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New drug fails to show benefit in severe COVID-19 pneumonia trial

NCT ID NCT05254990

Disease control Sponsor: Dompé Farmaceutici S.p.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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding reparixin to standard care could prevent death or the need for a breathing machine in 414 hospitalized adults with COVID-19 or other pneumonia. The trial was stopped early. Researchers compared reparixin to a placebo to see if it reduced severe outcomes like needing a ventilator or dying within 28 days.

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

414 people

The number who actually took part.

Started

Apr 2022

Finished

Sep 2024

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. Informed consent signed 2. Male and female ≥18 years old; 3. Patients hospitalized for clinically suspected CAP, defined as the occurrence of (within 48h from hospital admission): 1. at least 1 of the following signs/symptoms: dyspnea, cough, purulent sputum, crackles (rales) and/or rhonchi 2. body temperature \> 38°C or \<36°C (before or during admission) or leucocytosis (\> local ULN) 3. new/increased pulmonary infiltrate(s) by chest imaging 4. Need for non-invasive supplemental oxygen (NIAID-OS 5-6); 5. SpO2 \<92% at room air, or PaO2/FiO2 (or SpO2/FiO2) \<300; 6. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception: 1. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last IMP dose 2. A non-hormonal intrauterine device \[IUD\] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last IMP dose 3. A male sexual partner who agrees to use a male condom with spermicide 4. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake. Exclusion Criteria: 1. Treatment with IMV or ECMO (NIAID-OS 7); 2. Hepatic dysfunction: ALT or AST \> 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score B or C); 3. Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) \<50 mL/min/1.73 m2, or need for haemodialysis or hemofiltration; 4. Current use of \>2 immunosuppressive medications or immunosuppression status (AIDS, aplastic anaemia, asplenia, systemic chemotherapy within the past 3 months, neutropenia (ANC \< local LLN), solid organ or bone marrow transplant recipients) 5. Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period; 6. Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening 7. History of: 1. intolerance or hypersensitivity to ibuprofen to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole does not qualify for exclusion) 2. lactase deficiency, galactosemia or glucose-galactose malabsorption 3. gastrointestinal bleeding or perforation due to previous NSAIDs therapy or recurrent peptic ulcer/haemorrhage 4. allergy to reparixin or any component of the IMP formulation 8. Active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage 9. Participation in other interventional clinical trials 10. Clinical condition not compatible with oral administration of the study drug 11. Pregnancy: 1. positive or missing pregnancy test before first drug intake or day 1; 2. pregnant or lactating women; 3. women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study 12. Current hospital stay \>72h 13. Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

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Conditions

The condition(s) this trial relates to.

COVID-19 pneumonia

As listed by the trial registrant

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

Infectious pneumonia Severe COVID-19

Contacts and locations

Locations

  • AOUP "P.Giaccone" - UOC Pneumologia

    Palermo, 90127, Italy

  • ASST - Ospedale Papa Giovanni XXIII - UOC Pneumologia

    Bergamo, 24127, Italy

  • ASST Grande Ospedale Metropolitano Niguarda Dipartimento Malattie Infettive

    Milan, 20162, Italy

  • ASST SANTI PAOLO E CARLO Ospedale San Paolo Struttura Complessa Malattie Infettive

    Milan, 20142, Italy

  • ASST-Monza Ospedale San Gerardo Malattie Infettive

    Monza, 20900, Italy

  • Acibadem Atakent Hospital

    Istanbul, 34303, Turkey (Türkiye)

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Augusta University Health - Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Universitaria di Bologna - Ospedale Sant'Orsola

    Bologna, 40138, Italy

  • Baptist Hospitals of Southeast Texas

    Beaumont, Texas, 77701, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Campus Universitario "Salvatore Venuta", Complesso Clinico, Padiglione B, 8° livello, Pneumologia

    Catanzaro, 88100, Italy

  • Clinica Adventista Belgrano

    Buenos Aires, 1430, Argentina

  • Clinica Independencia

    Munro, Buenos Aires, 1605, Argentina

  • Clinica Pneumologica "L. Vanvitelli" - Osp Monaldi

    Naples, 80131, Italy

  • Denver Health

    Denver, Colorado, 80204, United States

  • Dicle University, Medical Faculty

    Diyarbakır, 21280, Turkey (Türkiye)

  • Dokuz Eylul University Faculty of Medicine

    Izmir, 35340, Turkey (Türkiye)

  • Duke University Hospital

    Durham, North Carolina, 27708, United States

  • Emory Johns Creek Hospital

    Atlanta, Georgia, 30342, United States

  • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia, Dipartimento di Scienze Mediche e Malattie Infettive

    Pavia, 27100, Italy

  • Gaziantep Universitesi Sahinbey Arastirma Ve Uygulama Hastanesi

    Gaziantep, 27310, Turkey (Türkiye)

  • Helios Hamper-Klinikum Dachau

    Dachau, Bavaria, 85221, Germany

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, 1280, Argentina

  • Hospital Interzonal General de Agudos Dr Jose Penna

    Bahía Blanca, Buenos Aires, 8001, Argentina

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1181, Argentina

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, 1900, Argentina

  • IRCCS Istituto Clinico Humanitas U.O. Medicina D'Urgenza

    Milan, 20089, Italy

  • IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione

    Milan, 20132, Italy

  • Inonu Uni.Med.Faculty

    Malatya, 44100, Turkey (Türkiye)

  • Instituto Medico Platense

    La Plata, Buenos Aires, 1900, Argentina

  • Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • KH der Barmherzigen Brüder Linz

    Linz, 4020, Austria

  • Kayseri State Hospital

    Kayseri, 38039, Turkey (Türkiye)

  • Kepler Universitatsklinikum Med Campus III

    Linz, 4020, Austria

  • Klinik Favoriten (Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital mit Gottfried von Preyer'schem Kinderspital)

    Vienna, 1100, Austria

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380, Turkey (Türkiye)

  • MD Banner University Medical Center /Arizona University

    Tucson, Arizona, 85719, United States

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101, Australia

  • MedStar Health Research Institute-Hyatteville, Maryland

    Washington D.C., District of Columbia, 20010, United States

  • Medizinische Universitaet Wien, Medizinische Klinik I, Abteilung für Infektionskrankheiten und Tropenmedizin

    Vienna, 1090, Austria

  • Mercy Research St Louis

    St Louis, Missouri, 63141, United States

  • Methodist Hospital

    Gary, Indiana, 46404, United States

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670, United States

  • NYU Langone Hospital-Brooklyn

    Brooklyn, New York, 11220, United States

  • New York University Langone Health

    New York, New York, 10016, United States

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462, United States

  • Northwestern University, Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Nuevo Hospital San Roque

    Córdoba, 5000, Argentina

  • Oregon Health & Science University (OHSU) - Pulmonary Clinic

    Portland, Oregon, 97239, United States

  • Research Alliance Inc.

    Clearwater, Florida, 33756, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Sanatorio Agote

    Buenos Aires, C1425 EOE, Argentina

  • Sanatorio Britanico S.A.

    Rosario, Santa Fe Province, 2000, Argentina

  • Sanatorio Finochietto

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1187, Argentina

  • Sanatorio Privado Duarte Quiroz De Clinica Colombo SA

    Córdoba, 5000, Argentina

  • Sanatorio Privado de la Cañada - Cordoba

    Córdoba, 5000, Argentina

  • Sanatorio de la Cañada

    Villa María, Córdoba Province, 5900, Argentina

  • Struttura semplice di terapia demi-intensiva respiratoria S.C. di pneumologia AO IRCCS Santa Maria Nuova

    Reggio Emilia, 42123, Italy

  • Texoma Medical Center

    Denison, Texas, 75020, United States

  • UCI Health

    Orange, California, 92868, United States

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony, 01307, Germany

  • University Hospital - MU Healthcare

    Columbia, Missouri, 65212, United States

  • University Of Genoa - Ospedale Policlinico IRCCS San Martino di Genova

    Genova, 16132, Italy

  • University of Florida-Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Utah Hospitals & Clinics

    Salt Lake City, Utah, 84108, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903, United States

  • Università degli Studi di Milano-Ospedale "L.Sacco" Polo Universitario - ASST Fatebenefratelli Sacco

    Milan, 20157, Italy

  • Universitätsmedizin Göttingen

    Göttingen, Südniedersachsen, 37075, Germany

  • Virginia Commonwealth University Health

    Richmond, Virginia, 23298, United States

  • Washington University, School of Medicine

    St Louis, Missouri, 63110, United States

  • Westmead Hospital

    Sydney, New South Wales, 2145, Australia

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

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