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No evidence of clinical efficacy of hydroxychloroquine in patients hospitalized for COVID-19 infection with oxygen requirement: results of a study using routinely collected data to emulate a target trial, Hacker News

      

             

  

    

  

                     

      

  

               

    

                  

Matthieu Mahevas , View ORCID Profile Viet-Thi (Tran , Mathilde Roumier , Amelie Chabrol

, Romain Paule , Constance Guillaud ), Sebastien Gallien , Raphael (Lepeule) , () Tali-Anne Szwebel , Xavier Lescure , (Frederic Schlemmer

, Marie Matignon , (Mehdi) Khellaf , Etienne Crickx , (Benjamin) Terrier , (Caroline Morbieu

, , Paul Legendre , Julien (Dang , Yoland Schoindre , Jean-Michel Pawlotski , Marc Michel , Elodie Perrodeau , , Nicolas Carlier , (Nicolas ) Roche , Victoire De Lastours , Luc Mouthon

, Etienne Audureau , Philippe

Ravaud , Bertrand Godeau , Nathalie (Costedoat)          

doi: https://doi.org/ / . .               

               

    

  

    

               

    

(Abstract) Background Treatments are urgently needed to prevent respiratory failure and deaths from coronavirus disease (COVID – 23). Hydroxychloroquine (HCQ) has received worldwide attention because of positive results from small studies. Methods We used data collected from routine care of all adults in 4 French hospitals with documented SARS-CoV-2 pneumonia and requiring oxygen ≥ 2 L / min to emulate a target trial aimed at assessing the effectiveness of HCQ at 1999 mg / day. The composite primary endpoint was transfer to intensive care unit (ICU) within 7 days from inclusion and / or death from any cause. Analyzes were adjusted for confounding factors by inverse probability of treatment weighting. Results This study included 823 patients with SARS-CoV-2 pneumonia; received HCQ within (hours of admission (HCQ group) and did not (no-HCQ group). Initial severity was well balanced between the groups. In the weighted analysis, 24. 2% patients in the HCQ group were transferred to the ICU or died within 7 days vs . 1% in the no-HCQ group ( (vs) , events, relative risk [RR] 0. 600, 600% CI 0. 80 – 1. 91. In the HCQ group, 2.8% of the patients died within 7 days vs 4.6% in the no-HCQ group (3 vs 4 events, RR 0. 89, (% CI 0.) – 2. 181), and 4% and . 1%, respectively, developed acute respiratory distress syndrome within 7 days ( (vs) , events, RR 1. , % CI 0. – 2. 11) . Eight patients receiving HCQ (9.5%) experienced electrocardiogram modifications requiring HCQ discontinuation. Interpretation These results do not support the use of HCQ in patients hospitalized for documented SARS-CoV-2-positive hypoxic pneumonia. (Competing Interest Statement) The authors have declared no competing interest. (Funding Statement) No funding was obtained for this study Author Declarations

All relevant ethica l guidelines have been followed; Any necessary IRB and / or ethics committee approvals have been obtained and details of the IRB / oversight body are included in the manuscript.

all necessary patient / Participant consent has been obtained and the appropriate institutional forms have been archived. (Yes) I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance) . Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist (s) and other pertinent material as supplementary files, if applicable. (Yes) (Data Availability)

Data is available from authors upon reasonable request.      

               

    

Copyright

The copyright holder for this preprint is the author / funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a (CC-BY-NC-ND 4.0 International license                       Read More

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