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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
University of South Florida Morsani College of Medicine
Tampa, Florida, United States
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.
Time frame: Day 0-28
Number of Participants That Were Hospitalized or Died From COVID19
Hospitalization or death
Time frame: At days 0, 14, 28, and 56
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
(not specified)
Time frame: At days 0, 14, 28, and 56
Number of Participants Who Visited the Emergency Room From COVID-19
Time frame: At days 0, 14, 28, and 56
Proportion of Participants Who Have Complete Resolution of Objective Symptoms
All vitals signs are within normal range for at least 24h, including body temperature 36.4-37.5C (97.7-99.5F), pulse rate \<90/min, respiratory rate 12-16/min, and oxygen saturation level at 95-100%.
Time frame: At days 28 and 56
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms
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Absence of all COVID-19-like symptoms listed by CDC (updated May 13, 2020) for at least 48h, including the presence of chills or "feeling feverish" , 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
Time frame: At days 28 and 56
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough
Proportion of participants who have complete resolution of subjective symptoms except fatigue and cough, i.e. absence of all COVID-19-like symptoms listed by CDC (updated May 13, 2020) for at least 48 h, including the presence of chills or "feeling feverish", 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
Time frame: At days 28 and 56
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
Proportion of participants who meet each COVID-19 category in both mild, moderate, and severe categories
Time frame: Day 0
Oral Body Temperature (F)
Time frame: At days 0, 14, 28, and 56
Oxygen Saturation SpO2 Level
Time frame: At days 0, 14, 28, and 56
Pulse Rate Per Minute
Time frame: At days 0, 14, 28, and 56
Respiratory Rate Per Minute
Time frame: At days 0, 14, 28, and 56
Fasting Blood Glucose
Time frame: At days 0 and 28