Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia
NCT ID: NCT05254990
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
409 participants
INTERVENTIONAL
2022-04-27
2024-09-27
Brief Summary
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\- To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19.
Secondary objectives:
\- To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality.
Safety objectives:
\- To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.
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Detailed Description
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It will enrol 526 male and female patients \>18 years, hospitalised for CAP (including COVID-19), assigned (1:1) to receive either oral reparixin (treatment group) or matched placebo (control group) three times a day (TID) for up to 21 days. Randomisation will be stratified according to disease severity and site.
All the patients will receive the standard of care based on their clinical need, including COVID-19 and CAP medications, as per local standard therapy at the trial site and in line with international guidelines.
The primary outcome will be evaluated at day 28, secondary will be evaluated from day 3 to day 180.
An independent external data monitoring committee (DMC) will oversee the study and evaluate unblinded interim data for efficacy, futility, and safety.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Reparixin + standard of care
Reparixin will be administered orally at the dose of 1200 mg (2 x 600 mg tablets) TID (6 tablets daily) for up to 21 days.
The three daily doses will be administered maintaining an interval between doses of about 8 hours.
Reparixin
Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP can be taken with a glass of water (about 250 mL) and a light meal or snack, as it is preferable that reparixin is taken with food. However, if the patient is unable to eat, the study drug may still be administered without concomitant food ingestion.
Placebo + standard of care
Placebo tablets are identical in appearance to the active formulation. Placebo will be administered with the same treatment schedule.
Placebo
Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo can be taken with a glass of water (about 250 mL) and a light meal or snack, as it is preferable that placebo is taken with food. However, if the patient is unable to eat, the placebo may still be administered without concomitant food ingestion.
Interventions
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Reparixin
Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP can be taken with a glass of water (about 250 mL) and a light meal or snack, as it is preferable that reparixin is taken with food. However, if the patient is unable to eat, the study drug may still be administered without concomitant food ingestion.
Placebo
Administered orally three times a day (TID) as add-on therapy to standard of care up to 21 days.
Placebo can be taken with a glass of water (about 250 mL) and a light meal or snack, as it is preferable that placebo is taken with food. However, if the patient is unable to eat, the placebo may still be administered without concomitant food ingestion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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; Appendix 14.4.1);
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
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 (see section 5.5.2);
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
18 Years
ALL
No
Sponsors
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Dompé Farmaceutici S.p.A
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni Landoni, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione
Locations
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MD Banner University Medical Center /Arizona University
Tucson, Arizona, United States
UC Davis Medical Center - UC Davis Medical Group - Davis
Davis, California, United States
University of Southern California
Los Angeles, California, United States
UCI Health
Orange, California, United States
Denver Health
Denver, Colorado, United States
Nuvance Health
Danbury, Connecticut, United States
MedStar Health Research Institute-Hyatteville, Maryland
Washington D.C., District of Columbia, United States
Research Alliance Inc.
Clearwater, Florida, United States
University of Florida-Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory Johns Creek Hospital
Atlanta, Georgia, United States
Augusta University Health - Augusta University Medical Center
Augusta, Georgia, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Jesse Brown VA Medical Center
Chicago, Illinois, United States
Insight Hospital & Medical Center Chicago
Chicago, Illinois, United States
Northshore University HealthSystem
Evanston, Illinois, United States
Methodist Hospital
Gary, Indiana, United States
Norton Healthcare
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
NorthStar Anesthesia / Detroit Medical Center
Detroit, Michigan, United States
MidMichigan Medical Center - Midland
Midland, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
University Hospital - MU Healthcare
Columbia, Missouri, United States
Washington University, School of Medicine
St Louis, Missouri, United States
Mercy Research St Louis
St Louis, Missouri, United States
NYU Langone Hospital-Brooklyn
Brooklyn, New York, United States
New York University Langone Health
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University (OHSU) - Pulmonary Clinic
Portland, Oregon, United States
Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Hospitals of Southeast Texas
Beaumont, Texas, United States
Texoma Medical Center
Denison, Texas, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Virginia Commonwealth University Health
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Interzonal General de Agudos Dr Jose Penna
Bahía Blanca, Buenos Aires, Argentina
CEMIC
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Instituto Medico Platense
La Plata, Buenos Aires, Argentina
Clinica Independencia
Munro, Buenos Aires, Argentina
Sanatorio Finochietto
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Hospital Aleman
Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina
Sanatorio de la Cañada
Villa María, Córdoba Province, Argentina
Sanatorio Britanico S.A.
Rosario, Santa Fe Province, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, Argentina
Clinica Adventista Belgrano
Buenos Aires, , Argentina
Sanatorio Agote
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Clinica Chutro
Córdoba, , Argentina
Nuevo Hospital San Roque
Córdoba, , Argentina
Sanatorio Privado de la Cañada - Cordoba
Córdoba, , Argentina
Sanatorio Privado Duarte Quiroz De Clinica Colombo SA
Córdoba, , Argentina
Westmead Hospital
Sydney, New South Wales, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Kepler Universitatsklinikum Med Campus III
Linz, , Austria
KH der Barmherzigen Brüder Linz
Linz, , Austria
Medizinische Universitaet Wien, Medizinische Klinik I, Abteilung für Infektionskrankheiten und Tropenmedizin
Vienna, , Austria
Klinik Favoriten (Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital mit Gottfried von Preyer'schem Kinderspital)
Vienna, , Austria
Albeilung für Kardiologie und Pneumologie
Dachau, Bavaria, Germany
Medizinische Hochschule
Hanover, Lower Saxony, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Saxony, Germany
Universitätsmedizin Göttingen
Göttingen, Südniedersachsen, Germany
Universitaetsklinikum Jena
Jena, Thuringia, Germany
UOC Malattie dell'Apparato Respiratorio, Policlinico di Bari
Bari, , Italy
ASST - Ospedale Papa Giovanni XXIII - UOC Pneumologia
Bergamo, , Italy
Azienda Ospedaliera Universitaria di Bologna - Ospedale Sant'Orsola
Bologna, , Italy
Campus Universitario "Salvatore Venuta", Complesso Clinico, Padiglione B, 8° livello, Pneumologia
Catanzaro, , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Ferrara, , Italy
University Of Genoa - Ospedale Policlinico IRCCS San Martino di Genova
Genova, , Italy
IRCCS Istituto Clinico Humanitas U.O. Medicina D'Urgenza
Milan, , Italy
IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione
Milan, , Italy
ASST SANTI PAOLO E CARLO Ospedale San Paolo Struttura Complessa Malattie Infettive
Milan, , Italy
Università degli Studi di Milano-Ospedale "L.Sacco" Polo Universitario - ASST Fatebenefratelli Sacco
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda Dipartimento Malattie Infettive
Milan, , Italy
Fondazione Ca' Granda Policlinico Milano
Milan, , Italy
ASST-Monza Ospedale San Gerardo Malattie Infettive
Monza, , Italy
Azienda Ospedaliera Universitaria Federico II.
Napoli, , Italy
Clinica Pneumologica "L. Vanvitelli" - Osp Monaldi
Napoli, , Italy
Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, , Italy
Università degli studi di Padova, Unità Malattie Respiratorie
Padua, , Italy
AOUP "P.Giaccone" - UOC Pneumologia
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia, Dipartimento di Scienze Mediche e Malattie Infettive
Pavia, , Italy
Struttura semplice di terapia demi-intensiva respiratoria S.C. di pneumologia AO IRCCS Santa Maria Nuova
Reggio Emilia, , Italy
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Dicle University, Medical Faculty
Diyarbakır, , Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma Ve Uygulama Hastanesi
Gaziantep, , Turkey (Türkiye)
Acibadem Atakent Hospital
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine
Izmir, , Turkey (Türkiye)
Kayseri State Hospital
Kayseri, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
Inonu Uni.Med.Faculty
Malatya, , Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.
Trabzon, , Turkey (Türkiye)
Countries
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References
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Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.
Other Identifiers
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2021-006951-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REP0321
Identifier Type: -
Identifier Source: org_study_id
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