Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.02.22.21252228; this version posted February 26, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.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 . Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim analysis of a remotely conducted randomized clinical trial Ravi K. Amaravadi, MD1*, Lydia Giles1; Mary Carberry1, Matthew C. Hyman, MD PhD2; Ian Frank, MD3; Sunita D. Nasta, MD1; Jennifer Walsh1; E. Paul Wileyto, PhD5; Phyllis Gimotty, PhD5; Michael Milone, MD PhD6; Edith M. Teng, BA7, Niraj J. Vyas, MBS7, Steve Balian, MD7, Jonathan A. Kolansky, BA7, Nabil M. Abdulhay, BS7, Shaun K. McGovern, BS BSN7, Sarah Gamblin, BA7, Olivia Doran, BS7, Paul L. Callahan, BA7, Benjamin S. Abella MD MPhil7 Affiliations: 1- Abramson Cancer Center and Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania 2- Division of Cardiology, Department of Medicine University of Pennsylvania 3- Division of Infectious Disease, Department of Medicine University of Pennsylvania 4- Department of Microbiology, University of Pennsylvania 5- Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania 6- Department of Pathology, University of Pennsylvania 7-Department of Emergency Medicine, University of Pennsylvania *Corresponding author: Ravi Amaravadi, MD Division of Hematology-Oncology 8 BRB - Room 852 Philadelphia, PA 19104 Office: 215-769-5159 Email: ravi.amaravadi@pennmedicine.upenn.edu Conflict of Interest Statement: The authors report no relevant conflicts of interest Abstract word count:262 Manuscript word count:3497 Key words: COVID-19, hydroxychloroquine Running Title: Trial of hydroxychloroquine for outpatient treatment of COVID-19 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2021.02.22.21252228; this version posted February 26, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.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 . Amaravadi et al ‐ Trial of hydroxychloroquine for outpatient treatment of COVID‐19 2 ABSTRACT Background Older patients are at risk of increased morbidity and mortality from COVID-19 disease due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). There are few effective treatments for outpatients with COVID-19. Objective To evaluate the efficacy of hydroxychloroquine to reduce time in quarantine for symptomatic ≥40 years-old COVID-19 patients. Design A randomized, double-blind, placebo-controlled clinical trial. Setting Outpatients with polymerase chain reaction confirmed COVID-19 at a University of Pennsylvania affiliated testing center between April 15, 2020 and, July 14, 2020. Participants Out of 5511 SARS-CoV-2 positive patients, 1072 met initial eligibility criteria for telephonebased recruitment, but only 34 subjects were able to be randomized. Interventions Hydroxychloroquine 400 mg per twice daily (n=17) or matching placebo (n=17), taken orally for up to 14 days. Measurements The primary outcome was the time to release from quarantine...