Phase 2
Completed N=42
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Suspected or Confirmed COVID-19
Source: ClinicalTrials.gov NCT04540406 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: 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 — 7.74; 6.251; 7.986; 5.54 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
7.74; 6.251; 7.986; 5.54; 1.211; 0.857 | — |
| SECONDARY Number of Participants That Were Hospitalized or Died From COVID19 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Proportion of Participants Who Are "Alive and Not Admitted to the Hospital" |
16; 15; 16; 15; 16; 15 | — |
| SECONDARY Number of Participants Who Visited the Emergency Room From COVID-19 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Proportion of Participants Who Have Complete Resolution of Objective Symptoms |
11; 11; 16; 15 | — |
| SECONDARY Proportion of Participants Who Have Complete Resolution of Subjective Symptoms |
5; 7; 16; 15 | — |
| SECONDARY Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough |
5; 7; 16; 15 | — |
| SECONDARY Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document |
8; 7; 8; 8; 0; 0 | — |
| SECONDARY Oral Body Temperature (F) |
97.1; 97.4; 97.9; 97.3; 97.1; 97.4 | — |
| SECONDARY Oxygen Saturation SpO2 Level |
96.5; 97.3; 98.1; 97.6; 97.0; 98.4 | — |
| SECONDARY Pulse Rate Per Minute |
78.0; 79.9; 79.7; 78.8; 71.0; 72.1 | — |
| SECONDARY Respiratory Rate Per Minute |
18.1; 18.3; 17.0; 17.5; 15.4; 14.1 | — |
| SECONDARY Fasting Blood Glucose |
91; 92; 90; 89 | — |
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
Data sourced from ClinicalTrials.gov (NCT04540406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.