scholarly journals Accessing unproven interventions in the COVID-19 pandemic: discussion on the ethics of ‘compassionate therapies’ in times of catastrophic pandemics

2021 ◽  
pp. medethics-2020-106783
Author(s):  
Shlomit Zuckerman ◽  
Yaron Barlavie ◽  
Yaron Niv ◽  
Dana Arad ◽  
Shaul Lev
Keyword(s):  
Ebola Virus ◽  
Virus Disease ◽  
Standard Of Care ◽  
Dynamic Monitoring ◽  
Emergency Setting ◽  
Evaluation Tool ◽  
Compassionate Care ◽  
Compassionate Use ◽  
High Quality Research ◽  
Randomised Controlled

Since the onset of the SARS-CoV-2 pandemic, an array of off-label interventions has been used to treat patients, either provided as compassionate care or tested in clinical trials. There is a challenge in determining the justification for conducting randomised controlled trials over providing compassionate use in an emergency setting. A rapid and more accurate evaluation tool is needed to assess the effect of these treatments. Given the similarity to the Ebola Virus Disease (EVD) pandemic in Africa in 2014, we suggest using a tool designed by the WHO committee in the aftermath of the EVD pandemic: Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). Considering the uncertainty around SARS-CoV-2, we propose using an improved MEURI including the Plan–Do–Study–Act tool. This combined tool may facilitate dynamic monitoring, analysing, re-evaluating and re-authorising emergency use of unproven treatments and repeat it in cycles. It will enable adjustment and application of outcomes to clinical practice according to changing circumstances and increase the production of valuable data to promote the best standard of care and high-quality research—even during a pandemic.

scholarly journals Laboratory Findings, Compassionate Use of Favipiravir, and Outcome in Patients With Ebola Virus Disease, Guinea, 2015—A Retrospective Observational Study

2019 ◽  
Vol 220 (2) ◽  
pp. 195-202 ◽  
Author(s):  
Romy Kerber ◽  
Eva Lorenz ◽  
Sophie Duraffour ◽  
Daouda Sissoko ◽  
Martin Rudolf ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Survival Time ◽  
Ebola Virus ◽  
Virus Disease ◽  
Univariate Analysis ◽  
Case Fatality ◽  
Blood Chemistry ◽  
Ebola Virus Disease ◽  
Treatment Center ◽  
Compassionate Use

Abstract Background In 2015, the laboratory at the Ebola treatment center in Coyah, Guinea, confirmed Ebola virus disease (EVD) in 286 patients. The cycle threshold (Ct) of an Ebola virus–specific reverse transcription–polymerase chain reaction assay and 13 blood chemistry parameters were measured on admission and during hospitalization. Favipiravir treatment was offered to patients with EVD on a compassionate-use basis. Methods To reduce biases in the raw field data, we carefully selected 163 of 286 patients with EVD for a retrospective study to assess associations between potential risk factors, alterations in blood chemistry findings, favipiravir treatment, and outcome. Results The case-fatality rate in favipiravir-treated patients was lower than in untreated patients (42.5% [31 of 73] vs 57.8% [52 of 90]; P = .053 by univariate analysis). In multivariate regression analysis, a higher Ct and a younger age were associated with survival (P < .001), while favipiravir treatment showed no statistically significant effect (P = .11). However, Kaplan-Meier analysis indicated a longer survival time in the favipiravir-treated group (P = .015). The study also showed characteristic changes in blood chemistry findings in patients who died, compared with survivors. Conclusions Consistent with the JIKI trial, this retrospective study revealed a trend toward improved survival in favipiravir- treated patients; however, the effect of treatment was not statistically significant, except for its influence on survival time.

scholarly journals Evaluating Novel Diagnostics in an Outbreak Setting: Lessons Learned from Ebola

2017 ◽  
Vol 55 (5) ◽  
pp. 1255-1261 ◽  
Author(s):  
Nira R. Pollock ◽  
Betsy Wonderly
Keyword(s):  
Ebola Virus ◽  
Virus Disease ◽  
Point Of Care ◽  
Lessons Learned ◽  
Ebola Virus Disease ◽  
Test Evaluation ◽  
Emergency Setting ◽  
Rapid Testing

ABSTRACT Inadequate access to rapid testing for Ebola virus disease during the 2014-to-2016 outbreak led to an explosion in the development of diagnostics that could be performed at or near the point of care and by less-experienced operators, leading in turn to an acute need for novel test evaluation. Here, we present the challenges to development and evaluation of novel diagnostics in an emergency setting and suggestions for potential new “global emergency standards” to address them.

The Moral Case for Granting Catastrophically Ill Patients the Right to Access Unregistered Medical Interventions

2017 ◽  
Vol 45 (3) ◽  
pp. 382-391 ◽  
Author(s):  
Udo Schuklenk ◽  
Ricardo Smalling
Keyword(s):  
Ebola Virus ◽  
Drug Research ◽  
Virus Disease ◽  
Controlled Trial ◽  
Moral Claim ◽  
Trial Recruitment ◽  
Medical Interventions ◽  
Moral Case ◽  
Randomised Controlled ◽  
The Right

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions (UMI), without having to enrol in randomized placebo controlled trials.A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should not prioritise trial recruitment over patient access, even if this results in drug research and development delays.We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial (RCT) is defended.

scholarly journals Is remdesivir the therapeutic answer for COVID-19: a review of current knowledge

2020 ◽  
Vol 9 (9) ◽  
pp. 1462
Author(s):  
Marya Ahsan ◽  
Ayaz Khurram Mallick
Keyword(s):  
Clinical Trials ◽  
Ebola Virus ◽  
Randomized Clinical Trials ◽  
Current Knowledge ◽  
Virus Disease ◽  
Compassionate Use ◽  
Investigational Agent ◽  
Pubmed Database ◽  
Novel Coronavirus ◽  
Real Picture

As the world races to find the solution to the COVID-19 pandemic, an investigational agent which has triggered worldwide interest is remdesivir. Though failing clinical trials for treatment of Ebola virus disease, remdesivir has shown efficacy in numerous viral studies involving SARS-CoV-2. Reports from compassionate use of remdesivir in hospitalized patients of COVID-19 have been promising. But the real picture about the safety and efficacy of remdesivir can only be known after completion of randomized clinical trials. In this review, we aim to highlight the salient features of pharmacokinetics and pharmacodynamics of remdesivir known so far and its plausible role in management of COVID-19. We searched the PubMed database and Google Scholar for published literature using the key words: remdesivir, human coronavirus, novel coronavirus, COVID-19, SARS-CoV 2, mechanism of action, pharmacokinetics, pharmacodynamics and compassionate use till 1st May 2020. The U. S. national library of medical trials registry was searched for ongoing trials with remdesivir among patients of COVID-19. Remdesivir is a prodrug of a nucleoside Analog that inhibits RNA replication by binding to viral RNA dependent RNA polymerase. It is being employed in many global phase-3 clinical trials for evaluating the efficacy and safety of the drug in patients of COVID-19.

Treatment of ebola and other infectious diseases: melatonin “goes viral”

2020 ◽  
Vol 3 (1) ◽  
pp. 43-57 ◽  
Author(s):  
Russel J Reiter ◽  
Qiang Ma ◽  
Ramaswamy Sharma
Keyword(s):  
Mortality Rate ◽  
Infectious Diseases ◽  
Hemorrhagic Shock ◽  
Safety Profile ◽  
Ebola Virus ◽  
Viral Infections ◽  
Virus Disease ◽  
Attractive Potential ◽  
Potential Treatment

This review summarizes published reports on the utility of melatonin as a treatment for virus-mediated diseases. Of special note are the data related to the role of melatonin in influencing Ebola virus disease. This infection and deadly condition has no effective treatment and the published works documenting the ability of melatonin to attenuate the severity of viral infections generally and Ebola infection specifically are considered. The capacity of melatonin to prevent one of the major complications of an Ebola infection, i.e., the hemorrhagic shock syndrome, which often contributes to the high mortality rate, is noteworthy. Considering the high safety profile of melatonin, the fact that it is easily produced, inexpensive and can be self-administered makes it an attractive potential treatment for Ebola virus pathology.  

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