BridgeMD
Phase 2, randomized, double-blinded, placebo-controlled, multicenter study to assess efficacy and safety of reparixin as additional therapy in adult patients with Acute Respiratory Distress Syndrome
EU CTIS ID: 2024-512621-88-00
What this study is testing
To characterize the efficacy of reparixin in ameliorating lung injury and systemic inflammation and expediting clinical recovery and liberation from mechanical ventilation in adult patients with moderate to severe ARDS (PaO2/FIO2 ratio ≤ 200). Furthermore, to assess the effect of reparixin on systemic biomarkers linked to a hyper-inflammatory ARDS phenotype. Safety objectives: To evaluate the safety of reparixin vs. placebo in patients enrolled in the study.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed Informed Consent, according to local guidelines and regulations.
- Male and female adults (>18 years old).
- Mechanically ventilated (invasive) patients with PaO2/FIO2 ratio ≤ 200 in the presence of PEEP of ≥5 cm H2O.
- Respiratory failure not fully explained by cardiac failure or fluid overload (if acute Congestive Heart Failure exacerbation is identified as part of the clinical picture this should be addressed effectively and as soon as possible before the patient can be enrolled).
- Bilateral radiologic opacities consistent with pulmonary edema on the frontal chest x-ray (CXR) radiograph, or bilateral ground glass opacities on a chest CT scan.
- ≤48 hours from fulfilling above ARDS criteria (if a patient is transferred from a non-participating hospital to a participating site, a 12-hour period beyond the 48 hours is allowed)
You likely can't join if
- Moderate-Severe chronic hepatic disease (as verified by a previously known Child-Pugh score ≥7). If baseline Child-Pugh score is not known, it should not be calculated while the patient is acutely ill. In that case, the patient is excluded on the basis of: ALT/AST ≥ 3x ULN and total bilirubin > 2x ULN or ALT/AST ≥ 5x ULN.
- History of: a) Documented allergy/hypersensitivity to sulfonamides, ibuprofen and other COX-1 and 2 inhibitors, and to the study product and/or its excipients. b) Lactase deficiency, galactosemia or glucose-galactose malabsorption. c) History of peptic ulcer, GI bleeding or perforation due to previous NSAID therapy.
- Active bleeding (excluding menses) from an uncontrolled site that cannot be definitively resolved prior to enrollment.
- Pregnant or lactating women.
- Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception during the study and up to 30 days after the last IMP dose. For patients unable to personally consent to above due to complications of acute illness and/or its treatment, assurances for the above must be given by LR and reiterated by the patient when/if he/she is able to do so.
- Severe chronic renal dysfunction: eGFR (2021 CKD-EPI) < 30 mL/min/1.73m2 . If baseline (chronic) renal function is not known, the patient is only excluded if in need of acute renal replacement therapy (currently on RRT or to be imminently placed on RRT).
See the full eligibility criteria
Who can join
- Signed Informed Consent, according to local guidelines and regulations.
- Male and female adults (>18 years old).
- Mechanically ventilated (invasive) patients with PaO2/FIO2 ratio ≤ 200 in the presence of PEEP of ≥5 cm H2O.
- Respiratory failure not fully explained by cardiac failure or fluid overload (if acute Congestive Heart Failure exacerbation is identified as part of the clinical picture this should be addressed effectively and as soon as possible before the patient can be enrolled).
- Bilateral radiologic opacities consistent with pulmonary edema on the frontal chest x-ray (CXR) radiograph, or bilateral ground glass opacities on a chest CT scan.
- ≤48 hours from fulfilling above ARDS criteria (if a patient is transferred from a non-participating hospital to a participating site, a 12-hour period beyond the 48 hours is allowed)
- Females of child-bearing potential who are sexually active must be willing not to get pregnant within 30 days after the last Investigational Medicinal Product (IMP) dose and must agree to at least one of the following reliable methods of contraception: • Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives from at least2 months before the screening visit until 30 days after the last IMP dose; • A sterile sexual partner; • Abstinence. For patients unable to personally consent to the above, due to complications of acute illness and/or its treatment, assurances for the above must be given by LR and reiterated by the patient when/if she is able to do so. Female participants of non-child-bearing potential or in postmenopausal status for at least 1 year will be admitted. For all female subjects with child-bearing potential, pregnancy test results must be negative before first drug intake.
What rules you out
- Moderate-Severe chronic hepatic disease (as verified by a previously known Child-Pugh score ≥7). If baseline Child-Pugh score is not known, it should not be calculated while the patient is acutely ill. In that case, the patient is excluded on the basis of: ALT/AST ≥ 3x ULN and total bilirubin > 2x ULN or ALT/AST ≥ 5x ULN.
- History of: a) Documented allergy/hypersensitivity to sulfonamides, ibuprofen and other COX-1 and 2 inhibitors, and to the study product and/or its excipients. b) Lactase deficiency, galactosemia or glucose-galactose malabsorption. c) History of peptic ulcer, GI bleeding or perforation due to previous NSAID therapy.
- Active bleeding (excluding menses) from an uncontrolled site that cannot be definitively resolved prior to enrollment.
- Pregnant or lactating women.
- Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception during the study and up to 30 days after the last IMP dose. For patients unable to personally consent to above due to complications of acute illness and/or its treatment, assurances for the above must be given by LR and reiterated by the patient when/if he/she is able to do so.
- Severe chronic renal dysfunction: eGFR (2021 CKD-EPI) < 30 mL/min/1.73m2 . If baseline (chronic) renal function is not known, the patient is only excluded if in need of acute renal replacement therapy (currently on RRT or to be imminently placed on RRT).
- Participation in another interventional clinical trial.
- Patients that are clinically determined to have a high likelihood of death within the next 24 hours based on PI's estimation.
- Currently receiving ECMO or high frequency oscillatory ventilation.
- Anticipated extubation within 24 hours of screening. (In such cases, re-screening is allowed if the patient is within the enrollment window).
- Evidence of GI dysmotility as demonstrated by presence of all the following: persistent gastric distention and enteral feeding intolerability and persistent gastric residuals >500 ml).
- Anticipated transfer to a hospital not participating in the trial within 72 hours of screening.
- Decision to withhold or withdraw life-sustaining treatment (patients may still be eligible however if they are committed to full support except cardiopulmonary resuscitation if cardiac arrest occurs).
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.