NCT04878055

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

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 3 clinical trial designed as a randomized, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of Reparixin in hospitalized adult patients with severe COVID-19 pneumonia. Patients will be screened for the participation in the study and eventually randomized based on an unbalanced randomization scheme (2:1) to Reparixin oral tablets (2 x 600 mg TID) for up to 21 days or to placebo. An unequal randomization is justified by the need to gain experience and more safety data with the investigated treatment and by an expected better acceptability of the trial by patients. The placebo control arm is justified by the unavailability of a well-defined standard of care for subjects with COVID-19 pneumonia who are candidates for this study. All patient will receive the standard supportive care based on the patient's clinical need. Follow-up information on the patient's clinical condition will be collected until day 90.

Conditions

• Pneumonia, Viral

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-02-14
• Primary completion: 2021-09-30
• Completion: 2021-10-31
• First posted: 2021-05-07
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

17 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated drug study