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

Major trial tests new antibody drug for hospitalized COVID-19 patients

NCT ID NCT04315948

Disease control Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Updated 2 times

Summary

This large, completed trial tested several potential COVID-19 treatments in over 1,500 hospitalized adults across Europe. Earlier drugs like remdesivir and hydroxychloroquine were dropped after showing no benefit. The current phase is testing a new antibody combination called AZD7442 against a placebo, alongside standard care. The goal is to see if it improves patient recovery and reduces the need for oxygen or ventilation.

What this could mean

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

Active substance
Remdesivir, lopinavir/ritonavir, hydroxychloroquine, interferon beta-1a, and AZD7442 (a monoclonal antibody combination)
What this could lead to
If successful, AZD7442 could become a standard treatment to help hospitalized COVID-19 patients recover faster and reduce severe outcomes.
What could go wrong
This is an early-stage analysis for AZD7442 within a larger trial; previous drugs tested were stopped due to lack of benefit. Results may not apply to all patients or variants.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,552 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2023

Lead sponsor

A government agency

The lead sponsor is a government body.

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 of age at the time of enrolment 2. Hospitalized patients with any of the following criteria: 1. the presence of pulmonary rales/crackles on clinical exam OR 2. SpO2 ≤ 94% on room air OR 3. requirement of supplementary oxygen including high flow oxygen devices or non-invasive ventilation 3. A time between onset of symptoms and randomization of less than 11 days 4. A positive SARS-CoV-2 PCR performed on a NP swab within the 5 days preceding randomization 5. The result of a rapid antigen test performed on a NP swab within the 6 hours preceding randomization 6. Contraceptive use by men or women. 1. Male participants: Contraception for male participants is required; to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue for 90 days following administration of IMP. 2. Female participants: Women of child-bearing potential must agree to use contraception for 365 days following administration of IMP Exclusion Criteria: 1. Refusal to participate expressed by patient or legally authorized representative 2. Need for invasive mechanical ventilation and/or ECMO at the time of enrolment 3. Spontaneous blood ALT/AST levels \> 5 times the upper limit of normal 4. Glomerular filtration rate (GFR) \< 15 mL/min or requiring maintenance dialysis 5. Pregnancy or breast-feeding 6. Anticipated transfer to another hospital, which is not a study site within 72 hours following randomization 7. Known history of allergy or reaction to any component of the study drug formulation. 8. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal or polyclonal antibodies. 9. Any prior receipt of investigational or licensed other mAb/biologic indicated for the prevention of SARS-CoV-2 infection or COVID-19, and for those not vaccinated, expected receipt of vaccine in the 30 days following hospital discharge, according to current recommendation in each country. 10. Any medical condition which, in the judgment of the investigator, could interfere with the interpretation of the trial results or that preludes to protocol adherence.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Corona virus infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 Orthocoronavirinae infectious disease pneumonia

As listed by the trial registrant

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

Corona virus infection

Contacts and locations

Locations

  • AP-HP Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • APHP - Hôpital Bichat Claude Bernard

    Paris, 75018, France

  • APHP - Hôpital Cochin

    Paris, 75014, France

  • APHP - Hôpital Lariboisière

    Paris, 75010, France

  • APHP - Hôpital Necker

    Paris, 75015, France

  • APHP - Hôpital Saint Antoine

    Paris, 75012, France

  • APHP - Hôpital Saint Louis

    Paris, 75010, France

  • APHP - Hôpital Tenon

    Paris, 75020, France

  • APHP - Hôpital Universitaire Pitié Salpêtrière

    Paris, 75013, France

  • APHP - hôpital Henri-Mondor

    Créteil, 94010, France

  • APHP- Hôpital Européen Georges-Pompidou

    Paris, 75015, France

  • Akershus Unniversity Hospital

    Oslo, Norway

  • CH Bretagne Atlantique

    Vannes, 56000, France

  • CH Bretagne Atlantique

    Vannes, France

  • CH Cornouaille

    Quimper, France

  • CHU APHP Ambroise-Paré

    Boulogne-Billancourt, France

  • CHU Nîmes

    Nîmes, France

  • CHU Poitiers

    Poitiers, France

  • CHU de Reims

    Reims, 51100, France

  • CHULN- Hospital de Santa Maria

    Lisbon, Portugal

  • Centre Hospitalier Andrée Rosemon

    Cayenne, 97306, France

  • Centre Hospitalier Annecy Genevois

    Épagny, 74370, France

  • Centre Hospitalier Luxembourg

    Luxembourg, L-1210, Luxembourg

  • Centre Hospitalier Regional Metz-Thionville

    Ars-Laquenexy, 57085, France

  • Centre Hospitalier Régional Universitaire de Besançon

    Besançon, 25000, France

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 59000, France

  • Centre Hospitalier Régional Universitaire de Strasbourg

    Strasbourg, 67000, France

  • Centre Hospitalier Régional et Universitaire de Nancy

    Nancy, 54000, France

  • Centre Hospitalier Universitaire Amiens-Picardie

    Amiens, 80054, France

  • Centre Hospitalier Universitaire Dijon-Bourgogne

    Dijon, 21000, France

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000, France

  • Centre Hospitalier Universitaire de Martinique

    Fort de France, 97261, France

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, 34000, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44000, France

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033, France

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Etienne, 42055, France

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31000, France

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31300, France

  • Centre Hospitalier Universitaire de Tours

    Tours, 37000, France

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208, France

  • Centre Hospitalo-Universitaire de Grenoble

    La Tronche, 38700, France

  • Centre Hospitalo-Universitaire de Nice

    Nice, 06000, France

  • Centro Hospitalar Universitário de São João, EPE

    Porto, Portugal

  • Evaggelismos General Hospital

    Athens, Greece

  • General University Hospital of Patras

    Pátrai, Greece

  • Groupe Hospitalier de la Région de Mulhouse Sud Alsace

    Mulhouse, 68100, France

  • Hopital DELAFONTAINE

    Saint-Denis, 93200, France

  • Hospices Civil

    Colmar, France

  • Hospices Civils de Lyon

    Lyon, 69000, France

  • Hospital de Cascais

    Cascais, Portugal

  • Hôpital Erasme - Cliniques universitaires de Bruxelles

    Brussels, 1070, Belgium

  • Hôpital La Citadelle

    Liège, 4000, Belgium

  • Hôpital Paris Saint-Joseph et Marie Lannelongue

    Paris, 75014, France

  • Hôpital Saint Luc

    Brussels, 1200, Belgium

  • Hôpital d'Instruction des Armées BEGIN

    Saint-Mandé, 94160, France

  • Hôpitaux Robert Schuman

    Luxembourg, L-2450, Luxembourg

  • Kepler Universitätsklinikum Linz

    Linz, Austria

  • Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität

    Salzburg, 5020, Austria

  • Lovisenberg Diaconal Hospital

    Oslo, Norway

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Oslo University Hospital

    Oslo, Norway

  • Pôle Hospitalier Jolimont / site de Mons-Warquignies

    Mons, Belgium

More trials for these conditions

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