Abstract
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.
Highlights
In December 2019, an outbreak of viral pneumonia cases of unknown cause was identified in Wuhan, China
A total of 590 patients with diagnosis of COVID-19 were included in this analysis: 36.3% female, median age of 64 years (IQR 51–76), 91% with a diagnosis of pneumonia, median baseline PaO2/FiO2 of 324 (IQR 244–398) mmHg, days from onset of symptoms to hospitalization were 9 (IQR 5–12), and 17.8% with 2 or more comorbidities
We report a retrospective study with real-world data collected from routine care to assess the clinical and virological efficacy of hydroxychloroquine, lopinavir/ritonavir, or the combination of hydroxychloroquine plus lopinavir/ ritonavir vs. standard of care (SoC) in a population of 590 patients admitted to our hospital for COVID-19 infection
Summary
In December 2019, an outbreak of viral pneumonia cases of unknown cause was identified in Wuhan, China. A novel coronavirus was quickly identified in some of these patients and it has been designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (European Centre for Disease Prevention and Control, 2020). There are no approved therapeutic agents available for SARS-CoV-2, and great efforts have been unfolded for the discovery of possible treatment strategies. Many repurposed drugs have shown some preclinical activity against SARS-CoV-2 and have been experimented in vivo (Tobaiqy et al, 2020). Prompt identification and implementation of life support therapies are pivotal steps in order to prevent the spreading of the infection and improve patient’s clinical outcome. Some data about treatment from observational studies, compassionate use programs, and few RCT results are available up-to-date
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