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0 0.5 1 1.5 2+ Mortality 67% Improvement Relative Risk Hospitalization 60% Hospitalization/ER/urgent.. 50% Time to resolution of sy.. 20% Probiotics  Haran et al.  EARLY TREATMENT  RCT Is early treatment with probiotics beneficial for COVID-19? RCT 350 patients in the USA (July - December 2020) Lower hospitalization (p=0.45) and fewer hosp./ER visits (p=0.13), not sig. Haran et al., medRxiv, March 2021 Favors probiotics Favors control

Targeting the Microbiome With KB109 in Outpatients with Mild to Moderate COVID-19 Reduced Medically Attended Acute Care Visits and Improved Symptom Duration in Patients With Comorbidities

Mar 2021  
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RCT 350 COVID+ outpatients in the USA, 174 treated with prebiotic KB109 (a microbiome metabolic therapy candidate), showing lower combined hospitalization, ER, and urgent care visits with treatment. NCT04414124 (history).
The immune effects of probiotics are strain-specific.
Although the 67% lower mortality is not statistically significant, it is consistent with the significant 61% lower mortality [37‑76%] from meta analysis of the 8 mortality results to date.
risk of death, 66.5% lower, RR 0.33, p = 1.00, treatment 0 of 174 (0.0%), control 1 of 176 (0.6%), NNT 176, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), death two weeks after study withdrawal.
risk of hospitalization, 59.5% lower, RR 0.40, p = 0.45, treatment 2 of 174 (1.1%), control 5 of 176 (2.8%), NNT 59, including treatment period.
risk of hospitalization/ER/urgent care, 50.0% lower, RR 0.50, p = 0.13, treatment 7 of 169 (4.1%), control 15 of 181 (8.3%), NNT 24.
time to resolution of symptoms, 20.3% lower, relative time 0.80, p = 0.10, treatment 169, control 172, inverted to make RR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Haran et al., 29 Mar 2021, Randomized Controlled Trial, USA, preprint, 6 authors, study period 2 July, 2020 - 23 December, 2020, trial NCT04414124 (history).
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Targeting the Microbiome With KB109 in Outpatients with Mild to Moderate COVID-19 Reduced Medically Attended Acute Care Visits and Improved Symptom Duration in Patients With Comorbidities
MD, PhD John P Haran, PhD Yan Zheng, MD Katharine Knobil, PhD Norma Alonzo Palma, PhD Jonathan F Lawrence, PhD Mark A Wingertzahn
Methods Adult patients who tested positive for COVID-19 were randomized 1:1 to receive KB109 combined with SSC or SSC alone for 14 days and were then followed for an additional 21 days (35 days in total). Patients self-assessed their COVID-19-related symptoms (8 cardinal symptoms plus 5 additional symptoms) and self-reported comorbidities. The primary and secondary objectives were to evaluate the safety of KB109 plus SSC compared with that of SSC alone and to evaluate selected measures of health, respectively. Results Between July 2, 2020 and December 23, 2020, 350 patients were randomized to receive KB109 and SSC (n=174) or SSC alone (n=176). Overall, the most common comorbidities reported were hypertension (18.0% [63/350 patients]) followed by chronic lung disease (8.6% 30/350 patients). KB109 was well tolerated with most treatment-emergent adverse events being mild to moderate in severity. The administration of KB109 plus SSC reduced medically-attended visits (ie, hospitalization, emergency room visits, or urgent care visits) by 50.0% in the overall population and by 61.7% in patients with ≥1 comorbidity; in patients aged ≥45 years or with ≥1 comorbidity, medically-attended visits were reduced by 52.8%, In the SSC group, patients reporting ≥1 comorbidity had a longer median time to resolution of symptoms than those who reported no comorbidities at baseline (13 overall symptoms: 30 vs 21 days, respectively; hazard ratio [HR]=1.163 [95% CI, 0.723-1.872]; 8 cardinal symptoms: 21 vs 15 days, respectively; HR=1.283 [95% CI, 0.809-2.035]). In patients reporting ≥1 comorbidity, median time to resolution of symptoms was shorter in the KB109 plus SSC group compared with the SSC alone group . (13 overall symptoms: 30 vs 21 days, respectively; HR=1.422 [95% CI, 0.898-2.250]; 8 cardinal symptoms: 17 vs 21 days, respectively; HR=1.574 [95% CI, 0.997-2.485]). In the KB109 plus SSC group, patients aged ≥45 years or with ≥1 comorbidity had a shorter median time to resolution of symptoms compared with SSC alone (overall 13 symptoms: 21 vs 31 days; HR=1.597 [95% CI, 1.064-2.398]). Conclusions Results from our study show that KB109 is well tolerated among patients with mild to moderate COVID-19. Patients with ≥1 comorbidity had a longer duration of COVID-19 symptoms than those without comorbidities. Moreover, in patients reporting ≥1 comorbidity or aged ≥45 years (at-risk population), administration of KB109 plus SSC improved median time to resolution of COVID-19-related symptoms and reduced the rate of medically-attended visits compared with SSC alone.
Ethics Approval The authors ensure this study was conducted in full conformity with Regulations for the Protection of Competing Interest Statement JPH has nothing to disclose. YZ, KK, NAP, and MAW are employees of and hold stock in Kaleido Biosciences, Inc. JFL is an employee of Kaleido Biosciences, Inc and has patents that are relevant to this work.
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