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

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ClinicalTrials.gov Identifier: NCT04814914
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

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
COVID-19 Other: KB109 + Self Supportive Care Other: Self Supportive Care (SSC) Alone

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Study Type : Observational
Estimated Enrollment : 300 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")
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : August 2021

Group/Cohort 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




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. [ Time Frame: 12-weeks from randomization in K031-120 or K032-120 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who participated in K031-120 or K032-120 study.
Criteria

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  • Have withdrawn consent from K031-120 or K032-120

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814914


Contacts
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Contact: Mark Wingertzahn, PhD (617) 674-9000 clinicalstudies@kaleido.com

Locations
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United States, Arkansas
HealthStar Research, LLC Recruiting
Hot Springs, Arkansas, United States, 71913
United States, Illinois
Quad Clinical Research Recruiting
Chicago, Illinois, United States, 60643
Sponsors and Collaborators
Kaleido Biosciences
Investigators
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Study Director: Mark Wingertzahn, PhD Kaleido Biosciences, Inc.
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Responsible Party: Kaleido Biosciences
ClinicalTrials.gov Identifier: NCT04814914    
Other Study ID Numbers: K034-120
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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