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/M20-4207{ 'institution': [{'name': 'medRxiv'}],
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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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