No Efficacy of the Combination of Lopinavir/Ritonavir Plus Hydroxychloroquine Versus Standard of Care in Patients Hospitalized With COVID-19: A Non-Randomized Comparison
| Autor: | Pierluca Piselli, Andrea Mariano, Chiara Agrati, Emanuele Nicastri, Roberta Gagliardini, Valentina Mazzotta, Andrea Antinori, Fabrizio Palmieri, Nicola Petrosillo, Alessandra Amendola, Francesco Vaia, Maria Rosaria Capobianchi, Amina Abdeddaim, Alessandra Vergori, Alessandro Cozzi-Lepri, Giuseppe Ippolito, Francesco Di Gennaro, Fabrizio Taglietti, Enrico Girardi, Luisa Marchioni, Giampiero D'Offizi |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
viral shedding Lopinavir/ritonavir RM1-950 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine antivirals Randomized controlled trial law invasive ventilation Internal medicine medicine Clinical endpoint Pharmacology (medical) 030212 general & internal medicine Original Research Pharmacology drug repurposing business.industry Proportional hazards model SARS-CoV-2 Hydroxychloroquine Lopinavir Breathing Ritonavir Therapeutics. Pharmacology business medicine.drug |
| Zdroj: | Frontiers in Pharmacology Frontiers in Pharmacology, Vol 12 (2021) |
| ISSN: | 1663-9812 |
| Popis: | Objectives: No specific treatment has been approved for COVID-19. Lopinavir/ritonavir (LPV/r) and hydroxychloroquine (HCQ) have been used with poor results, and a trial showed advantages of combined antiviral therapy vs. single antivirals. The aim of the study was to assess the effectiveness of the combination of antivirals (LPV/r and HCQ) or their single use in COVID-19 hospitalized patients vs. standard of care (SoC).Methods: Patients ≥18 years with SARS-CoV-2 infection, defined as positive RT-PCR from nasal/oropharyngeal (NP/OP) swab or positive serology, admitted at L. Spallanzani Institute (Italy) were included.Primary endpoint: time to invasive ventilation/death. Secondary endpoint: time to two consecutive negative SARS-CoV-2 PCRs in NP/OP swabs. In order to control for measured confounders, a marginal Cox regression model with inverse probability weights was used.Results: A total of 590 patients were included in the analysis: 36.3% female, 64 years (IQR 51–76), and 91% with pneumonia. Cumulative probability of invasive ventilation/death at 14 days was 21.2% (95% CI 17.6, 24.7), without difference between SOC, LPV/r, hydroxychloroquine, HCQ + LPV/r, and SoC. The risk of invasive ventilation/death in the groups appeared to vary by baseline ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2). Overall cumulative probability of confirmed negative nasopharyngeal swabs at 14 days was 44.4% (95% CI 38.9, 49.9), without difference between groups.Conclusion: In this retrospective analysis, we found no difference in the rate of invasive ventilation/death or viral shedding by different strategies, as in randomized trials performed to date. Moreover, even the combination HCQ + LPV/r did not show advantages vs. SoC. |
| Databáze: | OpenAIRE |
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