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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pneumonia, Viral

In brief

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.

Key facts

Study ID

NCT04878055

Run by

Dompé Farmaceutici S.p.A

People needed

287

Starts

2021-02-14

Expected to finish

2021-10-31

Last updated by the study team

2024-06-13

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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