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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05254990
Registration number
NCT05254990
Ethics application status
Date submitted
22/02/2022
Date registered
24/02/2022
Date last updated
24/10/2024
Titles & IDs
Public title
Reparixin add-on Therapy to Std Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia
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Scientific title
Reparixin 1200 mg TID as add-on to SoC to Limit Disease Progression in Hospitalised Patients With COVID-19 and Other Community-Acquired Pneumonia. A Multicentre, Randomised, Double-blinded, Placebo-controlled, Phase III Trial (REPAVID-22)
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Secondary ID [1]
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2021-006951-32
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Secondary ID [2]
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REP0321
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infectious Pneumonia
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Severe COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Infection
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Studies of infection and infectious agents
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Reparixin
Other interventions - Placebo
Experimental: 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.
Placebo comparator: Placebo + standard of care - Placebo tablets are identical in appearance to the active formulation. Placebo will be administered with the same treatment schedule.
Treatment: Drugs: 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.
Other interventions: 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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of patients dead or requiring Invasive Mechanical Ventilation (IMV) or Extracorporeal Membrane Oxygenation (ECMO) by day 28 [NIAID-OS 7].
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Assessment method [1]
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NIAID-OS = National Institute of Allergy and Infectious Disease - Ordinal Scale
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Timepoint [1]
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Day 28
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Secondary outcome [1]
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All-cause mortality at day 180
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Assessment method [1]
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Timepoint [1]
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Day 180
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Secondary outcome [2]
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Proportion of patients alive and discharged at day 28
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Assessment method [2]
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Timepoint [2]
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Day 28
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Secondary outcome [3]
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Ventilatory-free days (VFD) at day 28
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Assessment method [3]
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Number of days from Day 0 to Day 28 when the patient will alive and free of invasive ventilation. In case of multiple periods of IMV during the first 28 days, the total duration of ventilation considered all periods of ventilation during the index admission. Patients who will die within 28 days or will be still on invasive ventilation after 28 days will score zero VFDs18
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Timepoint [3]
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Day 28
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Secondary outcome [4]
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Occurrence of IMV (or ECMO) by day 28
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Assessment method [4]
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Timepoint [4]
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Day 28
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Secondary outcome [5]
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Length of primary hospital stay
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Assessment method [5]
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Timepoint [5]
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Throughout the trial
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Secondary outcome [6]
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Clinical failure by day 3 and day 7
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Assessment method [6]
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Clinical failure will be defined as the occurrence of IMV/ECMO or vasopressor, or death
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Timepoint [6]
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day 3 and day 7
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Secondary outcome [7]
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28-day ICU-free days
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Assessment method [7]
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Timepoint [7]
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Day 28
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Secondary outcome [8]
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Days free of IMV/ECMO (number of days with NIAID-OS 1-6) at day 28
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Assessment method [8]
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Timepoint [8]
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Day 28
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Secondary outcome [9]
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Duration of antibiotic therapy (days) at day 28
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Assessment method [9]
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Timepoint [9]
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Day 28
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Secondary outcome [10]
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Hospital free days
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Assessment method [10]
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Timepoint [10]
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Day 28
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Secondary outcome [11]
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Proportion of patients recovered
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Assessment method [11]
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downward shift from screening of =2 points on the NIAID-OS or live discharge from hospital)
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Timepoint [11]
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days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge
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Secondary outcome [12]
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Proportion of patients worsening
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Assessment method [12]
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upward shift from screening of at least \>1 point of the NIAID-OS)
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Timepoint [12]
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days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge
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Secondary outcome [13]
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PO2/FiO2
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Assessment method [13]
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Timepoint [13]
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days 3, 7±1, 14±2, 21±2, 28 ±2 or at hospital discharge
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Secondary outcome [14]
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All-cause mortality
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Assessment method [14]
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Timepoint [14]
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Days 28 and 90
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Secondary outcome [15]
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Hospital re-admission by day 90 and 180
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Assessment method [15]
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Timepoint [15]
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Days 90 and 180
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Secondary outcome [16]
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Time to discharge or to a NEWS of = 2 (for 24 hours), whichever occurs first
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Assessment method [16]
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Timepoint [16]
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Day 28
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Secondary outcome [17]
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Change in inflammatory markers (LDH, CRP, ferritin; D-dimer, PCT) and cytokines
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Assessment method [17]
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Timepoint [17]
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Days 3, 7±1, 14±2, 21±2, 28±2 or at hospital discharge]
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Secondary outcome [18]
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Change in quality of life using EuroQol-5-dimensions-5 levels (EQ-5D-5L) questionnaire
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Assessment method [18]
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The EQ-5D-5L asks patients to indicate whether they have no, slight, moderate, severe, extreme problems on each of five dimensions of health: mobility; self-care; usual activities; pain/discomfort; anxiety/depression.
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Timepoint [18]
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90±7 and 180±14 days
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Secondary outcome [19]
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Duration of IMV and/or ECMO at 90 and 180 days
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Assessment method [19]
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Timepoint [19]
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Days 90 and 180
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Secondary outcome [20]
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ICU admission at 90 and 180 days
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Assessment method [20]
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Timepoint [20]
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Days 90 and 180
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Secondary outcome [21]
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ICU length of stay at 90 and 180 days
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Assessment method [21]
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Timepoint [21]
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Days 90 and 180
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Secondary outcome [22]
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Hospital length of stay at 90 and 180 days
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Assessment method [22]
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Timepoint [22]
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Days 90 and 180
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Secondary outcome [23]
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Occurrence of infections at 90 and 180 days
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Assessment method [23]
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Timepoint [23]
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Days 90 and 180
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Eligibility
Key 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; 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 (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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/09/2024
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Sample size
Target
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Accrual to date
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Final
409
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Westmead Hospital - Sydney
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Recruitment hospital [2]
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Mater Hospital Brisbane - South Brisbane
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Recruitment hospital [3]
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Gold Coast University Hospital - Southport
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [5]
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Royal Melbourne Hospital - Parkville
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2145 - Sydney
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment outside Australia
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Arizona
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Colorado
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Connecticut
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Missouri
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Ciudad Autonoma De Buenos Aires
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Trabzon
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Dompé Farmaceutici S.p.A
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary objective: - 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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Trial website
https://clinicaltrials.gov/study/NCT05254990
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Giovanni Landoni, MD
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Address
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IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
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Sophie Toya, MD
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Address
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Phone
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+1 219 427 2474
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05254990
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