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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
Jul 2020  
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Mortality 4% Improvement Relative Risk Improvement in viral load.. 71% HCQ  Lyngbakken et al.  LATE TREATMENT  RCT 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) c19hcq.org Lyngbakken et al., Nature Communications, Jul 2020 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 419 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 109 treatments. c19hcq.org
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).
This PaperHCQAll
A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics
Magnus Nakrem Lyngbakken, Jan-Erik Berdal, Arne Eskesen, Dag Kvale, Inge Christoffer Olsen, Corina Silvia Rueegg, Anbjørg Rangberg, Christine Monceyron Jonassen, Torbjørn Omland, Helge Røsjø, Olav Dalgard
Nature Communications, doi:10.1038/s41467-020-19056-6
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 (ClinicalTrials.gov 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.
Author contributions M.N.L., coordinating investigator, prepared the trial protocol, handled regulatory approvals, drafted the manuscript. J.E.B., investigator, study sponsor, critically reviewed the manuscript and approved the final manuscript as submitted. A.E., investigator, inclusion of patients, critically reviewed the manuscript and approved the final manuscript as submitted. D.K., investigator, laboratory and analytical support, critically reviewed the manuscript and approved the final manuscript as submitted. I.C.O., trial statistician, prepared the trial protocol, critically reviewed the manuscript, and approved the final manuscript as submitted. C.S.R., trial statistician, critically reviewed the manuscript and approved the final manuscript as submitted. A.R., investigator, laboratory and analytical support, critically reviewed the manuscript and approved the final manuscript as submitted. C.M.J., investigator, laboratory and analytical support, critically reviewed the manuscript and approved the final manuscript as submitted. T.O., investigator, critically reviewed the manuscript and approved the final manuscript as submitted. H.R., investigator, conceived the idea for the study, prepared the trial protocol, handled regulatory approvals, critically reviewed the manuscript, and approved the final manuscript as submitted. O.D., principal investigator, prepared the trial protocol, handled regulatory approvals, inclusion of patients, critically reviewed the manuscript,..
References
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Late treatment
is less effective
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