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,..
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