Mild-to-moderate COVID-19NCT04414124
A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19
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 16 sites in United States.
Trial summary
This randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19. 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
- 350 participants
- Where
- 16 sitesUnited States
- Study dates
- 2 Aug 2020to 2 Feb 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
Who may be able to join
- 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.
Who cannot join
- 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
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Mount Vernon Clinical Research
Atlanta, Georgia, 30328
ClinSearch LLC
Chattanooga, Tennessee, 37421
Global Medical Research
DeSoto, Texas, 75115
TruCare Internal Medicine and Infectious Diseases
DuBois, Pennsylvania, 15801
Carolina Institute For Clinical Research
Fayetteville, North Carolina, 28304
Healthstar Research
Hot Springs, Arkansas, 71913
Centex Studies
Houston, Texas, 77058
Centex Studies, Inc. - Lake Charles
Lake Charles, Louisiana, 70601
Wake Research - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, 89104
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501
Vista Health Research
Miami, Florida, 33176
Bio-Medical Research
Miami, Florida, 33184
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
Axon Clinical Research
Riverside, California, 92505
Medical Center for Clinical Research
San Diego, California, 92108
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19
This randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19.
- 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, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Supportive Self Care, SSC, 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 (7)
Change from baseline to end of intake in overall composite COVID-19 symptom score
The composite COVID-19 symptom score is the sum of the 8 cardinal COVID-19 related symptom scores (cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild: Moderately severe. The overall composite score ranges from 0 (no symptoms) to 24 (very severe)
Measured: Day 1 to Day 35
Time to resolution of fever
Resolution of fever is defined as from Day 1 until the day at which a patient's daily maximum temperature achieves and remains below 100.4 Degrees Fahrenheit for the rest of the intake period and for the follow-up period without an antipyretic medication.
Measured: Day 1 to Day 35
Proportion of patients with decreased oxygen saturation
Measured: Day 14, Day 35
Effect of COVID-19 symptoms on physical activities
Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.
Measured: Day 1 to Day 35
Proportion of patients requiring hospitalization
Measured: Day 1 to Day 35
Time to resolution of overall 13 COVID-19 related symptoms.
Defined as from Day 1 until the day at which the overall composite score of 13 COVID-19 related symptoms becomes 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 13 COVID-19 related symptoms is the sum of 13 COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal disturbance/symptoms, diarrhea, fatigue, nasal congestion, and chest tightness (CDC 2020). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe. The overall composite score ranges from 0 (no symptoms) to 39 (very severe).
Measured: Day 1 to Day 35
Time to resolution of overall 8 cardinal COVID-19 related symptoms.
Defined as from Day 1 until the day at which the overall composite score of 8 cardinal COVID-19 related symptoms 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 8 cardinal COVID-19 related symptoms is the sum of 8 cardinal COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat).
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 posted4 Jun 2020
- Study start2 Aug 2020
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 350 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
- NCT04414124
- Sponsor's protocol ID
- K031-120
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04414124
- Acronym / sponsor ID
- K031-120
- Conditions
- Mild-to-moderate COVID-19
- Keywords
- Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Kaleido BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 4 Jun 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 randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19.
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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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
7 secondary outcomes
Change from baseline to end of intake in overall composite COVID-19 symptom score
Time frame: Day 1 to Day 35
Time to resolution of fever
Time frame: Day 1 to Day 35
Proportion of patients with decreased oxygen saturation
Time frame: Day 14, Day 35
Effect of COVID-19 symptoms on physical activities
Time frame: Day 1 to Day 35
Proportion of patients requiring hospitalization
Time frame: Day 1 to Day 35
Time to resolution of overall 13 COVID-19 related symptoms.
Time frame: Day 1 to Day 35
Time to resolution of overall 8 cardinal COVID-19 related symptoms.
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.
Related trials for Mild-to-moderate COVID-19
Not yet recruitingPhase 1/2
Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms
COVID-19
RecruitingPhase 1/2
SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease
Covid19
Recruiting
Local Thermotherapy for Patients With Mild-to-moderate COVID-19
COVID-19, Thermotherapy
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
16 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 16 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 6 inclusion and 7 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 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 16 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?
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.