NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients (COVGUT20)

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.

Study Overview

• Status: Completed
• Conditions: Suspected or Confirmed COVID-19
• Intervention / Treatment: Drug: NBT-NM108; Other: Usual Care Only

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida Morsani College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Notitia Biotechnologies Company
• Collaborators: University of South Florida; Rutgers University
• Investigators: Principal Investigator: Asa Oxner, MD, University of South Florida; Principal Investigator: Liping Zhao, PhD, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): March 14, 2022
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Microbiome; Microbiota; COVID-19; Gut microbiota; Gut microbiome; Corona Virus; NBT-NM108; Notitia Biotechnologies Company; Notitia Biotechnologies; Novel Corona Virus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NBTNM10810012020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No