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- W4319433125 abstract "Abstract Background: Most COVID-19 cases in the US are managed via outpatient care, yet the outpatient natural history of COVID-19 is not well understood. We assessed outpatient natural history of COVID-19 as part of a clinical food study evaluating KB109 safety and its effects on select health measures when combined with supportive self-care (SSC) vs SSC alone. KB109 is a novel synthetic glycan developed to support immune system homeostasis through gut microbiome modulation. The SSC-alone arm permitted COVID-19 natural history exploration, the focus of this abstract. Methods: Adult patients were randomized 1:1 to SSC alone or SSC+KB109. Randomization was stratified by site, age subgroup, and comorbidity status. Signs/symptoms of COVID-19 and other end points were evaluated over a 35-d study period. Patients self-assessed 8 COVID-19–related cardinal symptoms; 5 additional symptoms were collected (13 overall symptoms). Results: Overall, 350 patients were randomized (SSC alone, n=176). Interim results are presented; full analysis expected in March 2021. In the SSC-alone interim results (n=89), 36.0% of patients self-reported ≥1 comorbidity. Median time to resolution of the 8 cardinal symptoms was 12d in patients with no comorbidities vs 27d in patients with ≥1 comorbidity (HR=1.708 [0.875, 3.332]). Median time to resolution of the 13 overall symptoms was 14d in patients with no comorbidities vs 27d in patients reporting ≥1 comorbidity (HR=1.800 [0.953, 3.400]). The most common comorbidities were hypertension (19.1%) and chronic lung disease (9.0%). Conclusions: This is the first clinical study to show ≥1 comorbidity is associated with a protracted time to resolution of symptoms in non-hospitalized patients with mild to moderate COVID-19." @default.
- W4319433125 created "2023-02-09" @default.
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- W4319433125 date "2021-05-01" @default.
- W4319433125 modified "2023-10-16" @default.
- W4319433125 title "Patient-reported comorbidity affects symptom duration in non-hospitalized patients with mild to moderate COVID-19 in a clinical study" @default.
- W4319433125 doi "https://doi.org/10.4049/jimmunol.206.supp.62.14" @default.
- W4319433125 hasPublicationYear "2021" @default.
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