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Prospective Systematic Data Collection in Early COVID-19 Patients: A Protocol for Individualized Treatment and Outcomes Research

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Submitted:

01 September 2020

Posted:

04 September 2020

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Abstract
Human infection caused by the SARS-CoV-2 virus, called COVID-19, is a new pandemic with devastating effects worldwide. Science seeks the rational and systematic explanation of phenomena. In pandemics, decisions on prevention and treatment of people should be consistently taken, supported by scientific knowledge and ethical principles to produce more good than harm. At first, prospective observational studies to systematically collect patient data, correlating protective or therapeutic interventions with outcomes to assess effectiveness and safety, should be prioritized as the most appropriate type of study. The proposed protocol in this article aims to provide doctors with information on the reduction of harm in early COVID-19 patients by applying individualized interventionist or expectant therapeutic strategies, respecting the autonomy and preferences of physicians and patients in clinical decision-making. The evaluation of the clinical status, besides laboratory confirmation of COVID-19, comprises an individualized symptom score for each patient, a global self-perception scale of the severity of the disease, a clinical progression scale developed by the WHO for clinical studies in COVID-19 and, at the first consultation, doctors´ overall impression on the clinical prognosis. The analysis of anonymized data should preferably use descriptive and inferential statistical resources. The case report form is available for free use in the protocol, along with examples of patient informed consent forms for the prescription of off-label medications and authorization to use the data. Their results may be useful to indicate interventions that are candidates for efficacy trials, in randomized controlled trials, with a higher chance of success. It respects the autonomy and preferences of doctors and patients to decide the best options for treatment in uncertain situations. It also allows the gathering of useful information for future more rigorous clinical trials, trying to link science, ethics, and personal clinical experience.
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Subject: Biology and Life Sciences  -   Virology
Copyright: This open access article is published under a Creative Commons CC BY 4.0 license, which permit the free download, distribution, and reuse, provided that the author and preprint are cited in any reuse.
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