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Deprecated: Implicit conversion from float 397.59999999999997 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Front+Pharmacol 2020 ; 11 (ä): 1071 Nephropedia Template TP
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No Statistically Apparent Difference in Antiviral Effectiveness Observed Among Ribavirin Plus Interferon-Alpha, Lopinavir/Ritonavir Plus Interferon-Alpha, and Ribavirin Plus Lopinavir/Ritonavir Plus Interferon-Alpha in Patients With Mild to Moderate Coronavirus Disease 2019: Results of a Randomized, Open-Labeled Prospective Study #MMPMID32765274
Huang YQ; Tang SQ; Xu XL; Zeng YM; He XQ; Li Y; Harypursat V; Lu YQ; Wan Y; Zhang L; Sun QZ; Sun NN; Wang GX; Yang ZP; Chen YK
Front Pharmacol 2020[]; 11 (ä): 1071 PMID32765274show ga
BACKGROUND: Currently, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread globally, causing an unprecedented pandemic. However, there is no specific antiviral therapy for coronavirus disease 2019 (COVID-19). We conducted a clinical trial to compare the effectiveness of three antiviral treatment regimens in patients with mild to moderate COVID-19. METHODS: This was a single-center, randomized, open-labeled, prospective clinical trial. Eligible patients with mild to moderate COVID-19 were randomized into three groups: ribavirin (RBV) plus interferon-alpha (IFN-alpha), lopinavir/ritonavir (LPV/r) plus IFN-alpha, and RBV plus LPV/r plus IFN-alpha at a 1:1:1 ratio. Each patient was invited to participate in a 28-d follow-up after initiation of an antiviral regimen. The outcomes include the difference in median interval to SARS-CoV-2 nucleic acid negativity, the proportion of patients with SARS-CoV-2 nucleic acid negativity at day 14, the mortality at day 28, the proportion of patients re-classified as severe cases, and adverse events during the study period. RESULTS: In total, we enrolled 101 patients in this study. Baseline clinical and laboratory characteristics of patients were comparable among the three groups. In the analysis of intention-to-treat data, the median interval from baseline to SARS-CoV-2 nucleic acid negativity was 12 d in the LPV/r+IFN-alpha-treated group, as compared with 13 and 15 d in the RBV+IFN-alpha-treated group and in the RBV+LPV/r+ IFN-alpha-treated group, respectively (p=0.23). The proportion of patients with SARS-CoV-2 nucleic acid negativity in the LPV/r+IFN-alpha-treated group (61.1%) was higher than the RBV+ IFN-alpha-treated group (51.5%) and the RBV+LPV/r+IFN-alpha-treated group (46.9%) at day 14; however, the difference between these groups was calculated to be statistically insignificant. The RBV+LPV/r+IFN-alpha-treated group developed a significantly higher incidence of gastrointestinal adverse events than the LPV/r+ IFN-alpha-treated group and the RBV+ IFN-alpha-treated group. CONCLUSIONS: Our results indicate that there are no significant differences among the three regimens in terms of antiviral effectiveness in patients with mild to moderate COVID-19. Furthermore, the combination of RBV and LPV/r is associated with a significant increase in gastrointestinal adverse events, suggesting that RBV and LPV/r should not be co-administered to COVID-19 patients simultaneously. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov, ID: ChiCTR2000029387. Registered on January 28, 2019.