Abstract | INTRODUCTION: METHODS: This was a phase 2, open-label, multicenter, randomized study in hospitalized adult patients with severe COVID-19 pneumonia from May 5, 2020 until November 27, 2020. Patients were randomized 2:1 to receive 1200 mg reparixin orally three times daily or standard of care (SOC) for up to 21 days. The primary endpoint was defined as a composite of clinical events: use of supplemental oxygen, need for mechanical ventilation, intensive care unit admission, and/or use of rescue medication. RESULTS: Fifty-five patients were enrolled between reparixin (n = 36) and SOC (n = 19). The rate of clinical events was statistically significantly lower in the reparixin group compared with the SOC group (16.7% [95% CI 6.4-32.8%] vs. 42.1% [95% CI 20.3-66.5%], P = 0.02). The sensitivity analysis based on the Cox regression model provided an adjusted hazard ratio of 0.33 with statistical significance lower than 0.05 (95% CI 0.11-0.99; P = 0.047). Reparixin treatment appeared to be well tolerated. CONCLUSION: In patients with severe COVID-19, reparixin led to an improvement in clinical outcomes when compared with the SOC. A larger phase 3 clinical study is needed to confirm these results. TRIAL REGISTRATION: EudraCT identifier, 2020-001645-40; registered May 6, 2020 (retrospectively registered), and clinicaltrials.gov (NCT04794803) on March 8, 2021.
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Authors | Giovanni Landoni, Lorenzo Piemonti, Antonella d'Arminio Monforte, Paolo Grossi, Alberto Zangrillo, Enrico Bucci, Marcello Allegretti, Giovanni Goisis, Elizabeth M Gavioli, Neal Patel, Maria De Pizzol, Georgea Pasedis, Flavio Mantelli |
Journal | Infectious diseases and therapy
(Infect Dis Ther)
Vol. 11
Issue 4
Pg. 1559-1574
(Aug 2022)
ISSN: 2193-8229 [Print] New Zealand |
PMID | 35618953
(Publication Type: Journal Article)
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Copyright | © 2022. The Author(s). |