Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04878055
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2021-04-30
Brief Title:
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 21 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 patients clinical need Follow-up information on the patients clinical condition will be collected until day 90
Patients will be screened for the participation in the study and eventually randomized based on an unbalanced randomization scheme 21 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 patients clinical need Follow-up information on the patients clinical condition will be collected until day 90
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005919-51 | EUDRACT_NUMBER | None | None |