N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)

Sponsor
Quantinosis.ai LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04706416
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
73.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: N-acetyl glucosamine (NAG)
  • Other: Control
Phase 1

Detailed Description

This is a single center, prospective, observational cohort study. A total of 150 cases who test positive for the novel coronavirus (COVID-19) will be recruited. Presenting to the emergency room of the study site, these cases will be treated with N-acetylglucosamine (NAG) in 700 mg doses every 12 hours as first-line treatment for 30 days. Standard of care (e.g., remdesivir approved for emergency use in severe cases, ventilator for patients with respiratory failure, etc.) will be provided based on the patient's clinical needs, which will be at the discretion of the treating physician. Upon admission, the research team will record patient demographics, comorbidities, symptoms, disease severity (as assessed by the World Health Organization Ordinal Scale for Clinical Improvement), need for supplemental oxygen, and time from symptom onset until hospital arrival. The research team will also collect bloodwork for the following at admission: white blood cell count (WBC), hematocrit (HCT), hemoglobin (HBG), C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6), and erythrocyte sedimentation rate (ESR). During the study period, discretionary treatments and interventions will be recorded daily until study exit. The primary outcomes of interest are rate of intubation, hospital length of stay, and mortality. Secondary outcomes of interest include intensive care unit (ICU) admission, ICU length of stay (LOS), supplemental oxygen duration, rate of hospice initiation, and poor clinical outcome (defined as combined death/hospice initiation).

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Actual Study Start Date :
Nov 14, 2020
Actual Primary Completion Date :
Jan 15, 2021
Actual Study Completion Date :
Jan 15, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: N-Acetyl Glucosamine

All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).

Dietary Supplement: 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.

Placebo Comparator: Control

All patients in the comparator arm were admitted to the same hospital with COVID-19 but did not receive N-Acetyl Glucosamine treatment. All these patients were identified retrospectively.

Other: Control
Patients do not receive treatment with N-Acetylglucosamine. They may receive other treatments at the discretion of the treating physician, as with the treatment group.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Intubated During Hospitalization [Through study completion (duration of patient's hospitalization), an average of 7-10 days.]

    The occurrence of intubation during hospitalization.

  2. Number of Participants Who Died During Hospitalization [Through study completion (duration of patient's hospitalization), an average of 7-10 days.]

    The occurrence of death during hospitalization.

  3. Hospital Length of Stay (LOS) [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.

Secondary Outcome Measures

  1. Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization [Through study completion (duration of patient's hospitalization), an average of 7-10 days.]

    The occurrence of intensive care unit (ICU) admission.

  2. ICU Length of Stay [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.

  3. Supplemental Oxygen Duration [Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.]

    The duration of supplemental oxygen use.

  4. Number of Participants Who Experienced Hospice Initiation During Hospitalization [Through study completion (duration of patient's hospitalization), an average of 7-10 days.]

    The occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.

  5. Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization [Through study completion (duration of patient's hospitalization), an average of 7-10 days.]

    The occurrence of either death or initiation of hospice proceedings.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ≥18 years old

  • Treated with N-acetyl glucosamine (NAG) as first-line treatment

  • Present with coronavirus disease 2019 (COVID-19) symptoms (including but not limited to fever, cough, shortness of breath, sore throat, nasal congestion, malaise, headache, muscle pain, loss of taste and/or smell, diarrhea, and vomiting)

  • Clinically diagnosed with COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)

  • No intubation prior to hospitalization and enrollment in the current study.

Exclusion Criteria:
  • <18 years old upon admission

  • Allergy to NAG

  • Allergy to shellfish

  • Currently taking warfarin

  • Currently pregnant or lactating

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Valley Baptist Medical CenterHarlingenTexasUnited States78550

Sponsors and Collaborators

  • Quantinosis.ai LLC

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Quantinosis.ai LLC
ClinicalTrials.gov Identifier:
NCT04706416
Other Study ID Numbers:
  • IRB #2020-106
First Posted:
Jan 12, 2021
Last Update Posted:
Nov 4, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Quantinosis.ai LLC
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailNo significant events in the study occurred after enrollment and prior to administration of the treatment.
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll 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.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).
Period Title: Overall Study
STARTED50100
COMPLETED48100
NOT COMPLETED20

Baseline Characteristics

Arm/Group TitleN-Acetyl GlucosamineControlTotal
Arm/Group DescriptionAll 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.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 of all reporting groups
Overall Participants48100148
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
63
68
67
Sex: Female, Male (Count of Participants)
Female
24
50%
38
38%
62
41.9%
Male
24
50%
62
62%
86
58.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
43
89.6%
88
88%
131
88.5%
Not Hispanic or Latino
5
10.4%
12
12%
17
11.5%
Unknown or Not Reported
0
0%
0
0%
0
0%
Time from symptom onset (days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [days]
12
7
8.5
Disease severity (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]
4
4
4
Supplemental oxygen use (Count of Participants)
Count of Participants [Participants]
46
95.8%
86
86%
132
89.2%
White blood cell (WBC) (x 10^9 cells/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [x 10^9 cells/L]
8.65
10.25
9.6
Hematocrit (hct) (percentage of red blood cells) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of red blood cells]
39.71
(6.02)
37.97
(7.93)
38.54
(7.385)
Hemoglobin (Hb) (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]
12.69
(1.91)
12.10
(2.61)
12.3
(2.47)
Asthma (Count of Participants)
Count of Participants [Participants]
0
0%
3
3%
3
2%
Atrial fibrillation (Count of Participants)
Count of Participants [Participants]
2
4.2%
7
7%
9
6.1%
Coronary artery disease (Count of Participants)
Count of Participants [Participants]
6
12.5%
17
17%
23
15.5%
Chronic heart failure (Count of Participants)
Count of Participants [Participants]
1
2.1%
7
7%
8
5.4%
Chronic obstructive pulmonary disease (COPD) (Count of Participants)
Count of Participants [Participants]
3
6.3%
11
11%
14
9.5%
End-stage renal disease (ESRD) (Count of Participants)
Count of Participants [Participants]
7
14.6%
9
9%
16
10.8%
Hyperlipidemia (Count of Participants)
Count of Participants [Participants]
13
27.1%
36
36%
49
33.1%
Hypertension (Count of Participants)
Count of Participants [Participants]
22
45.8%
71
71%
93
62.8%
Obesity (Count of Participants)
Count of Participants [Participants]
27
56.3%
40
40%
67
45.3%
Smoker (Count of Participants)
Count of Participants [Participants]
1
2.1%
1
1%
2
1.4%
Positive chest x-ray (Count of Participants)
Count of Participants [Participants]
46
95.8%
87
87%
133
89.9%
Received antibiotics (Count of Participants)
Count of Participants [Participants]
43
89.6%
94
94%
137
92.6%
Received antivirals (Count of Participants)
Count of Participants [Participants]
13
27.1%
6
6%
19
12.8%
Received corticosteroids (Count of Participants)
Count of Participants [Participants]
43
89.6%
78
78%
121
81.8%
Received convalescent plasma (Count of Participants)
Count of Participants [Participants]
2
4.2%
4
4%
6
4.1%

Outcome Measures

1. Primary Outcome
TitleNumber of Participants Intubated During Hospitalization
DescriptionThe occurrence of intubation during hospitalization.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll 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.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).
Measure Participants48100
Count of Participants [Participants]
8
16.7%
25
25%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.297
Comments
MethodFisher Exact
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.60
Confidence Interval (2-Sided) 95%
0.26 to 1.48
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.541
Comments
MethodRegression, Logistic
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.68
Confidence Interval (2-Sided) 95%
0.19 to 2.30
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
TitleNumber of Participants Who Died During Hospitalization
DescriptionThe occurrence of death during hospitalization.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll 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.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).
Measure Participants48100
Count of Participants [Participants]
6
12.5%
28
28%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.039
Comments
MethodFisher Exact
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.37
Confidence Interval (2-Sided) 95%
0.15 to 0.91
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.081
Comments
MethodRegression, Logistic
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.34
Confidence Interval (2-Sided) 95%
0.09 to 1.07
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
TitleHospital Length of Stay (LOS)
DescriptionThe number of days the patient is hospitalized.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll 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.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).
Measure Participants48100
Median (Inter-Quartile Range) [days]
7
7.5
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.643
Comments
MethodWilcoxon (Mann-Whitney)
Comments
Method of EstimationEstimation ParameterHodges-Lehmann estimator
Estimated Value0
Confidence Interval (2-Sided) 95%
-1.0 to 3.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.001
Comments
MethodRegression, Linear
Comments
Method of EstimationEstimation Parameterβ-coefficient
Estimated Value-4.27
Confidence Interval (2-Sided) 95%
-5.67 to -2.87
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
TitleNumber of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
DescriptionThe occurrence of intensive care unit (ICU) admission.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll 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.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).
Measure Participants48100
Count of Participants [Participants]
11
22.9%
36
36%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.133
Comments
MethodFisher Exact
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.53
Confidence Interval (2-Sided) 95%
0.25 to 1.19
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
TitleICU Length of Stay
DescriptionThe number of days the patient is in the ICU.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19). 10 treatment patients were admitted to the ICU and had ICU LOS data available.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). 36 control patients were admitted to the ICU and had ICU LOS data available.
Measure Participants1136
Median (Inter-Quartile Range) [days]
2.5
9.0
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.092
Comments
MethodWilcoxon (Mann-Whitney)
Comments
Method of EstimationEstimation ParameterHodges-Lehmann estimator
Estimated Value4.0
Confidence Interval (2-Sided) 95%
-1.0 to 12.0
Parameter Dispersion Type:
Value:
Estimation Comments
6. Secondary Outcome
TitleSupplemental Oxygen Duration
DescriptionThe duration of supplemental oxygen use.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.

Outcome Measure Data

Analysis Population Description
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.
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).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).
Measure Participants4686
Median (Inter-Quartile Range) [days]
7
7
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.834
Comments
MethodWilcoxon (Mann-Whitney)
Comments
Method of EstimationEstimation ParameterHodges-Lehmann estimator
Estimated Value0
Confidence Interval (2-Sided) 95%
-2.0 to 2.0
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
TitleNumber of Participants Who Experienced Hospice Initiation During Hospitalization
DescriptionThe occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description
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.
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).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).
Measure Participants4272
Count of Participants [Participants]
0
0%
4
4%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.149
Comments
MethodFisher Exact
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.001
Confidence Interval (2-Sided) 95%
0 to 1.52
Parameter Dispersion Type:
Value:
Estimation Comments
8. Secondary Outcome
TitleNumber of Participants Who Experienced Poor Clinical Outcome During Hospitalization
DescriptionThe occurrence of either death or initiation of hospice proceedings.
Time FrameThrough study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll 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.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).
Measure Participants48100
Count of Participants [Participants]
6
12.5%
32
32%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection N-Acetyl Glucosamine, Control
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value0.015
Comments
MethodFisher Exact
Comments
Method of EstimationEstimation ParameterOdds Ratio (OR)
Estimated Value0.30
Confidence Interval (2-Sided) 95%
0.12 to 0.80
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time FramePatients were followed for the duration of the study period, which began at hospital admission/study enrollment and ended upon discharge, expiration, or 30 days.
Adverse Event Reporting Description
Arm/Group TitleN-Acetyl GlucosamineControl
Arm/Group DescriptionAll 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.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).
All Cause Mortality
N-Acetyl GlucosamineControl
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/48 (12.5%) 28/100 (28%)
Serious Adverse Events
N-Acetyl GlucosamineControl
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/48 (0%) 0/100 (0%)
Other (Not Including Serious) Adverse Events
N-Acetyl GlucosamineControl
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/48 (0%) 0/100 (0%)

Limitations/Caveats

The conclusions that can be drawn from this study are limited by the relatively small number of participants, lack of randomization, use of a retrospective control arm, use of consecutive patients, temporality of different study arms in different stages of the pandemic, taking place at a single center, concomitant therapies, and potentially confounding baseline variables. These limitations were considered necessary costs in order to rapidly provide information during the COVID-19 pandemic.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDr. Ameer Hassan
OrganizationValley Baptist Medical Center
Phone973-303-8146
Emailameerehassan@gmail.com
Responsible Party:
Quantinosis.ai LLC
ClinicalTrials.gov Identifier:
NCT04706416
Other Study ID Numbers:
  • IRB #2020-106
First Posted:
Jan 12, 2021
Last Update Posted:
Nov 4, 2021
Last Verified:
Nov 1, 2021