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0 0.5 1 1.5 2+ Mortality 4% Improvement Relative Risk Improvement in viral load.. 71% Lyngbakken et al. NCT04316377 HCQ RCT LATE TREATMENT Is late treatment with HCQ beneficial for COVID-19? RCT 53 patients in Norway Improved viral reduction rate with HCQ (not stat. sig., p=0.51) Lyngbakken et al., Nature Communications, doi:10.1038/s41467-020-19056-6 Favors HCQ Favors control
A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics
Lyngbakken et al., Nature Communications, doi:10.1038/s41467-020-19056-6, NCT04316377 (history)
Lyngbakken et al., A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease.., Nature Communications, doi:10.1038/s41467-020-19056-6, NCT04316377
Jul 2020   Source   PDF  
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Small RCT of nasopharyngeal viral load not showing significant differences. The rate of reduction for HCQ was 0.24 [0.03-0.46] RNA copies/mL/24h, and 0.14 [-0.10-0.37] for the control group (71% faster with HCQ but not statistically significant with the small sample size of 27 HCQ and 26 control patients). Analysis only over 96 hours. NCT04316377 (history).
risk of death, 3.7% lower, RR 0.96, p = 1.00, treatment 1 of 27 (3.7%), control 1 of 26 (3.8%), NNT 702.
improvement in viral load reduction rate, 71.0% lower, relative rate 0.29, p = 0.51, treatment 27, control 26.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lyngbakken et al., 17 Jul 2020, Randomized Controlled Trial, Norway, peer-reviewed, median age 62.0, 11 authors, average treatment delay 8.0 days, trial NCT04316377 (history).
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Abstract: ARTICLE OPEN A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics 1234567890():,; Magnus Nakrem Lyngbakken 1,2, Jan-Erik Berdal2,3, Arne Eskesen3, Dag Kvale 2,4, Inge Christoffer Olsen5, Corina Silvia Rueegg 5,6, Anbjørg Rangberg7, Christine Monceyron Jonassen7, Torbjørn Omland1,2, Helge Røsjø 2,8 ✉ & Olav Dalgard2,3 Here, we randomized 53 patients hospitalized with coronavirus disease 2019 (COVID-19) to hydroxychloroquine therapy (at a dose of 400 mg twice daily for seven days) in addition to standard care or standard care alone ( Identifier, NCT04316377). All severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients 18 years of age or older were eligible for study inclusion if they had moderately severe COVID-19 at admission. Treatment with hydroxychloroquine did not result in a significantly greater rate of decline in SARS-CoV-2 oropharyngeal viral load compared to standard care alone during the first five days. Our results suggest no important antiviral effect of hydroxychloroquine in humans infected with SARS-CoV-2. 1 Division of Medicine, Akershus University Hospital, Lørenskog, Norway. 2 Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. 3 Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway. 4 Department of Infectious Diseases, Oslo University Hospital, Oslo, Norway. 5 Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway. 6 Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway. 7 Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway. 8 Division of Research and Innovation, Akershus University Hospital, Lørenskog, Norway. ✉email: NATURE COMMUNICATIONS | (2020)11:5284 | | 1 ARTICLE NATURE COMMUNICATIONS | H ydroxychloroquine is a registered therapeutic against malaria and several autoimmune conditions, and has in vitro inhibitory effects on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nontoxic concentrations1. In a recent report, hydroxychloroquine given more than 2 weeks after first symptoms had no effect on the clearance of SARS-CoV-2 in various respiratory tract specimens of afebrile patients hospitalized with coronavirus 2019 (COVID-19) partly pretreated with antiviral drugs2. Viral clearance is however an incomplete characterization of viral kinetics, and the impact of hydroxychloroquine therapy on SARS-CoV-2 viral kinetics in subjects hospitalized with COVID-19 remains to be elucidated. Hydroxychloroquine is postulated to affect viral replication, and it is reasonable to assume that an effective antiviral drug will affect respiratory tract viral titers and thereby improve the symptoms and host inflammatory responses, including the cytokine and chemokine expression that is likely responsible for many of the clinical symptoms of COVID-193. Here we report findings from a two-arm, open label, pragmatic randomized controlled trial, the Norwegian Coronavirus Disease 2019 (NO COVID-19) Study (NCT04316377), that assessed the efficacy and safety of hydroxychloroquine therapy on SARS-CoV-2 oropharyngeal viral kinetics in patients..
Late treatment
is less effective
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