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

August 17, 2021 updated by: Kaleido Biosciences

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")

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").

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

333

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • HealthStar Research, LLC
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Quad Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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  • Have withdrawn consent from K031-120 or K032-120

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12-weeks from randomization in K031-120 or K032-120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaleido Biosciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2021

Primary Completion (ACTUAL)

May 28, 2021

Study Completion (ACTUAL)

May 28, 2021

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K034-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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