on ClinicalTrials.gov