Clinical Trials Logo
  1. Home
  2. Severe Pneumonia
  3. NCT04794803

Reparixin in COVID-19 Pneumonia - Efficacy and Safety

Severe Pneumonia Clinical Trial

Official title:
Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With COVID-19 Pneumonia

Clinical Trial Summary

- Phase 2 Study Objectives: efficacy and safety of of Reparixin treatment as compared to the control arm in adult patients with severe COVID-19 pneumonia - Phase 3 Study Objectives: efficacy and safety of Reparixin treatment as compared to the control arm in adult patients with moderate or severe COVID-19 pneumonia

Clinical Trial Description

This clinical trial is an adaptive phase 2/3, randomized, controlled multicenter study on the efficacy and safety of Reparixin in the treatment of hospitalized patients with COVID-19 pneumonia. 48 patients are planned to be enrolled in Phase 2 and an estimated total of 111 patients are planned to be enrolled up to the end of Phase 3, with a randomization 2:1 Reparixin vs Control (Standard of care). In the phase 2 segment of this study, patients are randomized 2:1 to Reparixin oral tablets 1200 mg (Group 1, active treatment) or standard of care (Group 2, control arm). In case of worsening (e.g. need of ICU and/or mechanical ventilation) after the first 24hrs, patients are offered a rescue medication with no restriction from the sponsor and fully based on their physicians' judgement. In the phase 3 segment of this study, it is planned that patients are randomized 2:1 to Reparixin or standard of care. The Phase 3 design will be reassessed and decided based on the results of the Phase 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04794803
Study type Interventional
Source Dompé Farmaceutici S.p.A
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date May 5, 2020
Completion date February 2, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06114784 - Microbiome and Host Susceptibility in Severe Pneumonia, a Prospective, Multicenter, Cohort Study
Completed NCT03870243 - Feasibility and Acceptability Followed by Effectiveness of bCPAP for Treatment of Children Aged 1-59 Months With Severe Pneumonia in Ethiopia N/A
Completed NCT05158842 - Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study N/A
Suspended NCT04310865 - Yinhu Qingwen Granula for the Treatment of Severe CoVID-19 Phase 2/Phase 3
Completed NCT04457505 - One Year Follow-ups of Patients Admitted to Spanish Intensive Care Units Due to COVID-19
Recruiting NCT01068990 - Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients
Completed NCT03831906 - Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia) N/A
Recruiting NCT05768204 - Research on the Treatment of Severe Community-acquired Pneumonia in Children Phase 4
Recruiting NCT04359667 - Serum IL-6 and Soluble IL-6 Receptor in Severe COVID-19 Pneumonia Treated With Tocilizumab
Not yet recruiting NCT04395066 - Molecular Diagnosis and Prognosis of Severe Pulmonary Infection Immunosuppressed Hosts
Not yet recruiting NCT05143593 - Species-specific Bacterial Detector for Fast Pathogen Diagnosis of Severe Pneumonia N/A
Completed NCT05663905 - Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients Phase 4
Not yet recruiting NCT04282928 - Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells for the Treatment of Severe Viral Pneumonian Phase 1
Completed NCT01192789 - Community Case Management of the Severe Pneumonia With Oral Amoxicillin in Children 2-59 Months of Age N/A
Completed NCT00455468 - Randomized Controlled Trial (RCT) in Children With Severe Pneumonia N/A
Completed NCT03588377 - Impact of Pulse Oximetry on Hospital Referral Acceptance in Children Under 5 With Severe Pneumonia N/A
Recruiting NCT04955756 - Early Identification and Severity Prediction of Acute Respiratory Infectious Disease N/A
Recruiting NCT04882436 - Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia
Not yet recruiting NCT03891212 - The Effect of Prone Position Drainage on the Efficacy of Severe Pneumonia，a Multicenter Randomized Controlled Trial N/A