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)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site Per Month: 73.6

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 Disease	Intervention/Treatment	Phase
Coronavirus; Covid19	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Valley Baptist Medical Center	Harlingen	Texas	United States	78550

Sponsors and Collaborators

• Quantinosis.ai LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 26, 2020

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: N-acetyl glucosamine
• Additional relevant MeSH terms: COVID-19; Coronavirus Infections

Study Results

Participant Flow

Pre-assignment Detail	No significant events in the study occurred after enrollment and prior to administration of the treatment.

Arm/Group Title	N-Acetyl Glucosamine	Control
Arm/Group Description	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.	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
STARTED	50	100
COMPLETED	48	100
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	N-Acetyl Glucosamine	Control	Total
Arm/Group Description	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.	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 Participants	48	100	148
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

Title	Number of Participants Intubated During Hospitalization
Description	The occurrence of intubation during hospitalization.
Time Frame	Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-Acetyl Glucosamine	Control
Arm/Group Description	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.	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 Participants	48	100
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 Hypothesis	p-Value	0.297
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.60
	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 Hypothesis	p-Value	0.541
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.19 to 2.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Participants Who Died During Hospitalization
Description	The occurrence of death during hospitalization.
Time Frame	Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-Acetyl Glucosamine	Control
Arm/Group Description	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.	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 Participants	48	100
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 Hypothesis	p-Value	0.039
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.37
	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 Hypothesis	p-Value	0.081
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.09 to 1.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Hospital Length of Stay (LOS)
Description	The number of days the patient is hospitalized.
Time Frame	Through 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 Title	N-Acetyl Glucosamine	Control
Arm/Group Description	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.	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 Participants	48	100
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 Hypothesis	p-Value	0.643
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	0
	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 Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	β-coefficient
	Estimated Value	-4.27
	Confidence Interval	(2-Sided) 95%; -5.67 to -2.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
Description	The occurrence of intensive care unit (ICU) admission.
Time Frame	Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-Acetyl Glucosamine	Control
Arm/Group Description	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.	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 Participants	48	100
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 Hypothesis	p-Value	0.133
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; 0.25 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	ICU Length of Stay
Description	The number of days the patient is in the ICU.
Time Frame	Through 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 Title	N-Acetyl Glucosamine	Control
Arm/Group Description	All 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 Participants	11	36
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 Hypothesis	p-Value	0.092
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	4.0
	Confidence Interval	(2-Sided) 95%; -1.0 to 12.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Supplemental Oxygen Duration
Description	The duration of supplemental oxygen use.
Time Frame	Through 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 Title	N-Acetyl Glucosamine	Control
Arm/Group Description	All 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 Participants	46	86
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 Hypothesis	p-Value	0.834
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Hodges-Lehmann estimator
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -2.0 to 2.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Number of Participants Who Experienced Hospice Initiation During Hospitalization
Description	The occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.
Time Frame	Through 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 Title	N-Acetyl Glucosamine	Control
Arm/Group Description	All 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 Participants	42	72
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 Hypothesis	p-Value	0.149
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.001
	Confidence Interval	(2-Sided) 95%; 0 to 1.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization
Description	The occurrence of either death or initiation of hospice proceedings.
Time Frame	Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	N-Acetyl Glucosamine	Control
Arm/Group Description	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.	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 Participants	48	100
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 Hypothesis	p-Value	0.015
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; 0.12 to 0.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Patients were followed for the duration of the study period, which began at hospital admission/study enrollment and ended upon discharge, expiration, or 30 days.
Arm/Group Title	N-Acetyl Glucosamine		Control
Arm/Group Description	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.		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 Glucosamine		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/48 (12.5%)		28/100 (28%)
Serious Adverse Events
	N-Acetyl Glucosamine		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	N-Acetyl Glucosamine		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (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.