A Phase 2 interventional study of Reparixin 600mg and Matching Placebo in Acute Respiratory Distress Syndrome, Adult, sponsored by Dompé Farmaceutici S.p.A. Completed at 40 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Dompé Farmaceutici S.p.A · Phase 2, Interventional, and Treatment
Study objectives
Phase 2, randomized, double-blinded, placebo controlled, multicenter study. All patients will receive therapy in line with current standard-of-care as it pertains to ARDS management (protocolized ventilator management will be made available to all sites in accordance with currently accepted standard of care). Patients will be randomized (1:1) to either reparixin or placebo. Duration of treatment will be 14 days. In this study the IMP will be either reparixin or matched placebo, which will be provided in the form of tablets to be disintegrated for naso-gastric tube administration or administered orally after extubation and between extubation and day 14 should the patient be able to swallow. In such cases the IMP may be administered either intact or crushed and mixed with a vehicle as per speech swallow evaluation.
The study will consist of 4 study periods:
Screening Randomization and Baseline assessments, Treatment (14 days with discretionary extension up to 21 days), Follow-up (up to 28 days or hospital discharge, whichever occurs first, and then up to day-60).
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's enrollment of 66 is close to the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Dompé Farmaceutici S.p.A is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 18 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of who are sexually active must be willing not to get pregnant within 30 days after the last Medicinal Product (IMP) dose and must agree to at least one of the following reliable methods of :
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:
History of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reparixin tablets 1200 mg TID (2 tablets x 600 mg TID) as add-on to the standard of care (SoC).
Drug: Reparixin 600mg
Placebo tablets with the same schedule of reparixin, as add-on to the standard of care (SoC)
Other: Matching Placebo
Reparixin 600 mg tablets, administered crushed through nasogastric tube at the dose of 1200 mg TID (2 tablets TID administered approximately about every 8 hours) as add-on to the standard of care. After extubation and if the patient can swallow, reparixin may be administered orally. Total duration of the treatment: 14 days
Also known as: REP
Placebo tablets. Administered crushed through nasogastric tube with the same schedule as reparixin as add-on to the standard of care. After extubation and if the patient can swallow placebo may be administered orally. Total duration of the treatment: 14 days
Also known as: Control
Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment
Oxygenation Index is defined as Mean Airway Pressure multiplied by (Fraction of Inspired Oxygen\[FiO2\]) x (100)/(Partial Pressure of Oxygen\[PaO2\]). It is a measure of efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. Baseline was defined as last measurement collected prior to investigational medicinal product intake. Change from baseline was defined as post-baseline assessment minus baseline value. Adjusted means and 95% confidence interval from an ANOVA model with multiple imputation (MI) for missing data have been presented.
Time frame: Baseline to Day 7
Ventilator-Free Days (VFD)
Ventilator free days (VFDs) through Day 28 were defined as the number of days from the first IMP intake during which the participant was alive and free of invasive mechanical ventilation. Participants who died before or at Day 28 were assigned a value of 0 ventilator-free days, in accordance with the estimand definition. Adjusted means and 95% confidence interval from an ANOVA model with MI for missing data have been presented.
Time frame: At Day 28
Change in Oxygenation Index (OI) From Baseline to Day 4
Oxygenation Index (OI) is defined as Mean Airway Pressure multiplied by (FiO2) x (100) / (PaO2). It is a measure of the efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to the estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. For Day 4, no imputation or adjusted means were applied; only observed data from participants with available measurements were used. Baseline was defined as the last measurement collected prior to IMP intake. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Time frame: Baseline to Day 4
Change From Baseline of Acute Lung Injury (ALI) Score
Acute Lung Injury (ALI) Score is a composite 4-point scoring system validated by the National Heart, Lung, and Blood Institute (NHLBI) acute respiratory distress syndrome (ARDS) Network that considers PaO2/FiO2, the level of positive end-expiratory pressure (PEEP), lung/respiratory compliance \[plateau airway pressure minus PEEP/Tidal Volume (TV)\], and the extent of pulmonary infiltrates on the chest radiograph. Each criterion was scored from 0-4 based on the severity of the condition. The final score was calculated by dividing the total score by the number of criteria used. A score of 0 indicates no lung injury, a score between 0.1 to 2.5 indicates mild to moderate lung injury and a score of \>2.5 indicates severe lung injury (ARDS). Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Time frame: Baseline and at Days 2, 3, 7 and 14
Change From Baseline of Sequential Organ Failure Assessment (SOFA) Score
The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). The score ranges for each system organ classes range from 0 to 4. SOFA score was calculated every 24 hours using (for each organ system) the worst variable recorded within the same 24 hours. The best possible score corresponds to 0 whereas the worst score corresponds to 24. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Time frame: Baseline and at Days 2, 3, 7 and 14
Change From Baseline of Ventilatory Ratio
The Ventilatory Ratio (VR) is a simple, non-invasive bedside index used to monitor the efficiency of carbon dioxide (CO2) clearance in mechanically ventilated participants, particularly those with ARDS. VR = \[minute ventilation (ml/min) × PaCO2 (mm Hg)\] / \[predicted body weight × 100 (ml/min) × 37.5 (mm Hg)\] VR is a unitless ratio, and a value approximating 1 would represent normal ventilating lungs. An elevated value of VR would represent either increased pulmonary dead space, increased VCO2 or both. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Time frame: Baseline and at Days 2, 3, 7 and 14
Number of Participants Requiring Extracorporeal Membrane Oxygenation (ECMO) at Day 14
Extracorporeal Membrane Oxygenation (ECMO) is an advanced form of temporary life support used for participants with life-threatening heart or lung failure that has not responded to conventional treatments. It functions as a modified heart-lung bypass machine, circulating blood outside the body to add oxygen and remove carbon dioxide before returning it to the participants. Use of ECMO between first investigational medicinal product intake and Day 14 was counted.
Time frame: At Day 14
Percentage of Participants Using Vasoactive Medications at Day 14
Use of vasoactive medication is defined as the percentage of participants who received ≥1 vasoactive medication at any time from first IMP intake (Day 1) up to and including Day 14 (inclusive window), divided by the number of participants in the analysis population. Use of Vasoactive Medications is collected in "Ventilation - Specific Information" CRF Daily assessments through extubation. An event is recorded as "Yes" if vasoactive medication use is reported at any daily assessment performed between the date/time of first IMP intake (Day 1) and Day 14 (Day 1 + 13 days), inclusive. If no use is reported during this period, the event is recorded as "No" provided the last available assessment occurs on or after Day 12 (allowing a ±2-day window for the Day 14 visit). The event is recorded as missing if the last available assessment occurs before Day 12.
Time frame: At Day 14
Change From Baseline of Chest X-ray (CXR) Assessment of Pulmonary Edema by Radiographic Assessment of Lung Edema (RALE) Score
Radiographic Assessment of Lung Edema (RALE) score is a validated, semi-quantitative tool for quantifying pulmonary edema and ARDS severity using chest X-rays (CXR). It is calculated by dividing the lung fields on the chest radiograph into four quadrants. Each quadrant was assigned a number, and the extent of alveolar opacities (the consolidation score, from 0 to 4) and density of alveolar opacities (the density score, from 1 to 3) was determined. If the consolidation score was 0, the density score was 0. The final RALE score was the sum of the product of the consolidation and density score for each quadrant. Thus, the final RALE score ranged from minimum 0 to maximum 48. Higher RALE scores indicate more severe edema and poorer outcomes. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
Time frame: Baseline and at Days 2, 3, 7 and 14
Percentage of Participants Achieving Pressure Support Ventilation Equal to 5 cm H20 With PEEP Equal to 5 cm H20 for 2 Hours (Measure of Weaning)
Continuous Positive Airway Pressure (CPAP) is defined as use of pressure support ventilation equal to 5 cmH2O with PEEP equal to 5 cmH2O for 2 hours. Each qualifying CPAP trial recorded in the Ventilation Specific Information CRF is counted as one weaning attempt. By Day 28: An event is recorded as "Yes" if at least one CPAP weaning attempt (\>0) is reported between Day 1 (first IMP intake) and Day 28 (Day 1 + 27 days). The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. By Hospital Discharge: An event is recorded as "Yes" if at least one CPAP weaning attempt (\>0) is reported between Day 1 and hospital discharge. The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. Hospital discharge date is obtained from EOS or, if missing, from the Hospital Discharge visit date; if unavailable, hospitalization is assumed ongoing.
Time frame: At Day 28 and Hospital Discharge (Up to Day 30)
Intensive Care Unit (ICU)-Free Days
Intensive Care Unit (ICU) free days were defined as number of calendar days from first IMP intake during which a participant was alive and not hospitalized in an ICU. ICU-free days at Day 28 were calculated as 28 minus total number of ICU days up to Day 28, with negative values set to 0. Participants who died on or before Day 28 were assigned 0 ICU-free days. If a participant was discharged before Day 28 and died after discharge but before Day 28, ICU-free days at Day 28 equaled ICU-free days at discharge. Endpoint was set to missing if participant was alive but followed for fewer than 26 days or if required data were missing. ICU-free days at hospital discharge were calculated as (discharge date - first IMP intake date + 1) minus total ICU days up to discharge, with negative values set to 0. Participants who died during hospitalization were assigned 0 ICU-free days. If discharge did not occur and death occurred after Day 28, ICU-free days at discharge equaled ICU-free days at Day 28.
Time frame: At Day 28 and Hospital Discharge (Up to Day 30)
Hospital-free Days
Hospital-free days are a participant-centered metric defining the number of days a participant stays alive outside an acute-care hospital. If the participant was alive at Day 28 (last available day ≥26), hospital-free days were calculated as 28 minus total hospital days up to Day 28. If the participant died on or before Day 28, hospital-free days were set to 0.
Time frame: Up to Day 28
Percentage of Participants With Tracheostomies
Percentage of participants who underwent a tracheostomy between Day 1 and Day 28 or hospital discharge, has been presented. The event is recorded as "Yes" if a tracheostomy occurred during this period, "No" if no procedure occurred and the visit/discharge date is available and missing if both the procedure date and visit/discharge date are unavailable.
Time frame: At Day 28 and Hospital Discharge (Up to Day 30)
Percentage of Participants Transferred to a Long-Term Acute Care (LTAC) Facility
An LTAC is a Long Term Acute Care Hospital, a facility that specializes in the treatment of participants with serious medical conditions, including patients with ongoing needs for mechanical ventilation, but who no longer require intensive care or extensive diagnostic procedures. The participants in LTAC are transferred there directly from the intensive care unit because they require more care than they can receive in a rehabilitation center, skilled care facility or at home.
Time frame: From Day 1 of first IMP intake through Day 28 and Hospital Discharge (Up to Day 30)
Percentage of Participants Who Died by Day 28 and Day 60
Percentage of death by Day 28 and Day 60 has been reported. The event is recorded as "Yes" if death occurred within the period, "No" if the participant was alive with last available assessment at or beyond Day 28 or Day 60.
Time frame: Up to Day 28 and 60
Hospital Discharge by Day 28
A participant was considered discharged alive by Day 28 if hospital discharge occurred on or before Day 28, regardless of vital status after discharge. Participants were considered not discharged alive by Day 28 if they died without a recorded discharge date, were discharged after Day 28, had a missing discharge date with sufficient follow-up (last available day ≥26), or had a discharge date equal to the date of death. The endpoint was set to missing if the discharge date was missing and the participant was alive but followed for fewer than 26 days. Percentage of participants discharged from hospital by Day 28 has been presented.
Time frame: Day 28
Change From Baseline in Plasma Biomarkers: Interleukin-6 (IL-6), IL-8, and Plasma Tumor Necrosis Factor Receptor 1 (TNFr-1)
Plasma biomarker levels for Interleukin -6 (IL-6), IL-8 and plasma Tumor Necrosis Factor Receptor 1 (TNFr-1) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
Time frame: Baseline and at Days 3, 7 and 14
Change From Baseline in Plasma Biomarkers: PAI-1, ICAM-1, and RAGE
Plasma biomarker levels of plasminogen activator inhibitor-1 (PAI-1), intercellular adhesion molecule-1 (ICAM-1), and receptor for advanced glycation end products (RAGE) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
Time frame: Baseline and at Days 3, 7 and 14
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (Serious TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention. A TEAE is defined as any untoward medical occurrence that begins or worsens in intensity or frequency after the initiation of a treatment (e.g., drug, device, or procedure) in a clinical study. A Serious TEAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization.
Time frame: Up to 26 Months
This was a phase 2, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy and safety of Reparixin as add-on therapy to standard of care in adult participants with acute respiratory distress syndrome (ARDS).
| Milestone | Reparixin | Placebo |
|---|---|---|
| Started | 35 | 31 |
| Completed | 19 | 19 |
| Not completed | 16 | 12 |
| Withdrew: Death | 12 | 11 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Oxygenation Index is defined as Mean Airway Pressure multiplied by (Fraction of Inspired Oxygen\[FiO2\]) x (100)/(Partial Pressure of Oxygen\[PaO2\]). It is a measure of efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. Baseline was defined as last measurement collected prior to investigational medicinal product intake. Change from baseline was defined as post-baseline assessment minus baseline value. Adjusted means and 95% confidence interval from an ANOVA model with multiple imputation (MI) for missing data have been presented.
| Index | Reparixin | Placebo |
|---|---|---|
| Change in Oxygenation Index (OI) From Baseline to Day 7 of Treatment | -5.3 (-8.4 to -2.3) | -6.6 (-9.6 to -3.6) |
Ventilator free days (VFDs) through Day 28 were defined as the number of days from the first IMP intake during which the participant was alive and free of invasive mechanical ventilation. Participants who died before or at Day 28 were assigned a value of 0 ventilator-free days, in accordance with the estimand definition. Adjusted means and 95% confidence interval from an ANOVA model with MI for missing data have been presented.
| Days | Reparixin | Placebo |
|---|---|---|
| Ventilator-Free Days (VFD) | 11.7 (7.3 to 16.1) | 12.6 (8.2 to 17.0) |
Oxygenation Index (OI) is defined as Mean Airway Pressure multiplied by (FiO2) x (100) / (PaO2). It is a measure of the efficiency of oxygen utilization in the body, with lower values indicating better oxygenation. OI values can range from 0 to 1000, with values below 25 generally associated with more favorable clinical outcomes. OI at Day 7 was derived according to the estimand definition. If a participant died before or at Day 7 and OI was missing, an unfavorable value was imputed. If a participant was extubated at Day 7 and OI was not evaluable, a favorable value was imputed. In all other cases, OI at Day 7 was considered missing. For Day 4, no imputation or adjusted means were applied; only observed data from participants with available measurements were used. Baseline was defined as the last measurement collected prior to IMP intake. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
| Index | Reparixin | Placebo |
|---|---|---|
| Change in Oxygenation Index (OI) From Baseline to Day 4 | -3.969 ± 9.0398 | -7.241 ± 11.4516 |
Acute Lung Injury (ALI) Score is a composite 4-point scoring system validated by the National Heart, Lung, and Blood Institute (NHLBI) acute respiratory distress syndrome (ARDS) Network that considers PaO2/FiO2, the level of positive end-expiratory pressure (PEEP), lung/respiratory compliance \[plateau airway pressure minus PEEP/Tidal Volume (TV)\], and the extent of pulmonary infiltrates on the chest radiograph. Each criterion was scored from 0-4 based on the severity of the condition. The final score was calculated by dividing the total score by the number of criteria used. A score of 0 indicates no lung injury, a score between 0.1 to 2.5 indicates mild to moderate lung injury and a score of \>2.5 indicates severe lung injury (ARDS). Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
| score on a scale | Reparixin | Placebo |
|---|---|---|
| Day 2 | -0.338 ± 0.7392 | -0.339 ± 0.6542 |
| Day 3 | -0.250 ± 0.5288 | -0.410 ± 0.8309 |
| Day 7 | -0.771 ± 0.7302 | -0.767 ± 1.1479 |
| Day 14 | -0.917 ± 1.0104 | -0.354 ± 0.7465 |
The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). The score ranges for each system organ classes range from 0 to 4. SOFA score was calculated every 24 hours using (for each organ system) the worst variable recorded within the same 24 hours. The best possible score corresponds to 0 whereas the worst score corresponds to 24. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
| score on a scale | Reparixin | Placebo |
|---|---|---|
| Day 2 | -0.7 ± 2.48 | -0.3 ± 1.89 |
| Day 3 | -0.6 ± 2.52 | -0.9 ± 2.64 |
| Day 7 | -0.8 ± 3.54 | -2.3 ± 3.04 |
| Day 14 | -3.6 ± 5.68 | -2.3 ± 5.74 |
The Ventilatory Ratio (VR) is a simple, non-invasive bedside index used to monitor the efficiency of carbon dioxide (CO2) clearance in mechanically ventilated participants, particularly those with ARDS. VR = \[minute ventilation (ml/min) × PaCO2 (mm Hg)\] / \[predicted body weight × 100 (ml/min) × 37.5 (mm Hg)\] VR is a unitless ratio, and a value approximating 1 would represent normal ventilating lungs. An elevated value of VR would represent either increased pulmonary dead space, increased VCO2 or both. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
| Ratio | Reparixin | Placebo |
|---|---|---|
| Day 2 | -0.002 ± 0.7684 | -0.041 ± 0.8384 |
| Day 3 | 0.101 ± 0.7480 | 0.069 ± 0.8728 |
| Day 7 | -0.260 ± 0.7597 | -0.082 ± 1.2672 |
| Day 14 | 0.363 ± 0.4426 | -0.005 ± 0.8230 |
Extracorporeal Membrane Oxygenation (ECMO) is an advanced form of temporary life support used for participants with life-threatening heart or lung failure that has not responded to conventional treatments. It functions as a modified heart-lung bypass machine, circulating blood outside the body to add oxygen and remove carbon dioxide before returning it to the participants. Use of ECMO between first investigational medicinal product intake and Day 14 was counted.
| Participants | Reparixin | Placebo |
|---|---|---|
| Number of Participants Requiring Extracorporeal Membrane Oxygenation (ECMO) at Day 14 | 0 | 4 |
Use of vasoactive medication is defined as the percentage of participants who received ≥1 vasoactive medication at any time from first IMP intake (Day 1) up to and including Day 14 (inclusive window), divided by the number of participants in the analysis population. Use of Vasoactive Medications is collected in "Ventilation - Specific Information" CRF Daily assessments through extubation. An event is recorded as "Yes" if vasoactive medication use is reported at any daily assessment performed between the date/time of first IMP intake (Day 1) and Day 14 (Day 1 + 13 days), inclusive. If no use is reported during this period, the event is recorded as "No" provided the last available assessment occurs on or after Day 12 (allowing a ±2-day window for the Day 14 visit). The event is recorded as missing if the last available assessment occurs before Day 12.
| Percentage of Participants | Reparixin | Placebo |
|---|---|---|
| Percentage of Participants Using Vasoactive Medications at Day 14 | 77.4 | 90.3 |
Radiographic Assessment of Lung Edema (RALE) score is a validated, semi-quantitative tool for quantifying pulmonary edema and ARDS severity using chest X-rays (CXR). It is calculated by dividing the lung fields on the chest radiograph into four quadrants. Each quadrant was assigned a number, and the extent of alveolar opacities (the consolidation score, from 0 to 4) and density of alveolar opacities (the density score, from 1 to 3) was determined. If the consolidation score was 0, the density score was 0. The final RALE score was the sum of the product of the consolidation and density score for each quadrant. Thus, the final RALE score ranged from minimum 0 to maximum 48. Higher RALE scores indicate more severe edema and poorer outcomes. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was defined as the difference between the value at each post-baseline assessment and the baseline value.
| Scores on a scale | Reparixin | Placebo |
|---|---|---|
| Day 2 | -5.0 ± 6.20 | 6.5 ± 8.10 |
| Day 3 | -4.0 ± 6.04 | 1.0 ± 7.04 |
| Day 7 | -10.1 ± 7.24 | -4.4 ± 3.36 |
| Day 14 | -10.2 ± 13.07 | -2.5 ± 3.54 |
Continuous Positive Airway Pressure (CPAP) is defined as use of pressure support ventilation equal to 5 cmH2O with PEEP equal to 5 cmH2O for 2 hours. Each qualifying CPAP trial recorded in the Ventilation Specific Information CRF is counted as one weaning attempt. By Day 28: An event is recorded as "Yes" if at least one CPAP weaning attempt (\>0) is reported between Day 1 (first IMP intake) and Day 28 (Day 1 + 27 days). The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. By Hospital Discharge: An event is recorded as "Yes" if at least one CPAP weaning attempt (\>0) is reported between Day 1 and hospital discharge. The event is "No" if all available assessments during this period are present and equal to 0; otherwise, the event is missing. Hospital discharge date is obtained from EOS or, if missing, from the Hospital Discharge visit date; if unavailable, hospitalization is assumed ongoing.
| Percentage of Participants | Reparixin | Placebo |
|---|---|---|
| Day 28 | 40.0 | 65.4 |
| At Hospital Discharge (Up to Day 30) | 40.0 | 65.4 |
Intensive Care Unit (ICU) free days were defined as number of calendar days from first IMP intake during which a participant was alive and not hospitalized in an ICU. ICU-free days at Day 28 were calculated as 28 minus total number of ICU days up to Day 28, with negative values set to 0. Participants who died on or before Day 28 were assigned 0 ICU-free days. If a participant was discharged before Day 28 and died after discharge but before Day 28, ICU-free days at Day 28 equaled ICU-free days at discharge. Endpoint was set to missing if participant was alive but followed for fewer than 26 days or if required data were missing. ICU-free days at hospital discharge were calculated as (discharge date - first IMP intake date + 1) minus total ICU days up to discharge, with negative values set to 0. Participants who died during hospitalization were assigned 0 ICU-free days. If discharge did not occur and death occurred after Day 28, ICU-free days at discharge equaled ICU-free days at Day 28.
| Days | Reparixin | Placebo |
|---|---|---|
| Day 28 | 8.8 ± 9.19 | 8.0 ± 8.72 |
| At Hospital Discharge (Up to Day 30) | 4.5 ± 8.57 | 3.3 ± 6.38 |
Hospital-free days are a participant-centered metric defining the number of days a participant stays alive outside an acute-care hospital. If the participant was alive at Day 28 (last available day ≥26), hospital-free days were calculated as 28 minus total hospital days up to Day 28. If the participant died on or before Day 28, hospital-free days were set to 0.
| Days | Reparixin | Placebo |
|---|---|---|
| Hospital-free Days | 6.9 ± 8.46 | 6.2 ± 7.93 |
Percentage of participants who underwent a tracheostomy between Day 1 and Day 28 or hospital discharge, has been presented. The event is recorded as "Yes" if a tracheostomy occurred during this period, "No" if no procedure occurred and the visit/discharge date is available and missing if both the procedure date and visit/discharge date are unavailable.
| Percentage of Participants | Reparixin | Placebo |
|---|---|---|
| Day 28 | 26.3 | 10.5 |
| At Hospital Discharge (Up to Day 30) | 18.2 | 4.8 |
An LTAC is a Long Term Acute Care Hospital, a facility that specializes in the treatment of participants with serious medical conditions, including patients with ongoing needs for mechanical ventilation, but who no longer require intensive care or extensive diagnostic procedures. The participants in LTAC are transferred there directly from the intensive care unit because they require more care than they can receive in a rehabilitation center, skilled care facility or at home.
| Percentage of Participants | Reparixin | Placebo |
|---|---|---|
| At Day 28 | 15.8 | 10.5 |
| At Hospital Discharge (Up to Day 30) | 22.7 | 14.3 |
Percentage of death by Day 28 and Day 60 has been reported. The event is recorded as "Yes" if death occurred within the period, "No" if the participant was alive with last available assessment at or beyond Day 28 or Day 60.
| Percentage of Participants | Reparixin | Placebo |
|---|---|---|
| Up to Day 28 | 34.4 | 32.3 |
| Up to Day 60 | 38.7 | 36.7 |
A participant was considered discharged alive by Day 28 if hospital discharge occurred on or before Day 28, regardless of vital status after discharge. Participants were considered not discharged alive by Day 28 if they died without a recorded discharge date, were discharged after Day 28, had a missing discharge date with sufficient follow-up (last available day ≥26), or had a discharge date equal to the date of death. The endpoint was set to missing if the discharge date was missing and the participant was alive but followed for fewer than 26 days. Percentage of participants discharged from hospital by Day 28 has been presented.
| Percentage of Participants | Reparixin | Placebo |
|---|---|---|
| Hospital Discharge by Day 28 | 52.9 | 48.4 |
Plasma biomarker levels for Interleukin -6 (IL-6), IL-8 and plasma Tumor Necrosis Factor Receptor 1 (TNFr-1) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
| picograms per milliliter (pg/mL) | Reparixin | Placebo |
|---|---|---|
| IL-6 at Day 3 | -374.8 ± 1131.21 | -288.9 ± 928.43 |
| IL-6 at Day 7 | -496.6 ± 1611.79 | -25.7 ± 1740.13 |
| IL-6 at Day 14 | -597.5 ± 1769.44 | -555.1 ± 1395.54 |
| IL-8 at Day 3 | -41.0 ± 182.38 | -50.2 ± 163.64 |
| Interleukin-8 at Day 7 | -72.6 ± 261.58 | 273.3 ± 1624.38 |
| IL-8 at Day 14 | -119.1 ± 297.84 | -48.0 ± 138.43 |
| Plasma TNFr-1 at Day 3 | -104.7 ± 2425.49 | -414.4 ± 2713.97 |
| Plasma TNFr-1 at Day 7 | 1037.6 ± 4822.63 | 242.4 ± 4481.16 |
| Plasma TNFr-1 at Day 14 | -816.4 ± 1936.29 | 1630.6 ± 8635.55 |
Plasma biomarker levels of plasminogen activator inhibitor-1 (PAI-1), intercellular adhesion molecule-1 (ICAM-1), and receptor for advanced glycation end products (RAGE) were measured using validated laboratory methods. Baseline was defined as the last measurement collected prior to IMP intake, regardless of the visit at which it was obtained. Change from baseline was calculated as the post-baseline plasma concentration minus the baseline concentration.
| nanograms per milliliter (ng/mL) | Reparixin | Placebo |
|---|---|---|
| PAI-1 at Day 3 | -72.2 ± 135.17 | -23.7 ± 176.23 |
| PAI-1 at Day 7 | -50.8 ± 152.43 | -13.8 ± 316.01 |
| PAI-1 at Day 14 | -54.7 ± 140.19 | -27.6 ± 274.36 |
| ICAM-1 at Day 3 | -27.80 ± 134.695 | 7.79 ± 202.032 |
| ICAM-1 at Day 7 | -52.71 ± 107.506 | 23.83 ± 335.413 |
| ICAM-1 at Day 14 | -111.57 ± 229.153 | 59.00 ± 396.787 |
| RAGE at Day 3 | -5.3027 ± 11.74930 | -7.1846 ± 12.21701 |
| RAGE at Day 7 | -9.4912 ± 19.20777 | -10.6129 ± 16.50211 |
| RAGE at Day 14 | -11.3136 ± 22.22486 | -13.6609 ± 18.04041 |
An Adverse Event (AE) is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention. A TEAE is defined as any untoward medical occurrence that begins or worsens in intensity or frequency after the initiation of a treatment (e.g., drug, device, or procedure) in a clinical study. A Serious TEAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization.
| Participants | Reparixin | Placebo |
|---|---|---|
| All TEAEs | 30 | 30 |
| All Serious TEAEs | 20 | 17 |
Collected over Up to 26 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reparixin | 12/35 (34.3%) | 20/35 (57.1%) | 30/35 (85.7%) |
| Placebo | 11/31 (35.5%) | 17/31 (54.8%) | 30/31 (96.8%) |
| Event | Reparixin | Placebo |
|---|---|---|
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 5/35 | 2/31 |
| Acute kidney injuryRenal and urinary disorders | 5/35 | 4/31 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/35 | 4/31 |
| Multiple organ dysfunction syndromeGeneral disorders | 4/35 | 4/31 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/35 | 3/31 |
| PneumoniaInfections and infestations | 2/35 | 2/31 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/35 | 0/31 |
| HypotensionVascular disorders | 2/35 | 0/31 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/35 | 1/31 |
| PneumomediastinumRespiratory, thoracic and mediastinal disorders | 0/35 | 1/31 |
| Event | Reparixin | Placebo |
|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 6/35 | 8/31 |
| AnaemiaBlood and lymphatic system disorders | 6/35 | 7/31 |
| HypertransaminasaemiaHepatobiliary disorders | 6/35 | 7/31 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/35 | 5/31 |
| HypertensionVascular disorders | 4/35 | 5/31 |
| HypotensionVascular disorders | 2/35 | 5/31 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 5/35 | 2/31 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/35 | 1/31 |
| Multiple organ dysfunction syndromeGeneral disorders | 4/35 | 4/31 |
| PyrexiaGeneral disorders | 3/35 | 4/31 |
Randomized Population comprised of all enrolled participants in the enrolled set (ENR) who were randomized to the study, regardless of whether they received the investigational medicinal product (IMP) or not.
| Age, Continuous(Years) | Reparixin | Placebo | Total |
|---|---|---|---|
| Mean | 52.5 ± 18.64 | 55.5 ± 12.38 | 53.9 ± 15.96 |
| Sex: Female, Male(Participants) | Reparixin | Placebo | Total |
|---|---|---|---|
| Female | 17 | 13 | 30 |
| Male | 18 | 18 | 36 |
| Race/Ethnicity, Customized(Participants) | Reparixin | Placebo | Total |
|---|---|---|---|
| Race/Ethnicity — White | 23 | 22 | 45 |
| Race/Ethnicity — Black or African American | 6 | 4 | 10 |
| Race/Ethnicity — White - Hispanic/Latino | 4 | 2 | 6 |
| Race/Ethnicity — Hispanic/Latino | 1 | 3 | 4 |
| Race/Ethnicity — Other | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2022 to primary completion in Mar 2025, 27 months.
Results were first posted in May 2026, 1 year 1 month after primary completion.
Of 59 phase 2 interventional studies under Respiratory Distress Syndrome, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 27 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Reparixin
Respiratory Distress Syndrome →