COVID-19NCT04814914
An Observational Clinical Study to Evaluate COVID-19 Symptoms in "Long Hauler" Patients Who Participated in K031-120 or K032-120
An observational study of COVID-19, run by Kaleido Biosciences at 2 sites in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- KB109 + Self Supportive Care and Self Supportive Care (SSC) Alone
- How many people
- 333 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2021to 28 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who participated in K031-120 or K032-120 study.
Who may be able to join
- Have consented to participate over the telephone
- Have been randomized in either the K031-120 or K032-120 study
Who cannot join
- Have withdrawn consent from K031-120 or K032-120
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Quad Clinical Research
Chicago, Illinois, 60643
HealthStar Research, LLC
Hot Springs, Arkansas, 71913
About this study
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")
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").
- Conditions
- COVID-19
- Being tested
- KB109 + Self Supportive Care, Self Supportive Care (SSC) Alone
- Keywords
- 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
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB109 + Self Supportive CareOther
KB109 is a novel glycan
Self Supportive Care (SSC) AloneOther
Self Supportive Care (SSC) Alone
| Study group | Role | What they receive |
|---|---|---|
| KB109 + Self Supportive Care (SSC) | Not described Receives: Other: KB109 + Self Supportive Care | |
| Self Supportive Care (SSC) Alone | Not described Receives: Other: Self Supportive Care (SSC) Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with persistent COVID-19 symptoms for at least 12-weeks post-randomization in K031-120 or K032-120 study.
Measured: 12-weeks from randomization in K031-120 or K032-120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start25 Mar 2021
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaleido Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Wingertzahn, PhD, Study director, Kaleido Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814914
- Sponsor's protocol ID
- K034-120
- Status last verified
- Aug 2021
- First submitted
- 23 Mar 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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")
- ClinicalTrials.gov ID
- NCT04814914
- Acronym / sponsor ID
- K034-120
- Conditions
- COVID-19
- Keywords
- Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KB109 + Self Supportive Care (SSC) | – | Other: KB109 + Self Supportive Care |
| Self Supportive Care (SSC) Alone | – | Other: Self Supportive Care (SSC) Alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in K031-120 or K032-120 study.
Key inclusion criteria (2 listed)
- Have consented to participate over the telephone
- Have been randomized in either the K031-120 or K032-120 study
Key exclusion criteria (1 listed)
- Have withdrawn consent from K031-120 or K032-120
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB109 + Self Supportive CareKB109 is a novel glycan | Other | KB109 + Self Supportive Care (SSC) |
| Self Supportive Care (SSC) AloneSelf Supportive Care (SSC) Alone | Other | Self Supportive Care (SSC) Alone |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Wingertzahn, PhD study director
Kaleido Biosciences, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Kaleido Biosciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.