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

NCT ID: NCT04540406

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2022-03-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NBT-NM108 + Usual Care

Group Type: EXPERIMENTAL

NBT-NM108

Intervention Type: 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.

Usual Care Only

Group Type: ACTIVE_COMPARATOR

Usual Care Only

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Usual Care Only

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

Rutgers University

OTHER

Sponsor Role: collaborator

Notitia Biotechnologies Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asa Oxner, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Liping Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

University of South Florida Morsani College of Medicine

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NBTNM10810012020

Identifier Type: -

Identifier Source: org_study_id