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

Abstract

This Viewpoint uses the absence of known effective treatment for Ebola virus disease to emphasize the costs of off-label and compassionate drug use during an infectious disease outbreak and the importance of establishing the efficacy and safety of promising drug leads in randomized trials to inform their clinical use.

Review of Current Evidence of Hydroxychloroquine in Pharmacotherapy of COVID-19

“…Total 71 articles were identified on initial search of databases as of 15th April, following screening of titles and abstracts and removal of duplicates, the articles of relevance (three invitro studies, 20,21,22 two open label non randomized trials, 23,24 two open label RCTs, 25,26 one follow-up study, 27 three reviews, 28,29,30 ten short communications [31][32][33][34][35][36][37][38][39][40] ) were selected for further data extraction and analyses. We identified 88 clinical trials registered in three clinical trial registry databases.…”

Recomendaciones de «hacer» y «no hacer» en el tratamiento de los pacientes críticos ante la pandemia por coronavirus causante de COVID-19 de los Grupos de Trabajo de la Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)

“…La baja sensibilidad de la PCR en las muestras de tracto respiratorio superior mediante hisopo nasal o faríngeo, hace que, en caso de que se trate de pacientes con alta sospecha clínica de COVID-19, sea necesario o bien repetir la determinación en una nueva muestra de tracto respiratorio superior, o bien tratar de conseguir una muestra de tracto respiratorio inferior (48).…”

“…La simulación clínica como herramienta docente nos permite entrenar intervenciones en un entorno seguro, minimizando errores y aumentando la seguridad de profesionales y pacientes (94,111,112). El tratamiento con combinado con lopinavir/ritonavir + hidroxicloroquina presenta importantes efectos secundarios (48). Se aconseja disponer de un listado de las interacciones con los fármacos más frecuentemente empleados para minimizar efectos adversos.…”

Ivermectin and COVID-19: Keeping Rigor in Times of Urgency

“…However, evidence from animal models showing up to 3-fold higher levels in pulmonary tissue than in plasma 1 week after oral dosing leaves the door open for further research, in particular for the treatment of respiratory viruses. 25,26 The discovery of ivermectin's activity against SARS-CoV-2 gives reason for hope, but off-label and compassionate use requires careful risk-benefit considerations, 27 especially in critically ill patients. A path to consider is evaluation first of impacts on virologic outcomes in uncomplicated, low-risk patients early in the course of the disease.…”