Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Infectious Pneumonia, Severe COVID-19

In brief

Primary objective: \- To compare the efficacy of reparixin vs. placebo in the proportion of patients dead or requiring IMV (or ECMO) by Day 28. Key secondary objectives: * To compare the efficacy of reparixin vs placebo in all-cause mortality at day 180. * To compare the efficacy of reparixin vs placebo in proportion of patients alive and discharged at day 28 * To compare the efficacy of reparixin vs placebo in ventilatory-free days at day 28. * To compare the efficacy of reparixin vs placebo in proportion of patients with IMV (or ECMO) by day 28. * To compare the efficacy of reparixin vs placebo in length of primary hospital stay. Other efficacy objectives \- To compare the efficacy of reparixin vs placebo on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: \- To evaluate safety and tolerability of oral reparixin versus placebo in the specific clinical setting.

Key facts

Study ID

NCT05254990

Run by

Dompé Farmaceutici S.p.A

People needed

414

Starts

2022-04-27

Expected to finish

2024-09-27

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent signed
• Male and female ≥18 years old;
• Patients hospitalized for clinically suspected CAP, defined as the occurrence of (within 48h from hospital admission):
• at least 1 of the following signs/symptoms: dyspnea, cough, purulent sputum, crackles (rales) and/or rhonchi
• body temperature > 38°C or <36°C (before or during admission) or leucocytosis (> local ULN)
• new/increased pulmonary infiltrate(s) by chest imaging
• Need for non-invasive supplemental oxygen (NIAID-OS 5-6);
• SpO2 <92% at room air, or PaO2/FiO2 (or SpO2/FiO2) <300;
• 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:
• 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
• 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
• A male sexual partner who agrees to use a male condom with spermicide
• 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.

You may not qualify if…

• Treatment with IMV or ECMO (NIAID-OS 7);
• Hepatic dysfunction: ALT or AST > 5 ULN; history of chronic hepatic disease (defined with Child-Pugh score B or C);
• Renal dysfunction: estimated glomerular filtration rate (eGFR, MDRD) <50 mL/min/1.73 m2, or need for haemodialysis or hemofiltration;
• 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)
• Treatment with prohibited medication within 5 half-lives, and inability to stop during treatment period;
• Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening
• History of:
• 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)
• lactase deficiency, galactosemia or glucose-galactose malabsorption
• gastrointestinal bleeding or perforation due to previous NSAIDs therapy or recurrent peptic ulcer/haemorrhage
• allergy to reparixin or any component of the IMP formulation
• Active bleeding or bleeding diathesis (excluding menses), prior intracranial haemorrhage
• Participation in other interventional clinical trials
• Clinical condition not compatible with oral administration of the study drug
• Pregnancy:
• positive or missing pregnancy test before first drug intake or day 1;
• pregnant or lactating women;
• 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
• Current hospital stay >72h
• Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism

Where it is running

• UCI Health — Orange, California, United States
• Denver Health — Denver, Colorado, 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
• 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
• Methodist Hospital — Gary, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, 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
• 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
• MD Banner University Medical Center /Arizona University — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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