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Expert Rev Anti Infect Ther ; : 1-6, 2021 Nov 29.
Article in English | MEDLINE | ID: covidwho-1522044

ABSTRACT

INTRODUCTION: The COVID-19 pandemic has created an unprecedented opportunity to reimagine clinical research. While much has been written about the challenges associated with generating real-world evidence during the COVID-19 pandemic, comparatively little attention has been paid to the ethical challenges facing patients, clinicians, researchers, and regulatory bodies. AREAS COVERED: In this manuscript, we examine these challenges through the lens of informed consent and explore how the consenting process changes as our understanding of the disease is altered. EXPERT OPINION: We also suggest ways to limit these ethical hurdles through the use of embedded pragmatic clinical trials, which generate real-world data without the limitations associated with observational trials or the resources and lack of generalizability that are obstacles to conducting conventional randomized clinical trials. We argue that clinical research must become more nimble, and must include embedded researchers to ensure that relevant questions and ethical issues are properly addressed.

2.
Infect Dis Ther ; 9(3): 435-449, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-381948

ABSTRACT

The emergence of SARS-CoV-2/2019 novel coronavirus (COVID-19) has created a global pandemic with no approved treatments or vaccines. Many treatments have already been administered to COVID-19 patients but have not been systematically evaluated. We performed a systematic literature review to identify all treatments reported to be administered to COVID-19 patients and to assess time to clinically meaningful response for treatments with sufficient data. We searched PubMed, BioRxiv, MedRxiv, and ChinaXiv for articles reporting treatments for COVID-19 patients published between 1 December 2019 and 27 March 2020. Data were analyzed descriptively. Of the 2706 articles identified, 155 studies met the inclusion criteria, comprising 9152 patients. The cohort was 45.4% female and 98.3% hospitalized, and mean (SD) age was 44.4 years (SD 21.0). The most frequently administered drug classes were antivirals, antibiotics, and corticosteroids, and of the 115 reported drugs, the most frequently administered was combination lopinavir/ritonavir, which was associated with a time to clinically meaningful response (complete symptom resolution or hospital discharge) of 11.7 (1.09) days. There were insufficient data to compare across treatments. Many treatments have been administered to the first 9152 reported cases of COVID-19. These data serve as the basis for an open-source registry of all reported treatments given to COVID-19 patients at www.CDCN.org/CORONA . Further work is needed to prioritize drugs for investigation in well-controlled clinical trials and treatment protocols.

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