Suspected or Confirmed COVID-19Phase 2COVGUT20NCT04540406
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
A Phase 2 study testing NBT-NM108 in people with Suspected or Confirmed COVID-19, run by Notitia Biotechnologies Company at 1 site in United States.
Trial summary
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Suspected or Confirmed COVID-19
- What is being tested?
- NBT-NM108
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 14 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 to 79 (inclusive)
- Have mild to moderate COVID-19-like symptoms based on the symptom list from CDC (updated May 13, 2020) and the severity categorization from FDA [18]:
- Mild COVID-19
- Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea
- No clinical signs indicative of moderate, severe, or critical illness severity
- Moderate COVID-19
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- Symptoms of moderate illness with COVID-19 could include any symptom of mild illness or shortness of breath with exertion
- Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths/min, oxygen saturation level > 93% on room air at sea level, heart rate ≥ 90 beats/min
- No clinical signs indicative of severe or critical illness severity
- Directed to home isolation by study physician
- Confirm study enrollment within 7 days of symptom onset
- Practice acceptable contraception, i.e., continue with current methods if participants are already practicing contraception, otherwise participants must agree to practicing contraception with a barrier method (male or female condom) or abstinence, from Day 1 to Day 35 or 7 days after the last dose of NBT-NM108 if they do not complete the 28-day intervention.
- Have access to a smartphone, tablet, computer, or other qualifying internet-enabled device and daily internet access
- Understand and be able to follow written and oral instructions in English
- Provide informed consent
Who cannot join
- Have tested positive for COVID-19 and recovered
- Receiving vancomycin monotherapy or oral broad-spectrum antibiotics
- Inability to receive oral fluids
- Self-reported allergy or intolerance to any ingredients in NBT-NM108
- Surgery involving the intestinal lumen within the last 30 days
- Documented diagnosis of celiac disease, inflammatory bowel disease or irritable bowel syndrome
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- Pregnancy or breastfeeding
- Bariatric surgery
- Immunocompromised, e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS, prolonged use of steroids or other immunosuppressant medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida Morsani College of Medicine
Tampa, Florida, 33612
About this study
Official title: Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.
- Conditions
- Suspected or Confirmed COVID-19
- Being tested
- NBT-NM108, Usual Care Only
- Keywords
- COVID-19, NBT-NM108, Notitia Biotechnologies Company, Notitia Biotechnologies, Microbiome, Microbiota, Gut microbiome, Gut microbiota, Corona Virus, Novel Corona Virus, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBT-NM108Drug
Taken in the form of drinks four times a day (before each main meal and 2 hours after dinner) for 28 days. Each drink is prepared by mixing one sachet (30 g) with 500 ml of water.
Usual Care OnlyOther
Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
| Study group | Role | What they receive |
|---|---|---|
| NBT-NM108 + Usual Care | Experimental | Not described Receives: Drug: NBT-NM108 |
| Usual Care Only | Active comparator | Not described Receives: Other: Usual Care Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplicon Sequence Variants (ASVs) That Are Significantly Correlated With Variation in the Microbiome Data Between NBT-NM108 Group and Usual Care Only Group From Day 0 to 28
Amplicon Sequence Variants (ASVs) significantly correlated with the first principal coordinate (PC1) from the covariate-adjusted Principal Coordinates Analysis (aPCoA) were identified, each having an average relative abundance greater than 0.001%. These ASVs represent specific microbial features whose relative abundance was most strongly associated with the primary axis of variation in the microbiome data, after adjusting for covariates. It was hypothesized that PC1 might reflect the direction of microbiome changes induced by the intervention, given its association with shifts observed in participants' microbiome compositions before and after the intervention. The unit of measure used here is the relative abundance percentage of each ASV in the stool sample.
Measured: Day 0-28
Secondary outcomes (12)
Number of Participants That Were Hospitalized or Died From COVID19
Hospitalization or death
Measured: At days 0, 14, 28, and 56
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
(not specified)
Measured: At days 0, 14, 28, and 56
Number of Participants Who Visited the Emergency Room From COVID-19
Measured: At days 0, 14, 28, and 56
Proportion of Participants Who Have Complete Resolution of Objective Symptoms
All vitals signs are within normal range for at least 24h, including body temperature 36.4-37.5C (97.7-99.5F), pulse rate <90/min, respiratory rate 12-16/min, and oxygen saturation level at 95-100%.
Measured: At days 28 and 56
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms
Absence of all COVID-19-like symptoms listed by CDC (updated May 13, 2020) for at least 48h, including the presence of chills or "feeling feverish" , cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea
Measured: At days 28 and 56
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough
Proportion of participants who have complete resolution of subjective symptoms except fatigue and cough, i.e. absence of all COVID-19-like symptoms listed by CDC (updated May 13, 2020) for at least 48 h, including the presence of chills or "feeling feverish", cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting and diarrhea
Measured: At days 28 and 56
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
Proportion of participants who meet each COVID-19 category in both mild, moderate, and severe categories
Measured: Day 0
Oral Body Temperature (F)
Measured: At days 0, 14, 28, and 56
Oxygen Saturation SpO2 Level
Measured: At days 0, 14, 28, and 56
Pulse Rate Per Minute
Measured: At days 0, 14, 28, and 56
Respiratory Rate Per Minute
Measured: At days 0, 14, 28, and 56
Fasting Blood Glucose
Measured: At days 0 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start2 Nov 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suspected or Confirmed 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notitia Biotechnologies Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida, Rutgers University
- Responsible party
- Sponsor
- Investigators
- Asa Oxner, MD, Principal investigator, University of South FloridaLiping Zhao, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540406
- Sponsor's protocol ID
- NBTNM10810012020
- Acronym
- COVGUT20
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2020
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04540406
- Acronym / sponsor ID
- COVGUT20 / NBTNM10810012020
- Conditions
- Suspected or Confirmed COVID-19
- Keywords
- COVID-19, NBT-NM108, Notitia Biotechnologies Company, Notitia Biotechnologies, Microbiome, Microbiota, Gut microbiome, Gut microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Notitia Biotechnologies CompanyIndustry (pharma, biotech, devices)
- Collaborators
- University of South Florida, Rutgers University
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBT-NM108 + Usual Care | Experimental | Drug: NBT-NM108 |
| Usual Care Only | Active comparator | Other: Usual Care Only |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged between 18 to 79 (inclusive)
- Have mild to moderate COVID-19-like symptoms based on the symptom list from CDC (updated May 13, 2020) and the severity categorization from FDA [18]:
- Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea
- No clinical signs indicative of moderate, severe, or critical illness severity
- Symptoms of moderate illness with COVID-19 could include any symptom of mild illness or shortness of breath with exertion
Key exclusion criteria (9 listed)
- Have tested positive for COVID-19 and recovered
- Receiving vancomycin monotherapy or oral broad-spectrum antibiotics
- Inability to receive oral fluids
- Self-reported allergy or intolerance to any ingredients in NBT-NM108
- Surgery involving the intestinal lumen within the last 30 days
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 |
|---|---|---|
| NBT-NM108Taken in the form of drinks four times a day (before each main meal and 2 hours after dinner) for 28 days. Each drink is prepared by mixing one sachet (30 g) with 500 ml of water. | Drug | NBT-NM108 + Usual Care |
| Usual Care OnlyControl group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. | Other | Usual Care Only |
Primary outcome
Amplicon Sequence Variants (ASVs) That Are Significantly Correlated With Variation in the Microbiome Data Between NBT-NM108 Group and Usual Care Only Group From Day 0 to 28
Time frame: Day 0-28
Amplicon Sequence Variants (ASVs) significantly correlated with the first principal coordinate (PC1) from the covariate-adjusted Principal Coordinates Analysis (aPCoA) were identified, each having an average relative abundance greater than 0.001%. These ASVs represent specific microbial features whose relative abundance was most strongly associated with the primary axis of variation in the microbiome data, after adjusting for covariates. It was hypothesized that PC1 might reflect the direction of microbiome changes induced by the intervention, given its association with shifts observed in participants' microbiome compositions before and after the intervention. The unit of measure used here is the relative abundance percentage of each ASV in the stool sample.
12 secondary outcomes
Number of Participants That Were Hospitalized or Died From COVID19
Time frame: At days 0, 14, 28, and 56
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
Time frame: At days 0, 14, 28, and 56
Number of Participants Who Visited the Emergency Room From COVID-19
Time frame: At days 0, 14, 28, and 56
Proportion of Participants Who Have Complete Resolution of Objective Symptoms
Time frame: At days 28 and 56
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms
Time frame: At days 28 and 56
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough
Time frame: At days 28 and 56
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
Time frame: Day 0
Oral Body Temperature (F)
Time frame: At days 0, 14, 28, and 56
Oxygen Saturation SpO2 Level
Time frame: At days 0, 14, 28, and 56
Pulse Rate Per Minute
Time frame: At days 0, 14, 28, and 56
Respiratory Rate Per Minute
Time frame: At days 0, 14, 28, and 56
Fasting Blood Glucose
Time frame: At days 0 and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Suspected or Confirmed COVID-19
Active, not recruitingObservational study
Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia
COVID 19
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.
Asa Oxner, MD principal investigator
University of South Florida
Liping Zhao, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBT-NM108 in people with Suspected or Confirmed COVID-19, run by Notitia Biotechnologies Company at 1 site 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 15 inclusion and 9 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amplicon Sequence Variants (ASVs) That Are Significantly Correlated With Variation in the Microbiome Data Between NBT-NM108 Group and Usual Care Only Group From Day 0 to 28 (time frame: Day 0-28). 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 8 Oct 2024.