Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04878055
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Viral Drug: Reparixin Other: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: subjects will be randomized with a 2:1 randomization ratio
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 14, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Reparixin
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
Drug: Reparixin
2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).
Other Name: DF 1681Y

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




Primary Outcome Measures :
  1. Proportion of patients alive and free of respiratory failure at Day 28 [ Time Frame: At day 28 ]

Secondary Outcome Measures :
  1. Proportion of patients alive and free of respiratory failure at day 60 [ Time Frame: At day 60 ]
  2. Mortality rates up to Day 28 [ Time Frame: Up to Day 28 ]
  3. Incidence of ICU admission until Day 28 [ Time Frame: Until day 28 ]
  4. 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 ]
  5. 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) ]
  6. Incidence of Adverse Events (AEs) [ Time Frame: From randomization till the last follow-up, up to 90 days. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878055


Contacts
Layout table for location contacts
Contact: Maria De Pizzol, BSc, PhD +39 02 583831 clinops@pec.dompe.it
Contact: Giovanna Di Turi, BSc +39 02 583831 clinops@pec.dompe.it

Locations
Show Show 17 study locations
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
Investigators
Layout table for investigator information
Principal Investigator: Giovanni Landoni, MD IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione
Layout table for additonal information
Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT04878055    
Other Study ID Numbers: REP0220
2020-005919-51 ( EudraCT Number )
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021

Layout table for additional information
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
Keywords provided by Dompé Farmaceutici S.p.A:
Covid-19
SARS-CoV-2
Pneumonia
Severe pneumonia
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases