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Reparixin + Standard of care for Acute Respiratory Distress Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Florida Health Jacksonville, Jacksonville, FLAcute Respiratory Distress SyndromeReparixin 600mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will evaluate the effectiveness of a drug to improve lung injury & inflammation and help patients recover from ARDS. It will also assess the drug's safety.

Eligible Conditions
  • Acute Respiratory Distress Syndrome (ARDS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
MultiStem
1
Subcutaneous Heparin
1
Reparixin

Study Objectives

2 Primary · 34 Secondary · Reporting Duration: to day 3(±8h), 7±1 day, 14±2 day, 21±2 day, 28±2 day

Day 2
Acute lung injury score [composite of PaO2/FIO2 ratio, PEEP, lung compliance (plateau airway pressure minus PEEP/TV) and extent of pulmonary infiltrates] at 2(±8h) day, 3(±8h) day, 7±1 day, 14±2 day (if still intubated)
Chest X-Rays assessment of pulmonary edema by "radiographic assessment of lung edema" (RALE) score at 2(±8h), 3(±8h), 7±1, 14±2 days
Sequential Organ Failure Assessment (SOFA) score at 2(±8h) day, 3(±8h) day, 7±1 day, 14±2 day (if still intubated)
Ventilatory ratio (product of minute ventilation and PaCO2) at 2(±8h) day, 3(±8h) day, 7±1 day, 14±2 day (if still intubated)
Day 14
Intubation (procedure)
Edema
Intubation (procedure)
Intubation (procedure)
at day 28
Ventilator - respiratory equipment
by day 14
Incidence of Extracorporeal Membrane Oxygenation (ECMO) by day 14
Use of vasoactive medications by day 14
by day 14±2
Incidence of Extracorporeal Membrane Oxygenation (ECMO) by day 14±2
Use of vasoactive medications by day 14±2
by day 28
All-cause mortality by day 28
Hospital-free days by day 28 and at hospital discharge
Incidence of tracheostomies by day 28 and at hospital discharge
Incidence of transfer to long term acute care (LTAC) facility by day 28 and at hospital discharge
Intensive Care Unit free days by day 28 and at hospital discharge
Percentage of patients achieving pressure support ventilation equal to 5 cmH20 with PEEP equal to 5 cmH20 for 2 hours (measure of weaning) by day 28 and at hospital discharge
by day 28±2
All-cause mortality by day 28±2
Hospital-free days by day 28±2
Communicable Diseases
Incidence of tracheostomies by day 28±2
Incidence of transfer to long term acute care (LTAC) facility by day 28±2
Intensive Care Unit free days by day 28±2
Percentage of patients achieving pressure support ventilation equal to 5 cm H20 with PEEP equal to 5 cm H20 for 2 hours (measure of weaning) by day 28±2
by day 60
All-cause mortality by day 60
Day 14
Plasma levels (free and bound) of DF1681Y (acidic form of reparixin) and relevant metabolites (DF2188Y, DF2243Y, and ibuprofen (DF1674Y))
Plasma levels (free and bound) of DF2156Y (acidic form of reparixin) and relevant metabolites (DF2108Y, S-isomer; DF2227Y, R-isomer)
from the date of First Patient First Visit (FPFV) to the date of Last Patient Last Visit (LPLV)
Incidence of Treatment Emergent AEs (TEAEs) and SAEs (TESAEs) from the beginning of study treatment to up to the end of study participation.
Day 3
eGFR, absolute value and change from screening to day 3(±8h), day 7±1, day 14±2, day 21±2 (if still receiving reparixin), day 28±2
Day 3
Interleukin-1
Day 14
Change from baseline to day 3, 7 and 14 days in plasma levels of IL-6, IL-8, PAI-1, TNFr-1, ICAM-1 RAGE
to day 4
Change in oxigenation index (OI) from baseline to day 4
to day 4±1
Change in oxigenation index (OI) from baseline to day 4±1
to day 7
Change in oxygenation index (OI) from baseline to day 7 of treatment

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
MultiStem
2
Subcutaneous Heparin
2
Reparixin

Trial Design

2 Treatment Groups

Reparixin + Standard of care
1 of 2
Placebo + Standard of care
1 of 2

Experimental Treatment

Non-Treatment Group

66 Total Participants · 2 Treatment Groups

Primary Treatment: Reparixin + Standard of care · Has Placebo Group · Phase 2

Reparixin + Standard of care
Drug
Experimental Group · 1 Intervention: Reparixin 600mg · Intervention Types: Drug
Placebo + Standard of care
Other
PlaceboComparator Group · 1 Intervention: Matching Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: to day 3(±8h), 7±1 day, 14±2 day, 21±2 day, 28±2 day

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
47 Previous Clinical Trials
4,242 Total Patients Enrolled
Enrico Minnella, MDStudy DirectorDompè farmaceutici SpA
1 Previous Clinical Trials
526 Total Patients Enrolled
Francesco Sergio, MD-PhDStudy DirectorDompè farmaceutici SpA

Eligibility Criteria

Age 18+ · All Participants · 19 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must not consume any substances such as drugs or alcohol during the study.
You are allergic to ibuprofen.
You have developed symptoms of ARDS in the past 48 hours.
You must have a partner who is sexually abstinent or practices safe sex measures during the trial.
You have difficulty breathing and it is not caused by heart problems or excess fluid in your body. If you have a sudden worsening of heart failure, it needs to be treated before you can join the study.
References

Frequently Asked Questions

Are recruitments still taking place for this clinical experiment?

"Indeed, clinicaltrials.gov provides evidence that this investigation is actively sourcing possible participants. This trial was initially introduced on February 7th 2023 and most recently modified on the 24th of the same month. 66 people are required to be recruited from 30 distinct medical facilities for completion." - Anonymous Online Contributor

Unverified Answer

Does the FDA sanction the use of Reparixin in combination with accepted medical practices?

"A score of 2 was given to Reparixin + Standard of care as there is evidence for its safety, yet no documentation has been found proving the efficacy." - Anonymous Online Contributor

Unverified Answer

What is the uppermost number of participants in this investigation?

"This medical study necessitates 66 eligible candidates. Different locations, such as Banner - University Medical Center Phoenix in Phoenix and University of Southern California in Los Angeles, are providing patients with the opportunity to take part." - Anonymous Online Contributor

Unverified Answer

How widespread is the implementation of this trial?

"Banner - University Medical Center Phoenix in Phoenix, Arizona, the University of Southern California in Los Angeles, and the University of California Irvine Health in Orange are three primary sites for this medical trial. Additionally, there are 30 other places around the United States involved with the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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