NCT04814914

Brief Summary

This observational clinical study aims to evaluate the presence of symptoms of COVID-19 infection in patients who participated in K031-120 or K032-120 ("long hauler").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

March 23, 2021

Last Update Submit

August 17, 2021

Conditions

COVID-19

Keywords

MicrobiomeCOVID-19Corona VirusCorona Virus DiseaseKaleidoKaleido BiosciencesKB109OligosaccharideGlycanMicrobiome metabolic therapyMMTSupportive Self CareSSCTelemedicineK031-120K032-120

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with persistent COVID-19 symptoms for at least 12-weeks post-randomization in K031-120 or K032-120 study.

    12-weeks from randomization in K031-120 or K032-120

Study Arms (2)

KB109 + Self Supportive Care (SSC)

Other: KB109 + Self Supportive Care

Self Supportive Care (SSC) Alone

Other: Self Supportive Care (SSC) Alone

Interventions

KB109 + Self Supportive CareOTHER

KB109 is a novel glycan

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

Self Supportive Care (SSC) Alone

Self Supportive Care (SSC) Alone

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who participated in K031-120 or K032-120 study.

You may qualify if:

  • Have consented to participate over the telephone
  • Have been randomized in either the K031-120 or K032-120 study

You may not qualify if:

  • Have withdrawn consent from K031-120 or K032-120

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HealthStar Research, LLC

Hot Springs, Arkansas, 71913, United States

Location

Quad Clinical Research

Chicago, Illinois, 60643, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Single Person

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Mark Wingertzahn, PhD

    Kaleido Biosciences, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 24, 2021

Study Start

March 25, 2021

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)