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0 0.5 1 1.5 2+ ICU admission -422% Improvement Relative Risk Recovery, day 14 11% Recovery, day 7 14% Viral clearance, day 14 -422% Viral clearance, day 7 -11% Lou et al. ChiCTR2000029544 Favipiravir RCT LATE Is late treatment with favipiravir beneficial for COVID-19? RCT 19 patients in China Higher ICU admission (p=0.21) and worse viral clearance (p=0.21), not stat. sig. Lou et al., European J. Pharmaceutical Sciences, doi:10.1016/j.ejps.2020.105631 Favors favipiravir Favors control
Clinical Outcomes and Plasma Concentrations of Baloxavir Marboxil and Favipiravir in COVID-19 Patients: An Exploratory Randomized, Controlled Trial
Lou et al., European Journal of Pharmaceutical Sciences, doi:10.1016/j.ejps.2020.105631, ChiCTR2000029544
Lou et al., Clinical Outcomes and Plasma Concentrations of Baloxavir Marboxil and Favipiravir in COVID-19 Patients: An.., European Journal of Pharmaceutical Sciences, doi:10.1016/j.ejps.2020.105631, ChiCTR2000029544
Oct 2020   Source   PDF  
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Small late stage RCT with 10 favipiravir, 10 baloxavir marboxil, and 10 control patients in China, showing no significant differences.
risk of ICU admission, 422.2% higher, RR 5.22, p = 0.21, treatment 2 of 9 (22.2%), control 0 of 10 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of no recovery, 11.1% lower, RR 0.89, p = 1.00, treatment 4 of 9 (44.4%), control 5 of 10 (50.0%), NNT 18, day 14.
risk of no recovery, 13.6% lower, RR 0.86, p = 0.58, treatment 7 of 9 (77.8%), control 9 of 10 (90.0%), NNT 8.2, day 7.
risk of no viral clearance, 422.2% higher, RR 5.22, p = 0.21, treatment 2 of 9 (22.2%), control 0 of 10 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 14.
risk of no viral clearance, 11.1% higher, RR 1.11, p = 1.00, treatment 5 of 9 (55.6%), control 5 of 10 (50.0%), day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lou et al., 25 Oct 2020, Randomized Controlled Trial, China, peer-reviewed, 13 authors, average treatment delay 8.5 days, trial ChiCTR2000029544.
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This PaperFavipiravirAll
Clinical Outcomes and Plasma Concentrations of Baloxavir Marboxil and Favipiravir in COVID-19 Patients: An Exploratory Randomized, Controlled Trial
Yan Lou, Lin Liu, Hangping Yao, Xingjiang Hu, Junwei Su, Kaijin Xu, Rui Luo, Xi Yang, Lingjuan He, Xiaoyang Lu, Qingwei Zhao, Tingbo Liang, Yunqing Qiu
European Journal of Pharmaceutical Sciences, doi:10.1016/j.ejps.2020.105631
Background: Effective antiviral drugs for COVID-19 are still lacking. This study aims to evaluate the clinical outcomes and plasma concentrations of baloxavir acid and favipiravir in COVID-19 patients. Methods: Favipiravir and baloxavir acid were evaluated for their antiviral activity against SARS-CoV-2 in vitro before the trial initiation. We conducted an exploratory trial with 3 arms involving hospitalized adult patients with COVID-19. Patients were randomized assigned in a 1:1:1 ratio into baloxavir marboxil group, favipiravir group, and control group. The primary outcome was the percentage of subjects with viral negative by Day 14 and the time from randomization to clinical improvement. Virus load reduction, blood drug concentration and clinical presentation were also observed. The trial was registered with Chinese Clinical Trial Registry (ChiCTR 2000029544). Results: Baloxavir acid showed antiviral activity in vitro with the half-maximal effective concentration (EC 50 ) of 5.48 μM comparable to arbidol and lopinavir, but favipiravir didn't demonstrate significant antiviral activity up to 100 μM. Thirty patients were enrolled. The percentage of patients who turned viral negative after 14-day treatment was 70%, 77%, and 100% in the baloxavir marboxil, favipiravir, and control group respectively, with the medians of time from randomization to clinical improvement was 14, 14 and 15 days, respectively. One reason for the lack of virological effect and clinical benefits may be due to insufficient concentrations of these drugs relative to their antiviral activities. One of the limitations of this study is the time from symptom onset to randomization, especially in the baloxavir marboxil and control groups, which is higher than the favipiravir group. Conclusions: Our findings could not prove a benefit of addition of either baloxavir marboxil or favipiravir under the trial dosages to the existing standard treatment.
Supplementary Data: Supplementary materials are available online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Adverse events that occurred in more than 1 patient after randomization through day 14 are shown. Some patients had more than one adverse event. There was no death in the trial. ARDS indicates acute respiratory distress syndrome. CRediT authorship contribution statement Declaration of Competing Interest We declare no competing interests. Supplementary materials Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.ejps.2020.105631.
Abdelnabi, Morais, Leyssen, Understanding the Mechanism of the Broad-Spectrum Antiviral Activity of Favipiravir (T-705): Key Role of the F1 Motif of the Viral Polymerase, J Virol, doi:10.1128/jvi.00487-17
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Late treatment
is less effective
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