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Treating COVID-19—Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics

Educational Objective
Review the use of off-label drug use and RCTs during the COVID-19 Pandemic
1 Credit CME

In the 2014 Ebola outbreak, close to 30 000 individuals developed Ebola viral disease (EVD), and numerous therapies were tested against this virus, including chloroquine, hydroxychloroquine, favipiravir, brincidofovir, monoclonal antibodies, antisense RNA, and convalescent plasma, among many others. With such a large number of therapeutic interventions given to affected patients, the goal was to determine which was efficacious against Ebola. Ultimately, none proved to be efficacious or safe.

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Article Information

Corresponding Author: Andre C. Kalil, MD, MPH, Department of Internal Medicine, University of Nebraska Medical Center, 95400 Nebraska Medical Center, Omaha, NE 68135 (akalil@unmc.edu).

Published Online: March 24, 2020. doi:10.1001/jama.2020.4742

Conflict of Interest Disclosures: None reported.

References
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2.
Davey  RT  Jr, Dodd  L, Proschan  MA,  et al; PREVAIL II Writing Group; Multi-National PREVAIL II Study Team.  A randomized, controlled trial of ZMapp for Ebola virus infection.  N Engl J Med. 2016;375(15):1448-1456. doi:10.1056/NEJMoa1604330PubMedGoogle ScholarCrossref
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Adaptive COVID-19 Treatment Trial. ClinicalTrials.gov identifier: NCT04280705. Posted February 21, 2020. Accessed March 19, 2020. https://clinicaltrials.gov/ct2/show/NCT04280705?term=remdesivir&cond=covid-19&draw=2&rank=5
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Young  BE, Ong  SWX, Kalimuddin  S,  et al; Singapore 2019 Novel Coronavirus Outbreak Research Team.  Epidemiologic features and clinical course of patients infected With SARS-CoV-2 in Singapore.  JAMA. Published online March 3, 2020. doi:10.1001/jama.2020.3204PubMedGoogle Scholar
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Wu  Z, McGoogan  JM.  Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention.  JAMA. Published online February 24, 2020. doi:10.1001/jama.2020.2648PubMedGoogle Scholar
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Russell  CD, Millar  JE, Baillie  JK.  Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury.  Lancet. 2020;395(10223):473-475. doi:10.1016/S0140-6736(20)30317-2PubMedGoogle ScholarCrossref
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Kalil  AC, Sun  J.  Low-dose steroids for septic shock and severe sepsis: the use of Bayesian statistics to resolve clinical trial controversies.  Intensive Care Med. 2011;37(3):420-429. doi:10.1007/s00134-010-2121-0PubMedGoogle ScholarCrossref
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