Clinical trial: NBT-NM108 as an Early Treatment of Suspected or Confirmed COVID-19 in Patients With Prediabetes or Type 2 Diabetes (NCT04540406)

Eligibility criteria:
Inclusion Criteria:

          -  Aged between 18 to 69 (inclusive)

          -  Have prediabetes or T2DM

          -  Have mild to moderate COVID-19-like symptoms based on the symptom list from the CDC
             (updated May 13, 2020) and the severity categorization from FDA (20):

               1. 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

               2. 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 the study physician

          -  Confirm study enrollment within 4 days of symptoms onset

          -  Practice acceptable contraception, i.e., continue with current methods if participants
             are already practicing contraception, otherwise, participants must agree to practice
             contraception with a barrier method (male or female condom) or abstinence, from Day 0
             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 received a COVID-19 vaccine or plan to be vaccinated before enrollment

          -  Have tested positive for COVID-19 and recovered

          -  Receiving Remdesivir or Baricitinib for medical conditions not related to COVID-19

          -  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

          -  Chronic lung disease or moderate/severe asthma

          -  Heart failure, coronary artery disease, congenital heart disease, cardiomyopathies or
             pulmonary hypertension

          -  Chronic kidney disease on dialysis

          -  Chronic liver disease (cirrhosis)

          -  Immunocompromised, e.g. cancer treatment, bone marrow/organ transplant, immune
             deficiency, poorly controlled HIV/AIDS, prolonged use of steroids or other
             immunosuppressant medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 69 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? 0