Status and phase
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Identifiers
About
Primary objective:
Secondary objectives:
Safety objectives:
Full description
Multinational, multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase III trial.
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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):
Need for non-invasive supplemental oxygen (NIAID-OS 5-6; Appendix 14.4.1);
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:
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
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 (see section 5.5.2);
Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening
History of:
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:
Current hospital stay >72h
Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism
Primary purpose
Allocation
Interventional model
Masking
526 participants in 2 patient groups, including a placebo group
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Central trial contact
Enrico Minnella, MD; Sophie Toya, MD
Data sourced from clinicaltrials.gov
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