Back to resultsNBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients (COVGUT20)
Primary Purpose
Suspected or Confirmed COVID-19
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NBT-NM108
Usual Care Only
Sponsored by
About this trial
This is an interventional treatment trial for Suspected or Confirmed COVID-19 focused on measuring COVID-19, NBT-NM108, Notitia Biotechnologies Company, Notitia Biotechnologies, Microbiome, Microbiota, Gut microbiome, Gut microbiota, Corona Virus, Novel Corona Virus, SARS-CoV-2
Eligibility Criteria
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
- 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
- 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
Sites / Locations
- University of South Florida Morsani College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NBT-NM108 + Usual Care
Usual Care Only
Arm Description
Outcomes
Primary Outcome Measures
Gut Microbiota Composition
Secondary Outcome Measures
Outcome of COVID-19 related illnesses
Discontinuation of home isolation status
Outcome of COVID-19 related illnesses
Hospitalization status
Outcome of COVID-19 related illnesses
Deaths
Proportion of participants who are "alive and not admitted to the hospital"
Proportion of participants who visit the emergency room
Proportion of participants who have complete resolution of all objective symptoms
All vital signs are within the normal range for at least 24 h, including body temperature 36.5-37.5°C (97.7-99.5°F), pulse rate <90/min, respiratory rate 12-16/min and oxygen saturation level at 95-100%
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 24 h, including 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
Illness severity based on the categorization from FDA COVID-19 Guidance Document
Illness severity based the Ordinal Scale for Clinical Improvement from the World Health Organization
Body temperature (F)
Oxygen saturation SpO2 level
Pulse rate per minute
Respiratory rate per minute
Fasting blood glucose (mg/dl)
Full Information
NCT ID
NCT04540406
First Posted
September 3, 2020
Last Updated
June 9, 2022
Sponsor
Notitia Biotechnologies Company
Collaborators
University of South Florida, Rutgers University
1. Study Identification
Unique Protocol Identification Number
NCT04540406
Brief Title
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Acronym
COVGUT20
Official Title
Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Notitia Biotechnologies Company
Collaborators
University of South Florida, Rutgers University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected or Confirmed COVID-19
Keywords
COVID-19, NBT-NM108, Notitia Biotechnologies Company, Notitia Biotechnologies, Microbiome, Microbiota, Gut microbiome, Gut microbiota, Corona Virus, Novel Corona Virus, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBT-NM108 + Usual Care
Arm Type
Experimental
Arm Title
Usual Care Only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
NBT-NM108
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Only
Intervention Description
Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
Primary Outcome Measure Information:
Title
Gut Microbiota Composition
Time Frame
Day 0 to 56
Secondary Outcome Measure Information:
Title
Outcome of COVID-19 related illnesses
Description
Discontinuation of home isolation status
Time Frame
At days 0, 14, 28, and 56
Title
Outcome of COVID-19 related illnesses
Description
Hospitalization status
Time Frame
At days 0, 14, 28, and 56
Title
Outcome of COVID-19 related illnesses
Description
Deaths
Time Frame
At days 0, 14, 28, and 56
Title
Proportion of participants who are "alive and not admitted to the hospital"
Time Frame
At days 0, 14, 28, and 56
Title
Proportion of participants who visit the emergency room
Time Frame
At days 0, 14, 28, and 56
Title
Proportion of participants who have complete resolution of all objective symptoms
Description
All vital signs are within the normal range for at least 24 h, including body temperature 36.5-37.5°C (97.7-99.5°F), pulse rate <90/min, respiratory rate 12-16/min and oxygen saturation level at 95-100%
Time Frame
At days 0, 14, 28, and 56
Title
Proportion of participants who have complete resolution of subjective symptoms
Description
Absence of all COVID-19-like symptoms listed by CDC (updated May 13, 2020) for at least 24 h, including 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
Time Frame
At days 0, 14, 28, and 56
Title
Illness severity based on the categorization from FDA COVID-19 Guidance Document
Time Frame
At days 0, 14, 28, and 56
Title
Illness severity based the Ordinal Scale for Clinical Improvement from the World Health Organization
Time Frame
At days 0, 14, 28, and 56
Title
Body temperature (F)
Time Frame
At days 0, 14, 28, and 56
Title
Oxygen saturation SpO2 level
Time Frame
At days 0, 14, 28, and 56
Title
Pulse rate per minute
Time Frame
At days 0, 14, 28, and 56
Title
Respiratory rate per minute
Time Frame
At days 0, 14, 28, and 56
Title
Fasting blood glucose (mg/dl)
Time Frame
At days 0, 14, 28, and 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asa Oxner, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liping Zhao, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida Morsani College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
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