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0 0.5 1 1.5 2+ Death at day 28 46% Improvement Relative Risk Combined intubation/de.. 26% Dubee et al. NCT04325893 HCQ RCT LATE TREATMENT Is late treatment with HCQ beneficial for COVID-19? RCT 247 patients in France Lower mortality (p=0.21) and death/intubation (p=0.48), not stat. sig. Dubee et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.03.005 Favors HCQ Favors control
Hydroxychloroquine in mild-to-moderate COVID-19: a placebo-controlled double blind trial
Dubee et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.03.005 (date from earlier preprint), NCT04325893 (history)
Dubee et al., Hydroxychloroquine in mild-to-moderate COVID-19: a placebo-controlled double blind trial, Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.03.005 (date from earlier preprint), NCT04325893
Oct 2020   Source   PDF  
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Small early terminated late stage (60% on oxygen) RCT in France showing 46% lower mortality.
mortality at 28 days relative risk RR 0.54 [0.21-1.42]
combined mortality/intubation at 28 days relative risk RR 0.74 [0.33-1.70]
If not stopped early and the same trend continued, statistical significance would be reached on 28 day mortality after ~550 patients (1,300 patients were planned).
Mortality results are not provided for subgroups. For the subgroups receiving AZ:
No safety concerns were identified. This study has been presented as negative, however the results do not support that conclusion.
NCT04325893 (history)
risk of death at day 28, 46.0% lower, RR 0.54, p = 0.21, treatment 6 of 124 (4.8%), control 11 of 123 (8.9%), NNT 24.
risk of combined intubation/death at day 28, 26.0% lower, RR 0.74, p = 0.48, treatment 9 of 124 (7.3%), control 12 of 123 (9.8%), NNT 40.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Dubee et al., 21 Oct 2020, Randomized Controlled Trial, France, peer-reviewed, median age 77.0, 18 authors, average treatment delay 5.0 days, trial NCT04325893 (history).
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This PaperHCQAll
Abstract: Clinical Microbiology and Infection 27 (2021) 1124e1130 Contents lists available at ScienceDirect Clinical Microbiology and Infection journal homepage: Original article Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial e 1, 2, *, x, Pierre-Marie Roy 3, 4, x, Bruno Vielle 5, Elsa Parot-Schinkel 5, Vincent Dube Odile Blanchet 6, Astrid Darsonval 7, Caroline Lefeuvre 8, Chadi Abbara 9, Sophie Boucher 4, 10, Edouard Devaud 11, Olivier Robineau 12, Patrick Rispal 13, Thomas Guimard 14, Emma d’Anglejean 15, Sylvain Diamantis 16, Marc-Antoine Custaud 4, 17, Isabelle Pellier 18, Alain Mercat 19, for the HYCOVID study groupy 1) Service des Maladies Infectieuses et Tropicales, CHU d’Angers, Angers, France CRCINA, Inserm, Universit e de Nantes, Universit e d’Angers, Angers, France 3) Emergency Department, CHU d’Angers, Angers, France 4) Institut MitoVasc, UMR CNRS 6215 INSERM 1083, Universit e d’Angers, Angers, France 5) Biostatistics and Methodology Department, Maison de La Recherche, CHU d’Angers, Angers, France 6) Centre de Ressources Biologiques, BB-0033-00038, CHU d’Angers, Angers, France 7) Service Pharmacie, CHU d’Angers, Angers, France 8)  Departement des Agents Infectieux, Laboratoire de Virologie, CHU Angers, Angers, France 9) Laboratoire de Pharmacologiedtoxicologie, CHU d’Angers, Angers, France 10) Service d’ORL et Chirurgie Cervico-faciale, CHU d’Angers, Angers, France 11) Service de M edecine Interne et Maladies Infectieuses, CH R. Dubos, Pontoise, France 12) Service Universitaire des Maladies Infectieuses et du Voyageur, CH de Tourcoing, Tourcoing, France 13) Service de M edecine Interne, CH Agen, Agen, France 14) Service de M edecine Post-urgence, CH D epartemental de Vend ee, La Roche sur Yon, France 15) ^pital Andr Service de M edecine Interne et Maladies Infectieuses, CH VersaillesdHo e Mignot, Le Chesnay, France 16) Service de M edecine Polyvalente et Maladies Infectieuses, Groupe Hospitalier Sud Ile de France, Melun, France 17) Centre de Recherche Clinique, CHU d’Angers, Angers, France 18) Unit e d'h ematologie et d'oncologie P ediatrique, CHU d’Angers, Inserm U1232-CRCINA, Universit e d’Angers, Angers, France 19)  Departement de M edecine Intensive-R eanimation, CHU d’Angers, Universit e d’Angers, Angers, France 2) a r t i c l e i n f o Article history: Received 10 January 2021 Received in revised form 19 March 2021 Accepted 21 March 2021 Available online 1 April 2021 Editor: L. Leibovici Keywords: Coronavirus disease 2019 Hydroxychloroquine Placebo-controlled Randomized controlled trial Severe acute respiratory syndrome coronavirus 2 a b s t r a c t Objectives: To determine whether hydroxychloroquine decreases the risk of adverse outcome in patients with mild to moderate coronavirus disease 2019 (COVID-19) at high risk of worsening. Methods: We conducted a multicentre randomized double-blind placebo-controlled trial evaluating hydroxychloroquine in COVID-19 patients with at least one of the following risk factors for worsening: need for supplemental oxygen, age 75 years, age between 60 and 74 years and presence of at least one co-morbidity. Severely ill patients requiring oxygen therapy >3 L/min or intensive care were excluded. Eligible patients were randomized in a 1:1 ratio to receive either 800 mg hydroxychloroquine on day 0 followed by 400 mg per day for 8 days or a placebo. The primary end point..
Late treatment
is less effective
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