Trial Outcomes & Findings for NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients (NCT NCT04540406)
NCT ID: NCT04540406
Last Updated: 2024-10-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Day 0-28
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
19
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
Baseline characteristics by cohort
| Measure |
NBT-NM108 + Usual Care
n=16 Participants
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.
|
Usual Care Only
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0-28Amplicon 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.
Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
n=16 Participants
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.
|
Usual Care Only (Day 28)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
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
|
0.857 percentage
Standard Deviation 1.031
|
0.703 percentage
Standard Deviation 0.77
|
1.054 percentage
Standard Deviation 1.23
|
|
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
|
0.23 percentage
Standard Deviation 0.457
|
0.067 percentage
Standard Deviation 0.191
|
0.122 percentage
Standard Deviation 0.252
|
|
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
|
0.044 percentage
Standard Deviation 0.181
|
0.311 percentage
Standard Deviation 1.131
|
0.043 percentage
Standard Deviation 0.168
|
|
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
|
0.1 percentage
Standard Deviation 0.246
|
0.029 percentage
Standard Deviation 0.089
|
0.088 percentage
Standard Deviation 0.228
|
|
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
|
0.001 percentage
Standard Deviation 0.003
|
0.001 percentage
Standard Deviation 0.003
|
0.001 percentage
Standard Deviation 0.003
|
|
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
|
6.251 percentage
Standard Deviation 7.363
|
7.986 percentage
Standard Deviation 7.997
|
5.54 percentage
Standard Deviation 5.399
|
|
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
|
0.164 percentage
Standard Deviation 0.149
|
0.185 percentage
Standard Deviation 0.273
|
0.142 percentage
Standard Deviation 0.198
|
|
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
|
0.068 percentage
Standard Deviation 0.279
|
0.225 percentage
Standard Deviation 0.98
|
0.072 percentage
Standard Deviation 0.279
|
|
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
|
0.02 percentage
Standard Deviation 0.046
|
0.024 percentage
Standard Deviation 0.065
|
0.02 percentage
Standard Deviation 0.041
|
|
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
|
0.012 percentage
Standard Deviation 0.025
|
0.004 percentage
Standard Deviation 0.013
|
0.007 percentage
Standard Deviation 0.019
|
|
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
|
0 percentage
Standard Deviation 0
|
0.01 percentage
Standard Deviation 0.042
|
0 percentage
Standard Deviation 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
|
0.009 percentage
Standard Deviation 0.025
|
0.006 percentage
Standard Deviation 0.024
|
0 percentage
Standard Deviation 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
|
0.005 percentage
Standard Deviation 0.011
|
0.001 percentage
Standard Deviation 0.003
|
0.002 percentage
Standard Deviation 0.006
|
|
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
|
0 percentage
Standard Deviation 0
|
0.003 percentage
Standard Deviation 0.013
|
0 percentage
Standard Deviation 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
|
0 percentage
Standard Deviation 0
|
0.001 percentage
Standard Deviation 0.004
|
0 percentage
Standard Deviation 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
|
0.001 percentage
Standard Deviation 0.005
|
0.002 percentage
Standard Deviation 0.006
|
0 percentage
Standard Deviation 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
|
0.003 percentage
Standard Deviation 0.007
|
0 percentage
Standard Deviation 0.001
|
0.002 percentage
Standard Deviation 0.003
|
|
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
|
0 percentage
Standard Deviation 0
|
0.004 percentage
Standard Deviation 0.014
|
0 percentage
Standard Deviation 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
|
0.001 percentage
Standard Deviation 0.003
|
0 percentage
Standard Deviation 0.002
|
0.002 percentage
Standard Deviation 0.006
|
|
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
|
0 percentage
Standard Deviation 0
|
0 percentage
Standard Deviation 0.002
|
0 percentage
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At days 0, 14, 28, and 56Hospitalization or death
Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
Number of Participants That Were Hospitalized or Died From COVID19
Day 0
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants That Were Hospitalized or Died From COVID19
Day 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants That Were Hospitalized or Died From COVID19
Day 28
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants That Were Hospitalized or Died From COVID19
Day 56
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At days 0, 14, 28, and 56(not specified)
Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
Day 0
|
16 Participants
|
15 Participants
|
—
|
—
|
|
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
Day 14
|
16 Participants
|
15 Participants
|
—
|
—
|
|
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
Day 28
|
16 Participants
|
15 Participants
|
—
|
—
|
|
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
Day 56
|
16 Participants
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At days 0, 14, 28, and 56Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
Number of Participants Who Visited the Emergency Room From COVID-19
Day 0
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Visited the Emergency Room From COVID-19
Day 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Visited the Emergency Room From COVID-19
Day 28
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Visited the Emergency Room From COVID-19
Day 56
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At days 28 and 56All 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%.
Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
Proportion of Participants Who Have Complete Resolution of Objective Symptoms
Day 28
|
11 Participants
|
11 Participants
|
—
|
—
|
|
Proportion of Participants Who Have Complete Resolution of Objective Symptoms
Day 56
|
16 Participants
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At days 28 and 56Absence 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
Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms
Day 28
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms
Day 56
|
16 Participants
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At days 28 and 56Proportion 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
Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough
Day 28
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Proportion of Participants Who Have Complete Resolution of Subjective Symptoms Except Fatigue and Cough
Day 56
|
16 Participants
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0Proportion of participants who meet each COVID-19 category in both mild, moderate, and severe categories
Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
|---|---|---|---|---|
|
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
mild
|
8 Participants
|
7 Participants
|
—
|
—
|
|
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
moderate
|
8 Participants
|
8 Participants
|
—
|
—
|
|
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
severe
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0 Participants
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0 Participants
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—
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—
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SECONDARY outcome
Timeframe: At days 0, 14, 28, and 56Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
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Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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NBT-NM108 + Usual Care (Day 28)
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.
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Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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|---|---|---|---|---|
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Oral Body Temperature (F)
Day 0
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97.1 Degrees Fahrenheit (F)
Standard Deviation 1.2
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97.4 Degrees Fahrenheit (F)
Standard Deviation 1.3
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—
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—
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Oral Body Temperature (F)
Day 14
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97.9 Degrees Fahrenheit (F)
Standard Deviation 0.5
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97.3 Degrees Fahrenheit (F)
Standard Deviation 0.6
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—
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—
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Oral Body Temperature (F)
Day 28
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97.1 Degrees Fahrenheit (F)
Standard Deviation 0.8
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97.4 Degrees Fahrenheit (F)
Standard Deviation 0.7
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—
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—
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Oral Body Temperature (F)
Day 56
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97.6 Degrees Fahrenheit (F)
Standard Deviation 1.0
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97.1 Degrees Fahrenheit (F)
Standard Deviation 0.9
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—
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—
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SECONDARY outcome
Timeframe: At days 0, 14, 28, and 56Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
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Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
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Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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|---|---|---|---|---|
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Oxygen Saturation SpO2 Level
Day 0
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96.5 percentage of oxygen saturation
Standard Deviation 1.7
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97.3 percentage of oxygen saturation
Standard Deviation 1.3
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—
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—
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Oxygen Saturation SpO2 Level
Day 14
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98.1 percentage of oxygen saturation
Standard Deviation 1.1
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97.6 percentage of oxygen saturation
Standard Deviation 1.0
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—
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—
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Oxygen Saturation SpO2 Level
Day 28
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97.0 percentage of oxygen saturation
Standard Deviation 1.2
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98.4 percentage of oxygen saturation
Standard Deviation 1.1
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—
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—
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Oxygen Saturation SpO2 Level
Day 56
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93.0 percentage of oxygen saturation
Standard Deviation 1.1
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94.0 percentage of oxygen saturation
Standard Deviation 1.2
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—
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—
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SECONDARY outcome
Timeframe: At days 0, 14, 28, and 56Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
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Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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|---|---|---|---|---|
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Pulse Rate Per Minute
Day 0
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78.0 beats per minute
Standard Deviation 9
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79.9 beats per minute
Standard Deviation 10.1
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—
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—
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Pulse Rate Per Minute
Day 14
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79.7 beats per minute
Standard Deviation 5.9
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78.8 beats per minute
Standard Deviation 6.2
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—
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—
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Pulse Rate Per Minute
Day 28
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71.0 beats per minute
Standard Deviation 6.5
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72.1 beats per minute
Standard Deviation 9.4
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—
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—
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Pulse Rate Per Minute
Day 56
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70.5 beats per minute
Standard Deviation 6.7
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71 beats per minute
Standard Deviation 6.3
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—
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—
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SECONDARY outcome
Timeframe: At days 0, 14, 28, and 56Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
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Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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|---|---|---|---|---|
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Respiratory Rate Per Minute
Day 0
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18.1 breaths per minute
Standard Deviation 12.1
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18.3 breaths per minute
Standard Deviation 13.2
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—
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—
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Respiratory Rate Per Minute
Day 14
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17.0 breaths per minute
Standard Deviation 5.0
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17.5 breaths per minute
Standard Deviation 4.5
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—
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—
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Respiratory Rate Per Minute
Day 28
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15.4 breaths per minute
Standard Deviation 4.9
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14.1 breaths per minute
Standard Deviation 5.1
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—
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—
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Respiratory Rate Per Minute
Day 56
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13.6 breaths per minute
Standard Deviation 5.0
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14 breaths per minute
Standard Deviation 5.2
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—
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—
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SECONDARY outcome
Timeframe: At days 0 and 28Outcome measures
| Measure |
NBT-NM108 + Usual Care (Day 0)
n=16 Participants
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.
|
Usual Care Only (Day 0)
n=15 Participants
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
|
NBT-NM108 + Usual Care (Day 28)
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.
|
Usual Care Only (Day 28)
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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|---|---|---|---|---|
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Fasting Blood Glucose
Day 0
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91 mg/dL
Standard Deviation 6
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92 mg/dL
Standard Deviation 6.8
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—
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—
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Fasting Blood Glucose
Day 28
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90 mg/dL
Standard Deviation 5.2
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89 mg/dL
Standard Deviation 7
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—
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—
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Adverse Events
NBT-NM108 + Usual Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Usual Care Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NBT-NM108 + Usual Care
n=16 participants at risk
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.
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Usual Care Only
n=15 participants at risk
Usual Care Only: Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
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|---|---|---|
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General disorders
Mild adverse events
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18.8%
3/16 • Number of events 3 • 3 months
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0.00%
0/15 • 3 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place