Add-on Reparixin in Adult Patients With ARDS

Exclusion Criteria

• •1. 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
• •2. 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)
• •3. Participation in another interventional clinical trial.
• •4. Patients that are clinically determined to have a high likelihood of death within the next 24 hours based on PI's estimation.
• •5. Currently receiving ECMO or high frequency oscillatory ventilation.
• •6. Anticipated extubation within 24 hours of screening. (In such cases re-screening is allowed if the patient is within the enrollment window).
• •7. 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).
• •8. Anticipated transfer to a hospital not participating in the trial within 72 hours of screening.
• •9. 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).
• •10. History of:
• •1. Documented allergy/hypersensitivity to sulfonamides, ibuprofen and other COX-1 and 2 inhibitors, and to the study product and/or its excipients.
• •2. Lactase deficiency, galactosemia or glucose-galactose malabsorption.
• •3. History of peptic ulcer, GI bleeding or perforation due to previous NSAID therapy.
• •11. Active bleeding (excluding menses) from uncontrolled site that cannot be definitively resolved prior to enrollment.
• •12. Pregnant or lactating women.
• •13. 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 non able 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 patient when/if he/she is able to do so.