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

NCT04878055 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: REP02202020-005919-51
• Study Type: interventional
• Target: 287
• Locations: 2 countries
• Sites: 17

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.

Conditions

Pneumonia, Viral

Keywords

Covid-19; SARS-CoV-2; Pneumonia; Severe pneumonia

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Alive and Free of Respiratory Failure at Day 28

  The event variable is defined as "the proportion of patients alive and free of respiratory failure at Day 28". This means no need of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) or admission to intensive care unit (ICU) linked to worsening of respiratory parameters compared to baseline.

  At day 28

Secondary Outcomes (26)

• Proportion of Patients Alive and Free of Respiratory Failure at Day 60

  At day 60

• Mortality Rates up to Day 28

  Up to Day 28

• Incidence of ICU Admission Until Day 28

  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

  Until Day 28

• Proportion of Patients Alive and Free of Respiratory Failure at Fixed Timepoints

  At Days 3, 7(±1),14(±2), 21(±2) and 90(±2) after randomization (randomization = day 1)

Study Arms (2)

Reparixin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Reparixin DRUG

2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).

Also known as: DF 1681Y

Reparixin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

Study Sites (17)

The George Washington University Medical Faculty Associates, 2150 Pennsylvania Avenue NW

Washington D.C., District of Columbia, 20037, United States

Location

Franciscan Alliance, 421 N Emerson Ave,

Greenwood, Indiana, 46143, United States

Location

Policlinico S. Orsola Malpighi UO di Pneumologia e Terapia Int. Respiratoria

Bologna, 40138, Italy

Location

Ospedale Policlinico San Martino Malattie infettive e tropicali

Genova, 16132, Italy

Location

Ospedale regionale San Salvatore U.O.C. Anestesia e Rianimazione

L’Aquila, 67100, Italy

Location

IRCCS Ospedale San Raffaele Centro di Ricerca Anestesia e Rianimazione

Milan, 20132, Italy

Location

ASST SANTI PAOLO E CARLO Ospedale San Paolo Struttura Complessa Malattie Infettive

Milan, 20142, Italy

Location

IRCCS Istituto Clinico Humanitas U.O. Medicina D'Urgenza

Milan, 20089, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda Dipartimento Malattie Infettive

Milan, 20162, Italy

Location

ASST-Monza Ospedale San Gerardo Malattie Infettive

Monza, 20900, Italy

Location

A.O.U. Federico II Malattie Infettive del Policlinico Federico II

Napoli, 80131, Italy

Location

Università della Campania "Luigi Vanvitelli" Dipartimento di Malattie Infettive

Napoli, 80133, Italy

Location

Policlinico Universitario Campus Bio-Medico UOC Anestesia e Rianimazione

Roma, 00128, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I, UOC Malattie Infettive

Roma, 00161, Italy

Location

Università Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli" - Istituto di Clinica delle Malattie Infettive

Roma, 00168, Italy

Location

ASST dei Sette Laghi Ospedale di Circolo e Fondazione Macchi Struttura Complessa Malattie infettive e tropicali

Varese, 21100, Italy

Location

A.O.U. Integrata di Verona U.O. Medicina Respiratoria, sezione di Medicina Interna

Verona, 37124, Italy

Location

Related Publications (1)

• Piemonti L, Landoni G, Voza A, Puoti M, Gentile I, Coppola N, Nava S, Mattei A, Marinangeli F, Marchetti G, Bonfanti P, Mastroianni CM, Bassetti M, Crisafulli E, Grossi PA, Zangrillo A, Desai A, Merli M, Foggia M, Carpano M, Schiavoni L, D'Arminio Monforte A, Bisi L, Russo G, Busti F, Rovelli C, Perrotta E, Goisis G, Gavioli EM, Toya S, De Pizzol M, Mantelli F, Allegretti M, Minnella EM. Efficacy and Safety of Reparixin in Patients with Severe COVID-19 Pneumonia: A Phase 3, Randomized, Double-Blind Placebo-Controlled Study. Infect Dis Ther. 2023 Oct;12(10):2437-2456. doi: 10.1007/s40121-023-00871-5. Epub 2023 Oct 5.

  PMID: 37798468 DERIVED

MeSH Terms

Conditions

Pneumonia, Viral; COVID-19; Pneumonia

Interventions

reparixin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Results Point of Contact

• Title: Clinical Development & Operations
• Organization: Dompé Farmaceutici SpA

clinical.trials@dompe.com

+39 02 583831

Study Officials

• Giovanni Landoni, MD, PhD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: subjects will be randomized with a 2:1 randomization ratio

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 7, 2021
• Study Start: February 14, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 31, 2021
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-05

Locations

IT (15); US (2)