Trial Outcomes & Findings for N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19) (NCT NCT04706416)
NCT ID: NCT04706416
Last Updated: 2023-04-04
Results Overview
The occurrence of intubation during hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
150 participants
Primary outcome timeframe
Through study completion (duration of patient's hospitalization), an average of 7-10 days.
Results posted on
2023-04-04
Participant Flow
No significant events in the study occurred after enrollment and prior to administration of the treatment.
Participant milestones
| Measure |
N-Acetyl Glucosamine
All patients in the prospective arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
All patients in the retrospective arm of the study were admitted to the same hospital for coronavirus disease 2019 (COVID-19), but they were not treated with the study treatment (N-Acetyl Glucosamine).
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
100
|
|
Overall Study
COMPLETED
|
48
|
100
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
N-Acetyl Glucosamine
All patients in the prospective arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
All patients in the retrospective arm of the study were admitted to the same hospital for coronavirus disease 2019 (COVID-19), but they were not treated with the study treatment (N-Acetyl Glucosamine).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Baseline characteristics by cohort
| Measure |
N-Acetyl Glucosamine
n=48 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=100 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
68 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 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
|
|
Time from symptom onset
|
12 days
n=5 Participants
|
7 days
n=7 Participants
|
8.5 days
n=5 Participants
|
|
Disease severity
|
4 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
|
Supplemental oxygen use
|
46 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
White blood cell (WBC)
|
8.65 x 10^9 cells/L
n=5 Participants
|
10.25 x 10^9 cells/L
n=7 Participants
|
9.6 x 10^9 cells/L
n=5 Participants
|
|
Hematocrit (hct)
|
39.71 percentage of red blood cells
STANDARD_DEVIATION 6.02 • n=5 Participants
|
37.97 percentage of red blood cells
STANDARD_DEVIATION 7.93 • n=7 Participants
|
38.54 percentage of red blood cells
STANDARD_DEVIATION 7.385 • n=5 Participants
|
|
Hemoglobin (Hb)
|
12.69 g/dL
STANDARD_DEVIATION 1.91 • n=5 Participants
|
12.10 g/dL
STANDARD_DEVIATION 2.61 • n=7 Participants
|
12.3 g/dL
STANDARD_DEVIATION 2.47 • n=5 Participants
|
|
Asthma
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Atrial fibrillation
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Coronary artery disease
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Chronic heart failure
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Chronic obstructive pulmonary disease (COPD)
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
End-stage renal disease (ESRD)
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Hyperlipidemia
|
13 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Hypertension
|
22 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Obesity
|
27 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Smoker
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Positive chest x-ray
|
46 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Received antibiotics
|
43 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Received antivirals
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Received corticosteroids
|
43 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Received convalescent plasma
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days.The occurrence of intubation during hospitalization.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=48 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=100 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
Number of Participants Intubated During Hospitalization
|
8 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days.The occurrence of death during hospitalization.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=48 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=100 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
Number of Participants Who Died During Hospitalization
|
6 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.The number of days the patient is hospitalized.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=48 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=100 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
Hospital Length of Stay (LOS)
|
7 days
Interval 5.0 to 11.75
|
7.5 days
Interval 4.0 to 17.0
|
SECONDARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days.The occurrence of intensive care unit (ICU) admission.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=48 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=100 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
|
11 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.The number of days the patient is in the ICU.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=11 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=36 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
ICU Length of Stay
|
2.5 days
Interval 0.75 to 14.75
|
9.0 days
Interval 2.25 to 21.5
|
SECONDARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.Population: 46 treatment patients received supplemental oxygen support and had length of use data available. 86 control patients received supplemental oxygen support and had length of use data available.
The duration of supplemental oxygen use.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=46 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=86 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
Supplemental Oxygen Duration
|
7 days
Interval 5.0 to 12.0
|
7 days
Interval 3.0 to 15.0
|
SECONDARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days.Population: The hospice initiation cohort excludes those patients who died. 42 treatment patients survived and had hospice initiation data available. 72 control patients survived and had hospice initiation data available.
The occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=42 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=72 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
Number of Participants Who Experienced Hospice Initiation During Hospitalization
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Through study completion (duration of patient's hospitalization), an average of 7-10 days.The occurrence of either death or initiation of hospice proceedings.
Outcome measures
| Measure |
N-Acetyl Glucosamine
n=48 Participants
All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
N-acetyl glucosamine (NAG): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
|
Control
n=100 Participants
All patients in the comparative arm of the study were sampled retrospectively. All were admitted to the same hospital for coronavirus disease 2019 (COVID-19).
|
|---|---|---|
|
Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization
|
6 Participants
|
32 Participants
|
Adverse Events
N-Acetyl Glucosamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 28 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place