NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients

Conditions
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Suspected or Confirmed COVID-19

Intervention / Treatment
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* Drug: NBT-NM108
* Other: Usual Care Only


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBT-NM108 + Usual Care<br> | Drug: NBT-NM108<br>* 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.<br>|
| Active Comparator: Usual Care Only<br> | Other: Usual Care Only<br>* Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Microbiota Composition |  | Day 0 to 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of COVID-19 related illnesses | Discontinuation of home isolation status | At days 0, 14, 28, and 56 | 
| Outcome of COVID-19 related illnesses | Hospitalization status | At days 0, 14, 28, and 56 | 
| Outcome of COVID-19 related illnesses | Deaths | At days 0, 14, 28, and 56 | 
| Proportion of participants who are alive and not admitted to the hospital |  | At days 0, 14, 28, and 56 | 
| Proportion of participants who visit the emergency room |  | At days 0, 14, 28, and 56 | 
| 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% | At days 0, 14, 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 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 | At days 0, 14, 28, and 56 | 
| Illness severity based on the categorization from FDA COVID-19 Guidance Document |  | At days 0, 14, 28, and 56 | 
| Illness severity based the Ordinal Scale for Clinical Improvement from the World Health Organization |  | At days 0, 14, 28, and 56 | 
| 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 (mg/dl) |  | At days 0, 14, 28, and 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, NBT-NM108, Notitia Biotechnologies Company, Notitia Biotechnologies, Microbiome, Microbiota, Gut microbiome, Gut microbiota, Corona Virus, Novel Corona Virus, SARS-CoV-2