Mild-to-Moderate COVID-19NCT04486482
A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
A study testing KB109 + Self Supportive Care (SSC) and Self Supportive Care (SSC) Alone in people with Mild-to-Moderate COVID-19, run by Kaleido Biosciences at 12 sites in United States.
Trial summary
This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild-to-Moderate COVID-19
- What is being tested?
- KB109 + Self Supportive Care (SSC) and Self Supportive Care (SSC) Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 12 sitesUnited States
- Study dates
- 12 Jan 2021to 30 Mar 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
To be considered for enrollment into this study, each patient must meet all of the following Inclusion Criteria:
- Be male or female, ≥18 years of age
- Be willing and able to give informed consent
- Screening/Randomization telemedicine visit within 2 days of testing positive test for COVID-19
- Having self-reported fever or cough for not more than 72 hours prior to COVID-19 testing
- Mild to moderate COVID-19
- Able to adhere to the study visit schedule and other protocol requirements
Patients who meet any of the following Exclusion Criteria at the Randomization Visit will not be enrolled into the study:
- Patients who are hospitalized for in-patient treatment or currently being evaluated for potential hospitalization at the time of informed consent for conditions other than COVID-19
- History of chronic lung disease
- Ongoing requirement for oxygen therapy
- Shortness of breath in resting position
- Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) / Continuous Positive Airway Pressure (CPAP)
- Female patients who are pregnant, trying to become pregnant or lactating.
- Is considered, in the opinion of the PI, to be unlikely for any reason to be able to comply with study procedures
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Inquest Research
Baytown, Texas, 77521
Next Phase Research Alliance
Boca Raton, Florida, 33166
Massachusetts General Hospital
Boston, Massachusetts, 02114
Quad Clinical Research
Chicago, Illinois, 60605
Cullman Clinical Trials
Cullman, Alabama, 35055
American Institute of Research
Los Angeles, California, 90017
Advanced Pharma CR, LLC
Miami, Florida, 33147
Hope Clinical Trials
Miami, Florida, 33165
Kendall South Medical Center, Inc.
Miami, Florida, 33185
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730
Olympus Family Medicine
Salt Lake City, Utah, 84117
South Ogden Family Medicine Center
South Ogden, Utah, 84405
About this study
Official title: An Exploratory, Open Label, Clinical Study to Evaluate the Physiologic Effects of KB109 in Adult Patients With Mild-to-Moderate COVID-19 on Gut Microbiota Structure and Function in the Outpatient Setting
This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.
- Conditions
- Mild-to-Moderate COVID-19
- Being tested
- KB109 + Self Supportive Care (SSC), Self Supportive Care (SSC) Alone
- Keywords
- Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharides, Glycan, Outpatient, Pathogens, Microbiome Metabolic Therapy, MMT, Telemedicine
- 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 Care (SSC)Other
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) | Other | Not described Receives: Other: KB109 + Self Supportive Care (SSC) |
| Self Supportive Care (SSC) Alone | Other | 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.
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
Measured: Day 1 to Day 35
Secondary outcomes (1)
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.
Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone
Measured: Day 1 to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start12 Jan 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild-to-Moderate 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486482
- Sponsor's protocol ID
- K032-120
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haran JP, Pinero JC, Zheng Y, Palma NA, Wingertzahn M. Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study. Trials. 2021 Apr 2;22(1):245. doi: 10.1186/s13063-021-05157-0.
PubMed 33810796
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Open Label, Clinical Study to Evaluate the Physiologic Effects of KB109 in Adult Patients With Mild-to-Moderate COVID-19 on Gut Microbiota Structure and Function in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT04486482
- Acronym / sponsor ID
- K032-120
- Conditions
- Mild-to-Moderate COVID-19
- Keywords
- Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 24 Jul 2020 (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 exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KB109 + Self Supportive Care (SSC) | Other | Other: KB109 + Self Supportive Care (SSC) |
| Self Supportive Care (SSC) Alone | Other | Other: Self Supportive Care (SSC) Alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Care (SSC)KB109 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
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to Day 35
1 secondary outcome
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.
Time frame: Day 1 to Day 35
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 13 Aug 2021.
- Derived from this study: PubMed 33810796Haran JP, Pinero JC, Zheng Y, Palma NA, Wingertzahn M. Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study. Trials. 2021 Apr 2;22(1):245. doi: 10.1186/s13063-021-05157-0.
- 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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KB109 + Self Supportive Care (SSC) and Self Supportive Care (SSC) Alone in people with Mild-to-Moderate COVID-19, run by Kaleido Biosciences at 12 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?
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 13 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 12 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?
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) (time frame: Day 1 to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486482, which also lists 1 linked publication.
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 13 Aug 2021.