Die „historische Studie“ SOLIDARITY als Antwort der Forschung auf die Sars-CoV-2 Pandemie

Abstract

The "Historic Study" SOLIDARITY-Research's Answer to the Sars-CoV-2 Pandemic This paper is part of Forum COVID-19: Perspectives in the Humanities and Social Sciences. The novel coronavirus (Sars-CoV-2) poses a huge challenge to the world community. Knowledge about the virus and its properties is limited, but there is a great need to base political and medical decisions on scientific knowledge. This situation is leading to a dynamization of research. A prominent example of such a development is SOLIDARITY. The epistemological dimensions of this trial, which is coordinated by the WHO, and the resulting ethical implications are discussed in this article. Dieser Beitrag ist Teil des Forums COVID-19: Perspektiven in den Geistes-und Sozialwissenschaften. Das neuartige Coronavirus (Sars-CoV-2) stellt die Weltgemeinschaft vor eine große Herausforderung. Das Wissen über das Virus und seine Eigenschaften ist lückenhaft, aber der Bedarf, politische und medizinische Entscheidungen an wissenschaftlicher Erkenntnis auszurichten ist groß. Diese Lage führt zu einer Dynamisierung der Forschung. Ein prominentes Beispiel ist die WHO-Studie SOLIDARITY. Die epistemologischen Besonderheiten und die daraus resultierenden ethischen Implikationen werden in diesem Beitrag näher beleuchtet.

Medication of Hydroxychloroquine, Remdesivir and Convalescent Plasma during the COVID-19 Pandemic in Germany—An Ethical Analysis

“…In addition, so-called sleeping candidates were tested. These are drugs that have been abandoned during the development process because they have proven to be insufficiently effective for the originally intended medical application or have unwanted side effects [ 12 ]. Drugs were used experimentally and were gradually granted drug approval, deviating from standard procedure.…”

“…Failure to provide timely access has been suggested as a reason for deviating from established study designs during the pandemic [ 27 ]. Weaker evidence is accepted when this allows us to offer life-saving therapy more quickly [ 12 ]. The use of drugs in off-label use and compassionate use follows the principle of beneficence and does not primarily serve scientific purposes, such as gaining knowledge about the effectiveness of drugs [ 27 , 33 ].…”

“…However, remdesivir was not approved for the treatment of hepatitis C or Ebola because the drug did not meet efficacy requirements [ 35 ]. The drug can be described as a sleeping candidate [ 12 ]. The emergence of the new disease was a sudden unexpected opportunity to finally give remdesivir a major use.…”

Screening druggable targets and predicting therapeutic drugs for COVID-19 via integrated bioinformatics analysis

“…In a WHO-sponsored international clinical trial, on 17 June 2020, it was announced that the hydroxychloroquine section of the Solidarity trial was discontinued due to concerns about the safety of hydroxychloroquine and its associated adverse cardiac events, as it had failed to reduce mortality in hospitalized COVID-19 patients (Gadebusch Bondio and Marloth. 2020 ; Rosenberg et al 2020 ). Should we deny hydroxychloroquine completely based on this statement?…”

“…Should we deny hydroxychloroquine completely based on this statement? In response to the decision to withdraw hydroxychloroquine from the Solidarity trial, WHO stated that this decision applies only to hospitalized COVID-19 patients and does not affect the study evaluation on the use of hydroxychloroquine in other non-hospitalized patients, or the evaluation of preexposure and postexposure prevention of COVID-19 (Gadebusch Bondio and Marloth 2020 ). Besides, a considerable amount of literature has demonstrated the antiviral role of hydroxychloroquine and its important immunomodulatory properties, such as its use in systemic lupus, arthritis, and other autoimmune diseases (Rosenberg et al 2020 ).…”