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Reparixin add-on Therapy to Standard Care to Limit Progression in Pts With COVID19 & Other Community Acquired Pneumonia

NCT05254990 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2026-02-24

Study results available
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Summary

Primary objective:

\- To compare the efficacy of reparixin vs. placebo in the proportion of patients dead or requiring IMV (or ECMO) by Day 28.

Key secondary objectives:

* To compare the efficacy of reparixin vs placebo in all-cause mortality at day 180.
* To compare the efficacy of reparixin vs placebo in proportion of patients alive and discharged at day 28
* To compare the efficacy of reparixin vs placebo in ventilatory-free days at day 28.
* To compare the efficacy of reparixin vs placebo in proportion of patients with IMV (or ECMO) by day 28.
* To compare the efficacy of reparixin vs placebo in length of primary hospital stay.

Other efficacy objectives

\- To compare the efficacy of reparixin vs placebo on several disease severity/progression measures including recovery, ventilatory free days and mortality.

Safety objectives:

\- To evaluate safety and tolerability of oral reparixin versus placebo in the specific clinical setting.

Conditions

  • Infectious Pneumonia
  • Severe COVID-19

Interventions

DRUG

Reparixin

Reparixin 600 mg tablets, administered orally at the dose of 1200 mg TID (2 tablets TID) as add-on therapy to standard of care up to 21 days. IMP was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that reparixin was taken with food. However, If the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

OTHER

Placebo

Administered orally three times a day (TID) as add-on therapy to standard of care (SoC) up to 21 days. Placebo was taken with a glass of water (about 250 mL) and a light meal or snack, as it was preferable that placebo was taken with food. However, if the patient was unwilling or unable to administer oral tablets, investigator could decide a nasogastric tube as an alternative route.

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Giovanni Landoni, MD · IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2024-07-29
Completion
2024-09-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Germany
  • Italy
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254990 on ClinicalTrials.gov