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Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.

NCT04878055 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2024-06-13

Study results available
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Summary

The study objective is to assess Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.

Conditions

  • Pneumonia, Viral

Interventions

DRUG

Reparixin

2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).

OTHER

Placebo

Matched placebo, i.e. 2 tablets for the total of three daily administrations (6 tablets daily).

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Giovanni Landoni, MD, PhD · Ospedale San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-14
Primary Completion
2021-09-30
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States
  • Italy

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 NCT04878055 on ClinicalTrials.gov