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

Phase 2

Completed

Conditions: Suspected or Confirmed COVID-19

Interventions: Drug: NBT-NM108
Other: Usual Care Only

Registration Number: NCT04540406

Lead Sponsor: Notitia Biotechnologies Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 42

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBT-NM108 + Usual Care	NBT-NM108	-
Usual Care Only	Usual Care Only	-

Primary Outcome Measures

Name	Time	Method
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	Day 0-28	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Were Hospitalized or Died From COVID19	At days 0, 14, 28, and 56	Hospitalization or death
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"	At days 0, 14, 28, and 56	(not specified)
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	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%.
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms	At days 28 and 56	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
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough	At days 28 and 56	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
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document	Day 0	Proportion of participants who meet each COVID-19 category in both mild, moderate, and severe categories
Oral Body Temperature (F)	At days 0, 14, 28, and 56
Oxygen Saturation SpO2 Level	At days 0, 14, 28, and 56
Pulse Rate Per Minute	At days 0, 14, 28, and 56
Respiratory Rate Per Minute	At days 0, 14, 28, and 56
Fasting Blood Glucose	At days 0 and 28