Who is sponsoring NCT04486482?

NCT04486482 is sponsored by Kaleido Biosciences.

What drugs are being tested in NCT04486482?

Interventions in NCT04486482: KB109 + Self Supportive Care (SSC), Self Supportive Care (SSC) Alone.

What condition does NCT04486482 study?

NCT04486482 studies Mild-to-Moderate COVID-19.

Is NCT04486482 still recruiting?

NCT04486482 is currently completed. Last updated 13 August 2021.

Last reviewed 2021-08-13 · How we verify

NCT04486482

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function

Completed NA Last updated 13 August 2021

What this trial tests

NA trial testing KB109 + Self Supportive Care (SSC) in Mild-to-Moderate COVID-19 in 49 participants. Completed in 30 March 2021.

Timeline

12 January 2021

Primary endpoint
30 March 2021

30 March 2021

Quick facts

Lead sponsor	Kaleido Biosciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	49
Start date	12 January 2021
Primary completion	30 March 2021
Estimated completion	30 March 2021
Sites	12 locations across United States

Drugs / interventions tested

KB109 + Self Supportive Care (SSC)
Self Supportive Care (SSC) Alone

Conditions studied

Mild-to-Moderate COVID-19 — all drugs for Mild-to-Moderate COVID-19 →

Sponsor

Kaleido Biosciences — full company profile →

Who can join

18 and older, any sex, with Mild-to-Moderate COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Lost microbes of COVID-19: <i>Bifidobacterium</i>, <i>Faecalibacterium</i> depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity.
Hazan S, Stollman N, Bozkurt HS, Dave S, et al · · 2022 · cited 66× · PMID 35483736 · DOI 10.1136/bmjgast-2022-000871
Role of Gut Microbiome in COVID-19: An Insight Into Pathogenesis and Therapeutic Potential.
Hussain I, Cher GLY, Abid MA, Abid MB. · · 2021 · cited 53× · PMID 34721437 · DOI 10.3389/fimmu.2021.765965
Gut Microbiota Dysbiosis-Immune Hyperresponse-Inflammation Triad in Coronavirus Disease 2019 (COVID-19): Impact of Pharmacological and Nutraceutical Approaches.
Ferreira C, Viana SD, Reis F. · · 2020 · cited 44× · PMID 33019592 · DOI 10.3390/microorganisms8101514
Altered gut microbiota patterns in COVID-19: Markers for inflammation and disease severity.
Chakraborty C, Sharma AR, Bhattacharya M, Dhama K, et al · · 2022 · cited 24× · PMID 35978881 · DOI 10.3748/wjg.v28.i25.2802
Targeting the Gut Microbiota in Coronavirus Disease 2019: Hype or Hope?
Lau HC, Ng SC, Yu J. · · 2022 · cited 16× · PMID 34508775 · DOI 10.1053/j.gastro.2021.09.009
Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gu
Haran JP, Pinero JC, Zheng Y, Palma NA, et al · · 2021 · cited 7× · PMID 33810796 · DOI 10.1186/s13063-021-05157-0
Impending Mental Health Issues During Coronavirus Disease 2019 - Time for Personalized Nutrition Based on the Gut Microbiota to Tide Over the Crisis?
Dhar D. · · 2021 · cited 3× · PMID 35110993 · DOI 10.3389/fnins.2021.831193
The lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity
Hazan S, Stollman N, Bozkurt H, Dave S, et al · · 2021 · DOI 10.1101/2021.09.02.21262832

Verify or expand the search:

Other trials of KB109 + Self Supportive Care (SSC)

Trials testing the same drug.

NCT04414124 — A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients · NA · completed

Other Kaleido Biosciences trials

Trials by the same sponsor.

NCT04814914 — An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or · completed
NCT04508413 — A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and · NA · completed
NCT04414124 — A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients · NA · completed
NCT03933410 — UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder · Phase 2 · terminated
NCT03944369 — VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts A · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04486482 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kaleido Biosciences
Last refreshed: 13 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04486482.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing