Safety of hydroxychloroquine, alone and in combination with azithromycin, in light of rapid wide-spread use for COVID-19: a multinational, network cohort and self-controlled case series study

Jennifer C.E Lane; James Weaver; Kristin Kostka; Talita Duarte-Salles; Maria Tereza F. Abrahao; Heba Alghoul; Osaid Alser; Thamir M Alshammari; Patricia Biedermann; Edward Burn; Paula Casajust; Mitch Conover; Aedin C. Culhane; Alexander Davydov; Scott L. DuVall; Dmitry Dymshyts; Sergio Fernández Bertolín; Kristina Fišter; Jill Hardin; Laura Hester; George Hripcsak; Seamus Kent; Sajan Khosla; Spyros Kolovos; Christophe G. Lambert; Johan ver der Lei; Ajit A. Londhe; Kristine E. Lynch; Rupa Makadia; Andrea V. Margulis; Michael E. Matheny; Paras Mehta; Daniel R. Morales; Henry Morgan-Stewart; Mees Mosseveld; Danielle Newby; Fredrik Nyberg; Anna Ostropolets; Rae Woong Park; Albert Prats-Uribe; Gowtham A. Rao; Christian Reich; Jenna Reps; Peter Rijnbeek; Selva Muthu Kumaran Sathappan; Martijn Schuemie; Sarah Seager; Anthony Sena; Azza Shoaibi; Matthew Spotnitz; Marc A. Suchard; Joel Swerdel; Carmen Olga Torre; David Vizcaya; Haini Wen; Marcel de Wilde; Seng Chan You; Lin Zhang; Oleg Zhuk; Patrick Ryan; Daniel Prieto-Alhambra

is the (which was not peer-reviewed) The copyright holder for this preprint . https://doi.org/10.1101/2020.04.08.20054551 doi: medRxiv preprint As with all observational data, this study is limited by its ability to appropriately identify exposure and outcome. Due to the nature of sudden cardiac death, capturing the true cause of cardiovascular related mortality is difficult. We therefore have explored cardiovascular related outcomes other than mortality to determine if deterioration in these pathophysiological processes led to increased mortality. Since this is not seen, and sudden cardiac death in association with prolonged QT interval is described in the literature, our conclusions are drawn from these assumptions. It should be acknowledged that misclassification can occur due to non-adherence or non-compliance with exposure medication, and incomplete lack of recording of SAEs may lead to underestimation of these outcomes.