Suspected or Confirmed COVID-19
Conditions
Keywords
COVID-19, NBT-NM108, Notitia Biotechnologies Company, Notitia Biotechnologies, Microbiome, Microbiota, Gut microbiome, Gut microbiota, Corona Virus, Novel Corona Virus, SARS-CoV-2
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.
Interventions
DRUGNBT-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.
OTHERUsual Care Only
Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
Sponsors
University of South Florida
Rutgers University
Notitia Biotechnologies Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of Participants That Were Hospitalized or Died From COVID19 | At days 0, 14, 28, and 56 | Hospitalization or death |
| 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 | — |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NBT-NM108 + Usual Care 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. | 16 |
| Usual Care Only Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108. | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | NBT-NM108 + Usual Care | Usual Care Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Continuous | 44.0 years STANDARD_DEVIATION 11.4 | 45.7 years STANDARD_DEVIATION 10.1 | 44.7 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 11 Participants | 23 Participants |
| Region of Enrollment United States | 16 participants | 15 participants | 31 participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 3 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
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
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.
Time frame: Day 0-28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnospiraceae ASV0074 (negatively correlated with PC1) | 0.003 percentage | Standard Deviation 0.009 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnospiraceae ASV05T7 (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.004 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Fusicatenibacter ASV07L5 (negatively correlated with PC1) | 0.092 percentage | Standard Deviation 0.201 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Acetanaerobacterium ASV00E7 (negatively correlated with PC1) | 0.002 percentage | Standard Deviation 0.004 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Ruminococcus_gauvreauii_group ASV0GHA (negatively correlated with PC1) | 0.002 percentage | Standard Deviation 0.012 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Agathobacter ASV00LE (positively correlated with PC1) | 7.74 percentage | Standard Deviation 8.227 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnospiraceae_NK4A136_group ASV0GHH (negatively correlated with PC1) | 0.004 percentage | Standard Deviation 0.022 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Roseburia ASV01JE (negatively correlated with PC1) | 1.211 percentage | Standard Deviation 2.551 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnospiraceae_GCA_900066575 ASV03BI (negatively correlated with PC1) | 0 percentage | Standard Deviation 0.001 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Bacteroides_uniformis ASV04EI (negatively correlated with PC1) | 0.096 percentage | Standard Deviation 0.364 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Phascolarctobacterium ASV0EJD (negatively correlated with PC1) | 0.154 percentage | Standard Deviation 0.597 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnospiraceae_UGG-010 ASV06Y8 (negatively correlated with PC1) | 0.002 percentage | Standard Deviation 0.005 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Veillonella ASV0065 (negatively correlated with PC1) | 0.022 percentage | Standard Deviation 0.048 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Frisingicoccus ASV0EAB (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.005 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnospiraceae ASV030X (negatively correlated with PC1) | 0.019 percentage | Standard Deviation 0.035 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnoclostridium ASV0034 (negatively correlated with PC1) | 0.13 percentage | Standard Deviation 0.153 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Eggerthellaceae ASV0G1P (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.002 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Shuttleworthia ASV03B1 (negatively correlated with PC1) | 0.014 percentage | Standard Deviation 0.059 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Parabacteroides ASV000W (negatively correlated with PC1) | 0.003 percentage | Standard Deviation 0.013 |
| NBT-NM108 + Usual Care (Day 0) | 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 | Lachnoclostridium ASV0055 (negatively correlated with PC1) | 0.005 percentage | Standard Deviation 0.023 |
| Usual Care Only (Day 0) | 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 | Lachnospiraceae ASV0074 (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.005 |
| Usual Care Only (Day 0) | 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 | Lachnoclostridium ASV0055 (negatively correlated with PC1) | 0.009 percentage | Standard Deviation 0.025 |
| Usual Care Only (Day 0) | 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 | Lachnospiraceae_GCA_900066575 ASV03BI (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.003 |
| Usual Care Only (Day 0) | 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 | Acetanaerobacterium ASV00E7 (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.003 |
| Usual Care Only (Day 0) | 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 | Phascolarctobacterium ASV0EJD (negatively correlated with PC1) | 0.068 percentage | Standard Deviation 0.279 |
| Usual Care Only (Day 0) | 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 | Lachnospiraceae ASV05T7 (negatively correlated with PC1) | 0.005 percentage | Standard Deviation 0.011 |
| Usual Care Only (Day 0) | 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 | Agathobacter ASV00LE (positively correlated with PC1) | 6.251 percentage | Standard Deviation 7.363 |
| Usual Care Only (Day 0) | 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 | Frisingicoccus ASV0EAB (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 0) | 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 | Parabacteroides ASV000W (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 0) | 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 | Ruminococcus_gauvreauii_group ASV0GHA (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 0) | 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 | Veillonella ASV0065 (negatively correlated with PC1) | 0.1 percentage | Standard Deviation 0.246 |
| Usual Care Only (Day 0) | 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 | Lachnospiraceae_NK4A136_group ASV0GHH (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 0) | 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 | Shuttleworthia ASV03B1 (negatively correlated with PC1) | 0.012 percentage | Standard Deviation 0.025 |
| Usual Care Only (Day 0) | 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 | Fusicatenibacter ASV07L5 (negatively correlated with PC1) | 0.23 percentage | Standard Deviation 0.457 |
| Usual Care Only (Day 0) | 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 | Eggerthellaceae ASV0G1P (negatively correlated with PC1) | 0.003 percentage | Standard Deviation 0.007 |
| Usual Care Only (Day 0) | 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 | Lachnoclostridium ASV0034 (negatively correlated with PC1) | 0.164 percentage | Standard Deviation 0.149 |
| Usual Care Only (Day 0) | 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 | Lachnospiraceae ASV030X (negatively correlated with PC1) | 0.02 percentage | Standard Deviation 0.046 |
| Usual Care Only (Day 0) | 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 | Bacteroides_uniformis ASV04EI (negatively correlated with PC1) | 0.044 percentage | Standard Deviation 0.181 |
| Usual Care Only (Day 0) | 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 | Roseburia ASV01JE (negatively correlated with PC1) | 0.857 percentage | Standard Deviation 1.031 |
| Usual Care Only (Day 0) | 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 | Lachnospiraceae_UGG-010 ASV06Y8 (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Ruminococcus_gauvreauii_group ASV0GHA (negatively correlated with PC1) | 0.003 percentage | Standard Deviation 0.013 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Agathobacter ASV00LE (positively correlated with PC1) | 7.986 percentage | Standard Deviation 7.997 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Roseburia ASV01JE (negatively correlated with PC1) | 0.703 percentage | Standard Deviation 0.77 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnoclostridium ASV0034 (negatively correlated with PC1) | 0.185 percentage | Standard Deviation 0.273 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Fusicatenibacter ASV07L5 (negatively correlated with PC1) | 0.067 percentage | Standard Deviation 0.191 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Bacteroides_uniformis ASV04EI (negatively correlated with PC1) | 0.311 percentage | Standard Deviation 1.131 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Phascolarctobacterium ASV0EJD (negatively correlated with PC1) | 0.225 percentage | Standard Deviation 0.98 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Veillonella ASV0065 (negatively correlated with PC1) | 0.029 percentage | Standard Deviation 0.089 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnospiraceae ASV030X (negatively correlated with PC1) | 0.024 percentage | Standard Deviation 0.065 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Shuttleworthia ASV03B1 (negatively correlated with PC1) | 0.004 percentage | Standard Deviation 0.013 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Parabacteroides ASV000W (negatively correlated with PC1) | 0.01 percentage | Standard Deviation 0.042 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnoclostridium ASV0055 (negatively correlated with PC1) | 0.006 percentage | Standard Deviation 0.024 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnospiraceae ASV05T7 (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.003 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnospiraceae_NK4A136_group ASV0GHH (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.004 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Acetanaerobacterium ASV00E7 (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.003 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnospiraceae ASV0074 (negatively correlated with PC1) | 0.002 percentage | Standard Deviation 0.006 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Eggerthellaceae ASV0G1P (negatively correlated with PC1) | 0 percentage | Standard Deviation 0.001 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnospiraceae_UGG-010 ASV06Y8 (negatively correlated with PC1) | 0.004 percentage | Standard Deviation 0.014 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Lachnospiraceae_GCA_900066575 ASV03BI (negatively correlated with PC1) | 0 percentage | Standard Deviation 0.002 |
| NBT-NM108 + Usual Care (Day 28) | 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 | Frisingicoccus ASV0EAB (negatively correlated with PC1) | 0 percentage | Standard Deviation 0.002 |
| Usual Care Only (Day 28) | 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 | Parabacteroides ASV000W (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 28) | 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 | Shuttleworthia ASV03B1 (negatively correlated with PC1) | 0.007 percentage | Standard Deviation 0.019 |
| Usual Care Only (Day 28) | 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 | Lachnospiraceae_GCA_900066575 ASV03BI (negatively correlated with PC1) | 0.002 percentage | Standard Deviation 0.006 |
| Usual Care Only (Day 28) | 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 | Lachnospiraceae ASV0074 (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 28) | 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 | Lachnospiraceae ASV030X (negatively correlated with PC1) | 0.02 percentage | Standard Deviation 0.041 |
| Usual Care Only (Day 28) | 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 | Veillonella ASV0065 (negatively correlated with PC1) | 0.088 percentage | Standard Deviation 0.228 |
| Usual Care Only (Day 28) | 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 | Roseburia ASV01JE (negatively correlated with PC1) | 1.054 percentage | Standard Deviation 1.23 |
| Usual Care Only (Day 28) | 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 | Eggerthellaceae ASV0G1P (negatively correlated with PC1) | 0.002 percentage | Standard Deviation 0.003 |
| Usual Care Only (Day 28) | 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 | Phascolarctobacterium ASV0EJD (negatively correlated with PC1) | 0.072 percentage | Standard Deviation 0.279 |
| Usual Care Only (Day 28) | 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 | Bacteroides_uniformis ASV04EI (negatively correlated with PC1) | 0.043 percentage | Standard Deviation 0.168 |
| Usual Care Only (Day 28) | 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 | Agathobacter ASV00LE (positively correlated with PC1) | 5.54 percentage | Standard Deviation 5.399 |
| Usual Care Only (Day 28) | 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 | Lachnospiraceae_UGG-010 ASV06Y8 (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 28) | 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 | Fusicatenibacter ASV07L5 (negatively correlated with PC1) | 0.122 percentage | Standard Deviation 0.252 |
| Usual Care Only (Day 28) | 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 | Ruminococcus_gauvreauii_group ASV0GHA (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 28) | 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 | Lachnoclostridium ASV0034 (negatively correlated with PC1) | 0.142 percentage | Standard Deviation 0.198 |
| Usual Care Only (Day 28) | 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 | Lachnospiraceae_NK4A136_group ASV0GHH (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 28) | 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 | Lachnospiraceae ASV05T7 (negatively correlated with PC1) | 0.002 percentage | Standard Deviation 0.006 |
| Usual Care Only (Day 28) | 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 | Lachnoclostridium ASV0055 (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 28) | 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 | Frisingicoccus ASV0EAB (negatively correlated with PC1) | 0 percentage | Standard Deviation 0 |
| Usual Care Only (Day 28) | 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 | Acetanaerobacterium ASV00E7 (negatively correlated with PC1) | 0.001 percentage | Standard Deviation 0.003 |
Comparison: PCoA (Principal Coordinates Analysis) + PERMANOVA (Permutational Multivariate Analysis of Variance) are exploratory multivariate techniques commonly used in microbiome research to assess and visualize differences in community composition. The null hypothesis for PERMANOVA is that there are no differences in the centroids (multivariate means) of the groups being compared. The microbial communities in different groups or conditions are not significantly different from each other.
Secondary
Fasting Blood Glucose
Time frame: At days 0 and 28
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Fasting Blood Glucose | Day 0 | 91 mg/dL | Standard Deviation 6 |
| NBT-NM108 + Usual Care (Day 0) | Fasting Blood Glucose | Day 28 | 90 mg/dL | Standard Deviation 5.2 |
| Usual Care Only (Day 0) | Fasting Blood Glucose | Day 0 | 92 mg/dL | Standard Deviation 6.8 |
| Usual Care Only (Day 0) | Fasting Blood Glucose | Day 28 | 89 mg/dL | Standard Deviation 7 |
Secondary
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
Proportion of participants who meet each COVID-19 category in both mild, moderate, and severe categories
Time frame: Day 0
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document | mild | 8 Participants |
| NBT-NM108 + Usual Care (Day 0) | Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document | moderate | 8 Participants |
| NBT-NM108 + Usual Care (Day 0) | Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document | severe | 0 Participants |
| Usual Care Only (Day 0) | Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document | mild | 7 Participants |
| Usual Care Only (Day 0) | Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document | moderate | 8 Participants |
| Usual Care Only (Day 0) | Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document | severe | 0 Participants |
Secondary
Number of Participants That Were Hospitalized or Died From COVID19
Hospitalization or death
Time frame: At days 0, 14, 28, and 56
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 0 | 0 Participants |
| NBT-NM108 + Usual Care (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 14 | 0 Participants |
| NBT-NM108 + Usual Care (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 28 | 0 Participants |
| NBT-NM108 + Usual Care (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 56 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 56 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 0 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 28 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants That Were Hospitalized or Died From COVID19 | Day 14 | 0 Participants |
Secondary
Number of Participants Who Visited the Emergency Room From COVID-19
Time frame: At days 0, 14, 28, and 56
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 28 | 0 Participants |
| NBT-NM108 + Usual Care (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 0 | 0 Participants |
| NBT-NM108 + Usual Care (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 56 | 0 Participants |
| NBT-NM108 + Usual Care (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 14 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 56 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 0 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 28 | 0 Participants |
| Usual Care Only (Day 0) | Number of Participants Who Visited the Emergency Room From COVID-19 | Day 14 | 0 Participants |
Secondary
Oral Body Temperature (F)
Time frame: At days 0, 14, 28, and 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Oral Body Temperature (F) | Day 0 | 97.1 Degrees Fahrenheit (F) | Standard Deviation 1.2 |
| NBT-NM108 + Usual Care (Day 0) | Oral Body Temperature (F) | Day 14 | 97.9 Degrees Fahrenheit (F) | Standard Deviation 0.5 |
| NBT-NM108 + Usual Care (Day 0) | Oral Body Temperature (F) | Day 28 | 97.1 Degrees Fahrenheit (F) | Standard Deviation 0.8 |
| NBT-NM108 + Usual Care (Day 0) | Oral Body Temperature (F) | Day 56 | 97.6 Degrees Fahrenheit (F) | Standard Deviation 1 |
| Usual Care Only (Day 0) | Oral Body Temperature (F) | Day 56 | 97.1 Degrees Fahrenheit (F) | Standard Deviation 0.9 |
| Usual Care Only (Day 0) | Oral Body Temperature (F) | Day 0 | 97.4 Degrees Fahrenheit (F) | Standard Deviation 1.3 |
| Usual Care Only (Day 0) | Oral Body Temperature (F) | Day 28 | 97.4 Degrees Fahrenheit (F) | Standard Deviation 0.7 |
| Usual Care Only (Day 0) | Oral Body Temperature (F) | Day 14 | 97.3 Degrees Fahrenheit (F) | Standard Deviation 0.6 |
Secondary
Oxygen Saturation SpO2 Level
Time frame: At days 0, 14, 28, and 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Oxygen Saturation SpO2 Level | Day 0 | 96.5 percentage of oxygen saturation | Standard Deviation 1.7 |
| NBT-NM108 + Usual Care (Day 0) | Oxygen Saturation SpO2 Level | Day 14 | 98.1 percentage of oxygen saturation | Standard Deviation 1.1 |
| NBT-NM108 + Usual Care (Day 0) | Oxygen Saturation SpO2 Level | Day 28 | 97.0 percentage of oxygen saturation | Standard Deviation 1.2 |
| NBT-NM108 + Usual Care (Day 0) | Oxygen Saturation SpO2 Level | Day 56 | 93.0 percentage of oxygen saturation | Standard Deviation 1.1 |
| Usual Care Only (Day 0) | Oxygen Saturation SpO2 Level | Day 56 | 94.0 percentage of oxygen saturation | Standard Deviation 1.2 |
| Usual Care Only (Day 0) | Oxygen Saturation SpO2 Level | Day 0 | 97.3 percentage of oxygen saturation | Standard Deviation 1.3 |
| Usual Care Only (Day 0) | Oxygen Saturation SpO2 Level | Day 28 | 98.4 percentage of oxygen saturation | Standard Deviation 1.1 |
| Usual Care Only (Day 0) | Oxygen Saturation SpO2 Level | Day 14 | 97.6 percentage of oxygen saturation | Standard Deviation 1 |
Secondary
Proportion of Participants Who Are Alive and Not Admitted to the Hospital
(not specified)
Time frame: At days 0, 14, 28, and 56
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 0 | 16 Participants |
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 14 | 16 Participants |
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 28 | 16 Participants |
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 56 | 16 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 56 | 15 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 0 | 15 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 28 | 15 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Are Alive and Not Admitted to the Hospital | Day 14 | 15 Participants |
Secondary
Proportion of Participants Who Have Complete Resolution of Objective Symptoms
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%.
Time frame: At days 28 and 56
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Have Complete Resolution of Objective Symptoms | Day 28 | 11 Participants |
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Have Complete Resolution of Objective Symptoms | Day 56 | 16 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Have Complete Resolution of Objective Symptoms | Day 28 | 11 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Have Complete Resolution of Objective Symptoms | Day 56 | 15 Participants |
Secondary
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms
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
Time frame: At days 28 and 56
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms | Day 28 | 5 Participants |
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms | Day 56 | 16 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms | Day 28 | 7 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms | Day 56 | 15 Participants |
Secondary
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough
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
Time frame: At days 28 and 56
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough | Day 28 | 5 Participants |
| NBT-NM108 + Usual Care (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough | Day 56 | 16 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough | Day 28 | 7 Participants |
| Usual Care Only (Day 0) | Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough | Day 56 | 15 Participants |
Secondary
Pulse Rate Per Minute
Time frame: At days 0, 14, 28, and 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Pulse Rate Per Minute | Day 0 | 78.0 beats per minute | Standard Deviation 9 |
| NBT-NM108 + Usual Care (Day 0) | Pulse Rate Per Minute | Day 28 | 71.0 beats per minute | Standard Deviation 6.5 |
| NBT-NM108 + Usual Care (Day 0) | Pulse Rate Per Minute | Day 14 | 79.7 beats per minute | Standard Deviation 5.9 |
| NBT-NM108 + Usual Care (Day 0) | Pulse Rate Per Minute | Day 56 | 70.5 beats per minute | Standard Deviation 6.7 |
| Usual Care Only (Day 0) | Pulse Rate Per Minute | Day 14 | 78.8 beats per minute | Standard Deviation 6.2 |
| Usual Care Only (Day 0) | Pulse Rate Per Minute | Day 0 | 79.9 beats per minute | Standard Deviation 10.1 |
| Usual Care Only (Day 0) | Pulse Rate Per Minute | Day 56 | 71 beats per minute | Standard Deviation 6.3 |
| Usual Care Only (Day 0) | Pulse Rate Per Minute | Day 28 | 72.1 beats per minute | Standard Deviation 9.4 |
Secondary
Respiratory Rate Per Minute
Time frame: At days 0, 14, 28, and 56
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NBT-NM108 + Usual Care (Day 0) | Respiratory Rate Per Minute | Day 0 | 18.1 breaths per minute | Standard Deviation 12.1 |
| NBT-NM108 + Usual Care (Day 0) | Respiratory Rate Per Minute | Day 56 | 13.6 breaths per minute | Standard Deviation 5 |
| NBT-NM108 + Usual Care (Day 0) | Respiratory Rate Per Minute | Day 14 | 17.0 breaths per minute | Standard Deviation 5 |
| NBT-NM108 + Usual Care (Day 0) | Respiratory Rate Per Minute | Day 28 | 15.4 breaths per minute | Standard Deviation 4.9 |
| Usual Care Only (Day 0) | Respiratory Rate Per Minute | Day 28 | 14.1 breaths per minute | Standard Deviation 5.1 |
| Usual Care Only (Day 0) | Respiratory Rate Per Minute | Day 0 | 18.3 breaths per minute | Standard Deviation 13.2 |
| Usual Care Only (Day 0) | Respiratory Rate Per Minute | Day 14 | 17.5 breaths per minute | Standard Deviation 4.5 |
| Usual Care Only (Day 0) | Respiratory Rate Per Minute | Day 56 | 14 breaths per minute | Standard Deviation 5.2 |