Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim analysis of a remotely conducted randomized clinical trial
MD Ravi K Amaravadi, Lydia Giles, Mary Carberry, MD PhD Matthew C Hyman, MD Ian Frank, MD Sunita D Nasta, Jennifer Walsh, E Paul Wileyto, PhD Phyllis Gimotty, MD PhD Michael Milone, BA Edith M Teng, MBS Niraj J Vyas, MD Steve Balian, BA Jonathan A Kolansky, BS Nabil M Abdulhay, BS BSN Shaun K Mcgovern, BA Sarah Gamblin, BS Olivia Doran, BA Paul L Callahan, MD MPhil Benjamin S Abella
doi:10.1101/2021.02.22.21252228
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. Secondary outcomes included the participant-reported secondary infection of co-inhabitants, hospitalization, treatment-related adverse events, time to symptom improvement, and incidence of cardiac arrhythmia.
Results .
References
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doi:10.7326/M20-4207DOI record:
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"abstract": "<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the efficacy of hydroxychloroquine to reduce time in quarantine for symptomatic ≥40 years-old COVID-19 patients.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>A randomized, double-blind, placebo-controlled clinical trial.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Outpatients with polymerase chain reaction confirmed COVID-19 at a University of Pennsylvania affiliated testing center between April 15, 2020 and, July 14, 2020.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>Out of 5511 SARS-CoV-2 positive patients, 1072 met initial eligibility criteria for telephone-based recruitment, but only 34 subjects were able to be randomized.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Hydroxychloroquine 400 mg per twice daily (n=17) or matching placebo (n=17), taken orally for up to 14 days.</jats:p></jats:sec><jats:sec><jats:title>Measurements</jats:title><jats:p>The primary outcome was the time to release from quarantine. Secondary outcomes included the participant-reported secondary infection of co-inhabitants, hospitalization, treatment-related adverse events, time to symptom improvement, and incidence of cardiac arrhythmia.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The median time to release from quarantine for HCQ-treated vs. placebo-treated participants was 8 days (range 4-19 days) vs. 11 days (4-18 days); z-score +0.58, p=n.s. This did not meet the pre-specified criteria for early termination, however, this study was terminated early due to lack of feasibility. There was no mortality in either study arm.</jats:p></jats:sec><jats:sec><jats:title>Limitation</jats:title><jats:p>Since this study was terminated early due to a lack of feasibility, no conclusion can be made about the efficacy of hydroxychloroquine as a treatment for COVID-19 patients 40 years of age or older quarantined at home.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The design of this remotely conducted study could guide testing of other more promising agents during the COVID-19 pandemic.</jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p><jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"http://Clinicaltrials.gov\">Clinicaltrials.gov</jats:ext-link> identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04329923\">NCT04329923</jats:ext-link></jats:p></jats:sec>",
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