Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
NCT ID: NCT04878055
Last Updated: 2024-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
287 participants
INTERVENTIONAL
2021-02-14
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Reparixin
2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).
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.
Placebo
Matched placebo, i.e. 2 tablets for the total of three daily administrations (6 tablets daily).
Interventions
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Reparixin
2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).
Placebo
Matched placebo, i.e. 2 tablets for the total of three daily administrations (6 tablets daily).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
No
Sponsors
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Dompé Farmaceutici S.p.A
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni Landoni, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Raffaele
Locations
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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
Napoli, , Italy
Università della Campania "Luigi Vanvitelli" Dipartimento di Malattie Infettive
Napoli, , 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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-005919-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REP0220
Identifier Type: -
Identifier Source: org_study_id
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