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| Name | Class |
|---|---|
| University of South Florida | OTHER |
| Rutgers University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBT-NM108 + Usual Care | Experimental |
| |
| Usual Care Only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBT-NM108 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Were Hospitalized or Died From COVID19 | Hospitalization or death | At days 0, 14, 28, and 56 |
| Proportion of Participants Who Are "Alive and Not Admitted to the Hospital" |
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Inclusion Criteria:
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]:
a) 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
b) Moderate COVID-19
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
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Asa Oxner, MD | University of South Florida | Principal Investigator |
| Liping Zhao, PhD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida Morsani College of Medicine | Tampa | Florida | 33612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NBT-NM108 + Usual Care | NBT-NM108: 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. |
| FG001 | Usual Care Only | Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NBT-NM108 + Usual Care | NBT-NM108: 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. |
| BG001 | Usual Care Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage | Day 0-28 |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NBT-NM108 + Usual Care | NBT-NM108: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild adverse events | General disorders | Systematic Assessment | mild adverse events include bloating, abdominal discomfort, and Pruritus |
The primary limitation of our randomized controlled trial is the restriction of our study population to patients with mild to moderate COVID-19. Consequently, the findings may not be generalizable to individuals with severe or critical COVID-19.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Notitia Biotechnologies | 732-230-3175 | ciarra.williams@notitiabio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2022 | Jun 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2024 | Jun 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Usual Care Only | Other | Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. |
|
(not specified)
| At days 0, 14, 28, and 56 |
| Number of Participants Who Visited the Emergency Room From COVID-19 | 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%. | 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 | 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 | 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 | Day 0 |
| Oral Body Temperature (F) | At days 0, 14, 28, and 56 |
| Oxygen Saturation SpO2 Level | At days 0, 14, 28, and 56 |
| Pulse Rate Per Minute | At days 0, 14, 28, and 56 |
| Respiratory Rate Per Minute | At days 0, 14, 28, and 56 |
| Fasting Blood Glucose | At days 0 and 28 |
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
NBT-NM108: 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. |
| OG001 | Usual Care Only (Day 0) | Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. |
| OG002 | NBT-NM108 + Usual Care (Day 28) | NBT-NM108: 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. |
| OG003 | Usual Care Only (Day 28) | Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. |
|
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| Secondary | Number of Participants That Were Hospitalized or Died From COVID19 | Hospitalization or death | Posted | Count of Participants | Participants | At days 0, 14, 28, and 56 |
|
|
|
| Secondary | Proportion of Participants Who Are "Alive and Not Admitted to the Hospital" | (not specified) | Posted | Count of Participants | Participants | At days 0, 14, 28, and 56 |
|
|
|
| Secondary | Number of Participants Who Visited the Emergency Room From COVID-19 | Posted | Count of Participants | Participants | At days 0, 14, 28, and 56 |
|
|
|
| Secondary | 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%. | Posted | Count of Participants | Participants | At days 28 and 56 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | At days 28 and 56 |
|
|
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| Secondary | 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 | Posted | Count of Participants | Participants | At days 28 and 56 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Day 0 |
|
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| Secondary | Oral Body Temperature (F) | Posted | Mean | Standard Deviation | Degrees Fahrenheit (F) | At days 0, 14, 28, and 56 |
|
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| Secondary | Oxygen Saturation SpO2 Level | Posted | Mean | Standard Deviation | percentage of oxygen saturation | At days 0, 14, 28, and 56 |
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| Secondary | Pulse Rate Per Minute | Posted | Mean | Standard Deviation | beats per minute | At days 0, 14, 28, and 56 |
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| Secondary | Respiratory Rate Per Minute | Posted | Mean | Standard Deviation | breaths per minute | At days 0, 14, 28, and 56 |
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| Secondary | Fasting Blood Glucose | Posted | Mean | Standard Deviation | mg/dL | At days 0 and 28 |
|
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| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Usual Care Only | Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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