Results from expanded access programs: a review of academic literature 145 7♦ Categorization of endpoints in COVID-19-related expanded access publications. Methodological approach 1. Text search for ‘Outcomes’ or ‘endpoints’. In case not found, proceed to step 2. 2. Manual assessment of Abstract and conclusion. In case not found, proceed to step 3. 3. Manual assessment of ‘Methods’ and ‘Results’ section. 4. For Case reports, we only assessed measurements that were performed during or following treatment with expanded access medication. 5. Identified terms were grouped when similar according to the Table below. Category Included terms Viral load SARS-Cov-2 negative conversion, COVID-19 PCR, COVID-19 serum antibody tests, COVID-19 viral load, microbiological cure Mortality All-cause 28 day mortality, survival, crude mortality, death, mortality rate Hospital discharge rate Hospital discharge rate, duration in hospital, days in hospital Inflammatory markers IL-6, pro-inflammatory biomarkers, NK-cell count, leukocyte counts, immune monitoring, cytokine response, inflammatory mediators, biomarkers associated with complement activation, CRP, fibrinogen, D-dimer, urea, ferritin, LDH Oxygen support Oxygen requirement, supplemental oxygen, return to room air (RTRA), oxygenation Respiratory support Ventilated, mechanical ventilation, ventilator-free days, respiratory function, respiratory improvement, extra-corporeal membrane-oxygenation (ECMO) O2 saturation Oxygen saturation, markers of tissue hypoxia Days in intensive care unit Days in intensive care unit, ICU-free days Clinical improvement SAPS II score, multi organ dysfunction score (MODS), disease severity score, clinical improvement meeting the discharge criteria, physician-reported clinical status, successful clinical outcome, clinical recovery, clinical status, clinical cure, Sepsis-related Organ Failure Assessment (SOFA) Score Radiological change Tayler’s scale, radiological findings, Computed Tomography findings, lung opacities, ground class opacities, patchy opacities Adverse Events Adverse events, TESAEs, Serious adverse events, abnormal laboratory measurements (primarily regarding liver function, e.g., ALT, AST) Decrease in symptoms Symptoms, symptomatology PaO2/FiO2 Oxygenation if referred to PaO2/FiO2 Inotropic support Inotropic support, vasopressor usage Laboratory values Biochemical parameters, blood values, chemistry, clinical chemistry parameters, hemoglobin, and platelet count + complete blood count, coagulation + hematology parameters, ABT, ALT, AST, liver function Vital signs Vital signs Transfusion reactions Transfusion reactions Acute care facility length of stay Acute care facility length of stay Time to unfavorable outcome Time to unfavorable outcome Treatment escalation Treatment escalation
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