Who is sponsoring NCT04414124?

NCT04414124 is sponsored by Kaleido Biosciences.

What drugs are being tested in NCT04414124?

Interventions in NCT04414124: KB109 + Self Supportive Care (SSC), Self Supportive Care (SSC) Alone.

What condition does NCT04414124 study?

NCT04414124 studies Mild-to-moderate COVID-19.

Is NCT04414124 still recruiting?

NCT04414124 is currently completed. Last updated 13 August 2021.

Last reviewed 2021-08-13 · How we verify

NCT04414124

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 Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19

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 350 participants. Completed in 2 February 2021.

Timeline

2 August 2020

Primary endpoint
2 February 2021

2 February 2021

Quick facts

Lead sponsor	Kaleido Biosciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	350
Start date	2 August 2020
Primary completion	2 February 2021
Estimated completion	2 February 2021
Sites	16 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 randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19.

Publications & conference data

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

Gut Dysbiosis during COVID-19 and Potential Effect of Probiotics.
Hung YP, Lee CC, Lee JC, Tsai PJ, et al · · 2021 · cited 32× · PMID 34442684 · DOI 10.3390/microorganisms9081605
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
Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction.
Webster KE, O'Byrne L, MacKeith S, Philpott C, et al · · 2021 · cited 22× · PMID 34291812 · DOI 10.1002/14651858.cd013877.pub2
Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction.
O'Byrne L, Webster KE, MacKeith S, Philpott C, et al · · 2022 · cited 21× · PMID 36062970 · DOI 10.1002/14651858.cd013876.pub3
Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction.
O'Byrne L, Webster KE, MacKeith S, Philpott C, et al · · 2021 · cited 21× · PMID 34291813 · DOI 10.1002/14651858.cd013876.pub2
Alterations of the gut microbiota in coronavirus disease 2019 and its therapeutic potential.
Xiang H, Liu QP. · · 2022 · cited 12× · PMID 36620345 · DOI 10.3748/wjg.v28.i47.6689
Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction.
Webster KE, O'Byrne L, MacKeith S, Philpott C, et al · · 2022 · cited 11× · PMID 36063364 · DOI 10.1002/14651858.cd013877.pub3
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

Verify or expand the search:

Other trials of KB109 + Self Supportive Care (SSC)

Trials testing the same drug.

NCT04486482 — A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Fu · 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
NCT04486482 — A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Fu · NA · completed
NCT04508413 — A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and · 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 NCT04414124 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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/NCT04414124.

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