An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120

• Sponsor: Kaleido Biosciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04814914
• Collaborator: (none)
• Enrollment: 333
• Locations: 2
• Actual Duration (Months): 2.1
• Patients Per Site: 166.5
• Patients Per Site Per Month: 79.2

Study Details

Study Description

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").

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Other: KB109 + Self Supportive Care; Other: Self Supportive Care (SSC) Alone

Study Design

• Study Type: Observational
• Actual Enrollment: 333 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Observational Study to Evaluate the Presence of Symptoms After COVID-19 Infection in Patients Who Participated in K031-120 or K032-120 Study ("Long Hauler")
• Actual Study Start Date: Mar 25, 2021
• Actual Primary Completion Date: May 28, 2021
• Actual Study Completion Date: May 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
KB109 + Self Supportive Care (SSC)	Other: KB109 + Self Supportive Care; KB109 is a novel glycan
Self Supportive Care (SSC) Alone	Other: Self Supportive Care (SSC) Alone; Self Supportive Care (SSC) Alone

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Have consented to participate over the telephone

• Have been randomized in either the K031-120 or K032-120 study

Exclusion Criteria:

• Have withdrawn consent from K031-120 or K032-120

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HealthStar Research, LLC	Hot Springs	Arkansas	United States	71913
2	Quad Clinical Research	Chicago	Illinois	United States	60643

Sponsors and Collaborators

• Kaleido Biosciences

Investigators

• Study Director: Mark Wingertzahn, PhD, Kaleido Biosciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaleido Biosciences
• ClinicalTrials.gov Identifier: NCT04814914
• Other Study ID Numbers: K034-120
• First Posted: Mar 24, 2021
• Last Update Posted: Aug 18, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaleido Biosciences: Microbiome; COVID-19; Corona Virus; Corona Virus Disease; Kaleido; Kaleido Biosciences; KB109; Oligosaccharide; Glycan; Microbiome metabolic therapy; MMT; Supportive Self Care; SSC; Telemedicine; K031-120; K032-120
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 18, 2021