Clinical trial NCT04540406: NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Official title: Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Notitia Biotechnologies Company
Sponsor class: INDUSTRY
Collaborators: name: University of South Florida
name: Rutgers University
First posted: 2020-09-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Day 0-28
Secondary outcomes:
measure: Number of Participants That Were Hospitalized or Died From COVID19
timeFrame: At days 0, 14, 28, and 56
measure: Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
timeFrame: At days 0, 14, 28, and 56
measure: Number of Participants Who Visited the Emergency Room From COVID-19
timeFrame: At days 0, 14, 28, and 56
measure: Proportion of Participants Who Have Complete Resolution of Objective Symptoms
timeFrame: At days 28 and 56
measure: Proportion of Participants Who Have Complete Resolution of Subjective Symptoms
timeFrame: At days 28 and 56
measure: Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough
timeFrame: At days 28 and 56
measure: Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
timeFrame: Day 0
measure: Oral Body Temperature (F)
timeFrame: At days 0, 14, 28, and 56
measure: Oxygen Saturation SpO2 Level
timeFrame: At days 0, 14, 28, and 56
measure: Pulse Rate Per Minute
timeFrame: At days 0, 14, 28, and 56
measure: Respiratory Rate Per Minute
timeFrame: At days 0, 14, 28, and 56
measure: Fasting Blood Glucose
timeFrame: At days 0 and 28
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Morsani College of Medicine
state: Florida
Study officials:
affiliation: University of South Florida
name: Asa Oxner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Liping Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: