Repurposing existing medications for coronavirus disease 2019: protocol for a rapid and living systematic review

BACKGROUND Coronavirus disease 2019 (COVID-19) has no confirmed specific treatments. However, there might be in vitro and early clinical data as well as evidence from severe acute respiratory syndrome and Middle Eastern respiratory syndrome that could inform clinicians and researchers. This systematic review aims to create priorities for future research of drugs repurposed for COVID-19. METHODS This systematic review will include in vitro, animal, and clinical studies evaluating the efficacy of a list of 34 specific compounds and 4 groups of drugs identified in a previous scoping review. Studies will be identified both from traditional literature databases and pre-print servers. Outcomes assessed will include time to clinical improvement, time to viral clearance, mortality, length of hospital stay, and proportions transferred to the intensive care unit and intubated, respectively. We will use the GRADE methodology to assess the quality of the evidence. DISCUSSION The challenge posed by COVID-19 requires not just a rapid review of drugs that can be repurposed but also a sustained effort to integrate new evidence into a living systematic review. TRIAL REGISTRATION PROSPERO 2020 CRD42020175648

Beyond Consent: A Relational Model of Community Authorization for Genetically Modified Mosquito Trials in Developing Countries

This thesis provides the first empirical explanatory theory for community authorization for Genetically Modified Mosquito (GMM) trials. Although this theory was developed in the context of GMM trials, it can apply to other endeavors, research or not, where whole communities might be affected. As GMM make their way from laboratories to villages of developing countries to test their effectiveness in controlling vector-borne diseases, community authorization emerges as a critical and urgent, yet undefined, mechanism of protection and respect for communities who might be affected by research and its outcomes.Following a constructivist Grounded Theory approach, I analyzed three prominent GMM trials from Mexico, the Cayman Islands, and Malaysia. Nineteen (19) interviews and two hundred and forty nine (249) documents were analyzed in order to uncover the substantive and procedural aspects of authentic and sufficient community authorization for research, as well as the factors that affect such authorization.This interdisciplinary bioethics thesis supports a relational notion of community authorization, as a continuous state of ongoing, maintenance-dependent, approval for research from inception through all stages. Enabled by successful relationships between researchers and community groups and individuals, this state manifests in formal and informal ways at all levels of the community; institutional, national, regional, local, and even individual, and involves authorities, both official and traditional, and publics alike. The state of authorization manifests in reciprocity, or the fulfillment of commitment to promote mutual interests. The findings challenge current conceptions of research participants as well as consent, and consequently current practices of research appraisal. Future research is needed to provide researchers, research ethics boards, and regulatory agencies with standardized tools to gauge the conduct of research in relationship to the community. The elements of this theory, as well as its reliability, applicability and generalizability, need to be tested and refined in future empirical work in multiple contexts and different fields.Ph.D

Repurposing Existing Medications for Coronavirus Disease 2019: Protocol for a Rapid and Living Systematic Review

Background: Coronavirus Disease 2019 (COVID-19) has no known specific treatments. However, there might be in vitro and early clinical data as well as evidence from Severe Acute Respiratory Syndrome and Middle Eastern Respiratory Syndrome that could inform clinicians and researchers. This systematic review aims to create priorities for future research of drugs repurposed for COVID-19. Methods: This systematic review will include in vitro, animal, and clinical studies evaluating the efficacy of a list of 34 specific compounds and four groups of drugs identified in a previous scoping review. Studies will be identified both from traditional literature databases and pre-print servers. Outcomes assessed will include time to clinical improvement, time to viral clearance, mortality, length of hospital stay, and proportions transferred to the intensive care unit and intubated, respectively. We will use the GRADE methodology to assess the quality of the evidence. Discussion: The challenge posed by COVID-19 requires not just a rapid review of drugs that can be repurposed but also a sustained effort to integrate new evidence into a living systematic review