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

Primary Purpose

Pneumonia, Viral

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Reparixin
Placebo
Sponsored by
Dompé Farmaceutici S.p.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Viral focused on measuring Covid-19, SARS-CoV-2, Pneumonia, Severe pneumonia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 to 90, male and female subject of any race
  2. Reverse transcriptase Polymerase Chain Reaction (rt-PCR)-confirmed COVID-19 infection based on a nasal / oropharyngeal swab within 10 days before randomization

  3. At least one of the following: 1) Respiratory distress with tachypnea (RR ≥ 24 breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2), P/F >100 and <300 mmHg (1mmHg = 0.133kPa), 3) SpO2 ≤ 94% while breathing ambient air.

    Calculation through validated Sat/FiO2 scales is allowed. P/F value of reference if the last available before the signature of consent.

  4. Need of supplemental oxygen (i.e. new use of supplemental oxygen, or increased oxygen requirement if on chronic oxygen) requiring low- or high-flow oxygen or non-invasive mechanical ventilation (7-point WHO-OS category 4 or 5).
  5. Radiological chest imaging (X-rays, CT scan) confirms lung involvement and inflammation.

Exclusion Criteria:

  1. Cannot obtain informed consent.
  2. Hepatic dysfunction with Child Pugh score B or C, or ALT or AST> 5 times the upper limit.
  3. Renal dysfunction with estimated glomerular filtration rate (MDRD) < 50 mL/min/1.73 m2 or patient receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
  4. Bacterial sepsis (besides COVID-19 sepsis).
  5. Known congenital or acquired immune deficiency.
  6. Positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women; women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study.

Sites / Locations

  • The George Washington University Medical Faculty Associates, 2150 Pennsylvania Avenue NW
  • Franciscan Alliance, 421 N Emerson Ave,
  • Policlinico S. Orsola Malpighi UO di Pneumologia e Terapia Int. Respiratoria
  • Ospedale Policlinico San Martino Malattie infettive e tropicali
  • Ospedale regionale San Salvatore U.O.C. Anestesia e Rianimazione
  • IRCCS Istituto Clinico Humanitas U.O. Medicina D'Urgenza
  • ASST Grande Ospedale Metropolitano Niguarda Dipartimento Malattie Infettive
  • IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione
  • ASST SANTI PAOLO E CARLO Ospedale San Paolo Struttura Complessa Malattie Infettive
  • ASST-Monza Ospedale San Gerardo Malattie Infettive
  • A.O.U. Federico II Malattie Infettive del Policlinico Federico II
  • Università della Campania "Luigi Vanvitelli" Dipartimento di Malattie Infettive
  • Policlinico Universitario Campus Bio-Medico UOC Anestesia e Rianimazione
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I, UOC Malattie Infettive
  • Università Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli" - Istituto di Clinica delle Malattie Infettive
  • ASST dei Sette Laghi Ospedale di Circolo e Fondazione Macchi Struttura Complessa Malattie infettive e tropicali
  • A.O.U. Integrata di Verona U.O. Medicina Respiratoria, sezione di Medicina Interna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reparixin

Placebo

Arm Description

Reparixin oral tablets, 1200 mg three times daily (TID) (2 tablets 600 mg each, TID) for up to 21 days or until decision of discharge from the hospital, on top of standard supportive care

placebo, 2 tablets TID (identical to Reparixin tablets) for up to 21 days or until decision of discharge from the hospital, on top of standard supportive care.

Outcomes

Primary Outcome Measures

Proportion of patients alive and free of respiratory failure at Day 28

Secondary Outcome Measures

Proportion of patients alive and free of respiratory failure at day 60
Mortality rates up to Day 28
Incidence of ICU admission until Day 28
Time to recovery (category 1 - 2 - 3 of the 7-point WHO Ordinal Scale of clinical improvement (WHO-OS)) until Day 28
Proportion of patients alive and free of respiratory failure at fixed time-points
Incidence of Adverse Events (AEs)

Full Information

First Posted
April 30, 2021
Last Updated
January 14, 2022
Sponsor
Dompé Farmaceutici S.p.A
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1. Study Identification

Unique Protocol Identification Number
NCT04878055
Brief Title
Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dompé Farmaceutici S.p.A

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Viral
Keywords
Covid-19, SARS-CoV-2, Pneumonia, Severe pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
subjects will be randomized with a 2:1 randomization ratio
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reparixin
Arm Type
Experimental
Arm Description
Reparixin oral tablets, 1200 mg three times daily (TID) (2 tablets 600 mg each, TID) for up to 21 days or until decision of discharge from the hospital, on top of standard supportive care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, 2 tablets TID (identical to Reparixin tablets) for up to 21 days or until decision of discharge from the hospital, on top of standard supportive care.
Intervention Type
Drug
Intervention Name(s)
Reparixin
Other Intervention Name(s)
DF 1681Y
Intervention Description
2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matched placebo, i.e. 2 tablets for the total of three daily administrations (6 tablets daily).
Primary Outcome Measure Information:
Title
Proportion of patients alive and free of respiratory failure at Day 28
Time Frame
At day 28
Secondary Outcome Measure Information:
Title
Proportion of patients alive and free of respiratory failure at day 60
Time Frame
At day 60
Title
Mortality rates up to Day 28
Time Frame
Up to Day 28
Title
Incidence of ICU admission until Day 28
Time Frame
Until day 28
Title
Time to recovery (category 1 - 2 - 3 of the 7-point WHO Ordinal Scale of clinical improvement (WHO-OS)) until Day 28
Time Frame
Until Day 28
Title
Proportion of patients alive and free of respiratory failure at fixed time-points
Time Frame
At Days 3, 7(±1),14(±2), 21(±2), 28 (±2), 60(±2) after randomization (randomization = day 1)
Title
Incidence of Adverse Events (AEs)
Time Frame
From randomization till the last follow-up, up to 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 90, male and female subject of any race Reverse transcriptase Polymerase Chain Reaction (rt-PCR)-confirmed COVID-19 infection based on a nasal / oropharyngeal swab within 10 days before randomization At least one of the following: 1) Respiratory distress with tachypnea (RR ≥ 24 breaths/min without oxygen); 2) Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2), P/F >100 and <300 mmHg (1mmHg = 0.133kPa), 3) SpO2 ≤ 94% while breathing ambient air. Calculation through validated Sat/FiO2 scales is allowed. P/F value of reference if the last available before the signature of consent. Need of supplemental oxygen (i.e. new use of supplemental oxygen, or increased oxygen requirement if on chronic oxygen) requiring low- or high-flow oxygen or non-invasive mechanical ventilation (7-point WHO-OS category 4 or 5). Radiological chest imaging (X-rays, CT scan) confirms lung involvement and inflammation. Exclusion Criteria: Cannot obtain informed consent. Hepatic dysfunction with Child Pugh score B or C, or ALT or AST> 5 times the upper limit. Renal dysfunction with estimated glomerular filtration rate (MDRD) < 50 mL/min/1.73 m2 or patient receiving continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. Bacterial sepsis (besides COVID-19 sepsis). Known congenital or acquired immune deficiency. Positive or missing pregnancy test before first drug intake or day 1; pregnant or lactating women; women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Landoni, MD
Organizational Affiliation
IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione
Official's Role
Principal Investigator
Facility Information:
Facility Name
The George Washington University Medical Faculty Associates, 2150 Pennsylvania Avenue NW
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Franciscan Alliance, 421 N Emerson Ave,
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Policlinico S. Orsola Malpighi UO di Pneumologia e Terapia Int. Respiratoria
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Policlinico San Martino Malattie infettive e tropicali
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale regionale San Salvatore U.O.C. Anestesia e Rianimazione
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas U.O. Medicina D'Urgenza
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda Dipartimento Malattie Infettive
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione
City
MIlan
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST SANTI PAOLO E CARLO Ospedale San Paolo Struttura Complessa Malattie Infettive
City
Milan
ZIP/Postal Code
20142
Country
Italy
Facility Name
ASST-Monza Ospedale San Gerardo Malattie Infettive
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
A.O.U. Federico II Malattie Infettive del Policlinico Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università della Campania "Luigi Vanvitelli" Dipartimento di Malattie Infettive
City
Napoli
ZIP/Postal Code
80133
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico UOC Anestesia e Rianimazione
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I, UOC Malattie Infettive
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli" - Istituto di Clinica delle Malattie Infettive
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
ASST dei Sette Laghi Ospedale di Circolo e Fondazione Macchi Struttura Complessa Malattie infettive e tropicali
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
A.O.U. Integrata di Verona U.O. Medicina Respiratoria, sezione di Medicina Interna
City
Verona
ZIP/Postal Code
37124
Country
Italy

12. IPD Sharing Statement

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

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