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.
Drug: 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.
Other: Usual Care Only
Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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
University of South Florida Morsani College of Medicine
Tampa, Florida, United States