Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Notitia Biotechnologies Company
With
University of South Florida
Rutgers University
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
