Title
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Phase
Phase 2Lead Sponsor
Notitia Biotechnologies CompanyStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Suspected or Confirmed COVID-19Intervention/Treatment
NBT-NM108 ...Study Participants
44This 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.
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.
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
