Session Type: ePosters
Session Title: ePosters
Authors(s): J. Haran (1), Y. Zheng (2), N. Alonzo-Palma (2), M. Wingertzahn (2)
Authors Affiliations(s): (1) UMass Memorial Medical Center, United States, (2) Kaleido Biosciences, Inc., United States
Background:
In the US, most COVID-19 cases are managed via outpatient care. However, COVID-19 disease symptomatology and time to symptom resolution in non-hospitalised patients are not well understood. Furthermore, recent studies suggest the gut microbiome may be involved in the dysfunctional immune response and disease severity of COVID-19 infections. To understand more clearly COVID-19 symptomatology and the possible role of the gut microbiome, we conducted a clinical food study in non-hospitalised patients with mild to moderate COVID-19 to observe the natural history of the disease and evaluate KB109 safety and its effects on select health measures when combined with supportive self-care (SSC) vs SSC alone. KB109, a microbiome metabolic therapy, is a novel synthetic glycan developed to support immune system homeostasis through modulation of the gut microbiome.
Methods:Adult patients were randomised 1:1 to SSC only or SSC+KB109. Randomisation was stratified by site, age subgroup, and comorbidity status. Signs and symptoms of COVID-19 and other end points were evaluated over a 35-day study period. Patients self-assessed 8 COVID-19–related cardinal symptoms; 5 additional symptoms were evaluated (13 overall symptoms).
Results:Overall, 350 patients were randomised. Interim results are presented; final study results are expected in March 2021. Interim results (SSC only, n=89; SSC+KB109, n=87) indicate that KB109 was well tolerated with no treatment-related serious adverse events. In patients reporting no comorbidities in the SSC arm, median times to resolution of the 8 cardinal and 13 overall symptoms were 12 and 14 days, respectively. In patients reporting ≥1 comorbidity, median times to resolution of the 8 cardinal symptoms with SSC only vs SSC+KB109 were 27 vs 15 days, respectively (HR=2.04 [1.03, 4.04]). Median times to resolution of the 13 cardinal symptoms in patients reporting ≥1 comorbidity with SSC only vs SSC+KB109 were 27 vs 18 days, respectively (HR=1.49 [0.77, 2.92]). The most common comorbidities reported overall were hypertension (19.3%) and chronic lung disease (9.1%).
Conclusions:Interim results from our study show that patients with ≥1 comorbidity had a longer duration of COVID-19 symptoms and encouraging data indicates that the addition of KB109 to SSC may improve time to resolution of symptoms in this patient population.
Keyword(s): COVID-19, comorbidity, KB109COI Other: Study funding provided by Kaleido Biosciences, Inc.
Session Type: ePosters
Session Title: ePosters
Authors(s): J. Haran (1), Y. Zheng (2), N. Alonzo-Palma (2), M. Wingertzahn (2)
Authors Affiliations(s): (1) UMass Memorial Medical Center, United States, (2) Kaleido Biosciences, Inc., United States
Background:
In the US, most COVID-19 cases are managed via outpatient care. However, COVID-19 disease symptomatology and time to symptom resolution in non-hospitalised patients are not well understood. Furthermore, recent studies suggest the gut microbiome may be involved in the dysfunctional immune response and disease severity of COVID-19 infections. To understand more clearly COVID-19 symptomatology and the possible role of the gut microbiome, we conducted a clinical food study in non-hospitalised patients with mild to moderate COVID-19 to observe the natural history of the disease and evaluate KB109 safety and its effects on select health measures when combined with supportive self-care (SSC) vs SSC alone. KB109, a microbiome metabolic therapy, is a novel synthetic glycan developed to support immune system homeostasis through modulation of the gut microbiome.
Methods:Adult patients were randomised 1:1 to SSC only or SSC+KB109. Randomisation was stratified by site, age subgroup, and comorbidity status. Signs and symptoms of COVID-19 and other end points were evaluated over a 35-day study period. Patients self-assessed 8 COVID-19–related cardinal symptoms; 5 additional symptoms were evaluated (13 overall symptoms).
Results:Overall, 350 patients were randomised. Interim results are presented; final study results are expected in March 2021. Interim results (SSC only, n=89; SSC+KB109, n=87) indicate that KB109 was well tolerated with no treatment-related serious adverse events. In patients reporting no comorbidities in the SSC arm, median times to resolution of the 8 cardinal and 13 overall symptoms were 12 and 14 days, respectively. In patients reporting ≥1 comorbidity, median times to resolution of the 8 cardinal symptoms with SSC only vs SSC+KB109 were 27 vs 15 days, respectively (HR=2.04 [1.03, 4.04]). Median times to resolution of the 13 cardinal symptoms in patients reporting ≥1 comorbidity with SSC only vs SSC+KB109 were 27 vs 18 days, respectively (HR=1.49 [0.77, 2.92]). The most common comorbidities reported overall were hypertension (19.3%) and chronic lung disease (9.1%).
Conclusions:Interim results from our study show that patients with ≥1 comorbidity had a longer duration of COVID-19 symptoms and encouraging data indicates that the addition of KB109 to SSC may improve time to resolution of symptoms in this patient population.
Keyword(s): COVID-19, comorbidity, KB109COI Other: Study funding provided by Kaleido Biosciences, Inc.