Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim analysis of a remotely conducted randomized clinical trial
Amaravadi et al.,
Hydroxychloroquine for SARS-CoV-2 positive patients quarantined at home: The first interim analysis of a..,
medRxiv, doi:10.1101/2021.02.22.21252228 (Preprint)
Tiny early-terminated 34 patient RCT for outpatient treatment showing faster recovery with treatment (not statistically significant). All patients recovered (3 control patients recovered after crossover to the treatment arm) - as per protocol mid-recovery results have priority. There was no mortality and only one hospitalization on day 0 before treatment. There were no severe adverse events.
risk of not reaching lowest symptom score at day 7 mid-recovery, 60.0% lower, RR 0.40, p = 0.13, treatment 3 of 15 (20.0%), control 6 of 12 (50.0%), NNT 3.3.
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risk of not reaching lowest symptom score at day 5 mid-recovery, 50.0% lower, RR 0.50, p = 0.13, treatment 5 of 15 (33.3%), control 8 of 12 (66.7%), NNT 3.0.
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relative time to first occurrence of lowest symptom score, 42.9% lower, relative time 0.57, p = 0.38, treatment median 4.0 IQR 13.0 n=15, control median 7.0 IQR 10.0 n=12.
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relative time to release from quarantine, 27.3% lower, relative time 0.73, p = 0.46, treatment median 8.0 IQR 15.0 n=16, control median 11.0 IQR 14.0 n=13, primary outcome.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Amaravadi et al., 26 Feb 2021, Double Blind Randomized Controlled Trial, USA, preprint, 20 authors, dosage 400mg bid days 1-14.
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(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.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
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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...
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