Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental COVID-19 drug fails to prevent respiratory failure in High-Risk patients

NCT ID NCT04393038

Disease control Sponsor: Abivax S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called ABX464 in 509 high-risk COVID-19 patients aged 65 and older, or those 18+ with risk factors like obesity or diabetes. The goal was to see if the drug could reduce inflammation and prevent the need for high-flow oxygen or a breathing machine. Unfortunately, the trial was stopped early because the drug did not show enough benefit compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABX464 (an experimental anti-inflammatory drug)
What this could lead to
If it had worked, this could have pointed toward a treatment to prevent severe breathing problems in older or high-risk COVID-19 patients.
What could go wrong
The trial was stopped early because it was not showing enough benefit. It was also a mid-stage study, so even positive results would have needed more testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

509 people

The number who actually took part.

Started

Jul 2020

Finished

Apr 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for COVID-19 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

COVID-19 acute respiratory failure prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Asklepios Klinik St. Georg

    Hamburg, 20099, Germany

  • Centre Hospitalier Départemental de Vendée

    La Roche-sur-Yon, 85000, France

  • Centre Hospitalier Universitaire de Nice

    Nice, 06003, France

  • Centre hospitalier Saint Pierre

    Brussels, 1000, Belgium

  • Centro Oncológico de Roraima - CECOR - NAP

    Boa Vista, Roraima, 69310-000, Brazil

  • Centro de Prevención y Rehabilitación de Enfermedades Pulmon

    Nuevo León, 64460, Mexico

  • Conjunto Hospitalar do Mandaqui

    São Paulo, 02401-400, Brazil

  • Consultorio médico

    Mérida, Yucatán, 97070, Mexico

  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases

    Milan, Lombardy, 20122, Italy

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

    Manaus, Amazonas, 69040-000, Brazil

  • H.G.U. Alicante

    Alicante, 03010, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario Infanta Leonor

    Madrid, 28031, Spain

  • Hospital das Clinicas da FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital de La Princesa

    Madrid, 28006, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hôpital Erasme

    Brussels, 1070, Belgium

  • Hôpital Nord

    Amiens, 80000, France

  • Hôpital Saint-Antoine

    Paris, 75571, France

  • Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro

    Rio de Janeiro, 21040-360, Brazil

  • Ospedale A. Manzonidi Lecco - ASST Lecco

    Lecco, 23900, Italy

  • Ospedale Luigi Sacco, AO-PU

    Milan, Lombardy, 20157, Italy

  • Ospedale Niguarda

    Milan, 20162, Italy

  • Ospedale San Paolo

    Milan, Lombardy, 20142, Italy

  • Ospedale di Vittorio Veneto - Medecina generale

    Vittorio Veneto, Treviso, 31029, Italy

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • UZ Gent

    Ghent, 9000, Belgium

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid

    Mannheim, Baden-Wurttemberg, 68167, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.