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

NCT04540406 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NBTNM10810012020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Number of Participants That Were Hospitalized or Died From COVID19

  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

• 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

  At days 28 and 56

• Proportion of Participants Who Have Complete Resolution of Subjective Symptoms

  At days 28 and 56

Study Arms (2)

NBT-NM108 + Usual Care

EXPERIMENTAL

Drug: NBT-NM108

Usual Care Only

ACTIVE COMPARATOR

Other: Usual Care Only

Interventions

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.

NBT-NM108 + Usual Care

Usual Care Only OTHER

Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.

Usual Care Only

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Notitia Biotechnologies Company: lead
• University of South Florida: collaborator
• Rutgers University: collaborator

Study Sites (1)

University of South Florida Morsani College of Medicine

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Notitia Biotechnologies

ciarra.williams@notitiabio.com

732-230-3175

Study Officials

• Asa Oxner, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Liping Zhao, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 7, 2020
• Study Start: November 2, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)