A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics
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.
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improvement in viral load reduction rate, 71.0% lower, relative rate 0.29, p = 0.51, treatment 27, control 26.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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).
Abstract: ARTICLE
https://doi.org/10.1038/s41467-020-19056-6
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 (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.
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: helge.rosjo@medisin.uio.no
NATURE COMMUNICATIONS | (2020)11:5284 | https://doi.org/10.1038/s41467-020-19056-6 | www.nature.com/naturecommunications
1
ARTICLE
NATURE COMMUNICATIONS | https://doi.org/10.1038/s41467-020-19056-6
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..
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