CoronavirusPhase 1NCT04706416

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

A Phase 1 study testing N-acetyl glucosamine (NAG) in people with Coronavirus and Covid19, run by Quantinosis.ai LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Coronavirus, Covid19
What is being tested?: N-acetyl glucosamine (NAG)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteUnited States
Study dates: 14 Nov 2020to 15 Jan 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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.

Who cannot join

<18 years old upon admission
Allergy to NAG
Allergy to shellfish
Currently taking warfarin
Currently pregnant or lactating

Trial locations and contacts

1 site in 1 country.

United States1 site

Valley Baptist Medical Center
Harlingen, Texas, 78550

Other trials in United States

About this study

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

Read the 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).

Conditions: Coronavirus, Covid19
Being tested: N-acetyl glucosamine (NAG), Control
Keywords: N-acetyl glucosamine
Medical subject headings: Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-acetyl glucosamine (NAG)Dietary supplement
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.
ControlOther
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.

Study groups in NCT04706416
Study group	Role	What they receive
N-Acetyl Glucosamine	Experimental	All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19). Receives: Dietary Supplement: N-acetyl glucosamine (NAG)
Control	Placebo comparator	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. Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Intubated During Hospitalization
The occurrence of intubation during hospitalization.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
Number of Participants Who Died During Hospitalization
The occurrence of death during hospitalization.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
Hospital Length of Stay (LOS)
The number of days the patient is hospitalized.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.

Secondary outcomes (5)

Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
The occurrence of intensive care unit (ICU) admission.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
ICU Length of Stay
The number of days the patient is in the ICU.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
Supplemental Oxygen Duration
The duration of supplemental oxygen use.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
Number of Participants Who Experienced Hospice Initiation During Hospitalization
The occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization
The occurrence of either death or initiation of hospice proceedings.
Measured: Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 202015 Jan 2021

First posted12 Jan 2021
Study start14 Nov 2020
Primary completion15 Jan 2021
Study completion15 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CoronavirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04706416
Sponsor's protocol ID: IRB #2020-106
Status last verified: Apr 2023
First submitted: 31 Dec 2020
Last updated: 4 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We will publish based on summary data, but make individual participant data available upon request. There are no plans to publish individual participant data.

Publications

Hassan AE. An observational cohort study to assess N-acetylglucosamine for COVID-19 treatment in the inpatient setting. Ann Med Surg (Lond). 2021 Aug;68:102574. doi: 10.1016/j.amsu.2021.102574. Epub 2021 Jul 16.
PubMed 34306677

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
ClinicalTrials.gov ID: NCT04706416
Acronym / sponsor ID: IRB #2020-106
Conditions: Coronavirus, Covid19
Keywords: N-acetyl glucosamine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Quantinosis.ai LLCIndustry (pharma, biotech, devices)
Study start: 14 Nov 2020 (actual)
Primary completion: 15 Jan 2021 (actual)
Study completion: 15 Jan 2021 (actual)
First posted: 12 Jan 2021 (actual)
Results: Posted 4 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
N-Acetyl Glucosamine	Experimental	Dietary Supplement: N-acetyl glucosamine (NAG)All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).
Control	Placebo comparator	Other: ControlAll 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥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.

Key exclusion criteria (5 listed)

<18 years old upon admission
Allergy to NAG
Allergy to shellfish
Currently taking warfarin
Currently pregnant or lactating

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Dietary supplement	N-Acetyl Glucosamine
ControlPatients do not receive treatment with N-Acetylglucosamine. They may receive other treatments at the discretion of the treating physician, as with the treatment group.	Other	Control

Primary outcome

Number of Participants Intubated During Hospitalization
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
The occurrence of intubation during hospitalization.
Number of Participants Who Died During Hospitalization
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
The occurrence of death during hospitalization.
Hospital Length of Stay (LOS)
Time frame: 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.

5 secondary outcomes

Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
ICU Length of Stay
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
Supplemental Oxygen Duration
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
Number of Participants Who Experienced Hospice Initiation During Hospitalization
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Results and safety

Results posted to the registry on 4 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
N-Acetyl Glucosamine	50	48
Control	100	100

Primary outcome: Number of Participants Intubated During Hospitalization

Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.. Count of participants. Unit: Participants

Measure	N-Acetyl Glucosamine n = 48	Control n = 100
Value	8	25

N-Acetyl Glucosamine vs Control: Odds Ratio (OR): 0.60 (95% CI 0.26 to 1.48), p = 0.297, Fisher Exact
N-Acetyl Glucosamine vs Control: Odds Ratio (OR): 0.68 (95% CI 0.19 to 2.30), p = 0.541, Regression, Logistic

Primary outcome: Number of Participants Who Died During Hospitalization

Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.. Count of participants. Unit: Participants

Measure	N-Acetyl Glucosamine n = 48	Control n = 100
Value	6	28

N-Acetyl Glucosamine vs Control: Odds Ratio (OR): 0.37 (95% CI 0.15 to 0.91), p = 0.039, Fisher Exact
N-Acetyl Glucosamine vs Control: Odds Ratio (OR): 0.34 (95% CI 0.09 to 1.07), p = 0.081, Regression, Logistic

Primary outcome: Hospital Length of Stay (LOS)

Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.. Median (Inter-Quartile Range). Unit: days

Measure	N-Acetyl Glucosamine n = 48	Control n = 100
Value	7 (5 to 11.75)	7.5 (4 to 17)

N-Acetyl Glucosamine vs Control: Hodges-Lehmann estimator: 0 (95% CI -1.0 to 3.0), p = 0.643, Wilcoxon (Mann-Whitney)
N-Acetyl Glucosamine vs Control: β-coefficient: -4.27 (95% CI -5.67 to -2.87), p = 0.001, Regression, Linear

5 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N-Acetyl Glucosamine	0 of 48 (0%)	0 of 48 (0%)	6 of 48
Control	0 of 100 (0%)	0 of 100 (0%)	28 of 100

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34306677Hassan AE. An observational cohort study to assess N-acetylglucosamine for COVID-19 treatment in the inpatient setting. Ann Med Surg (Lond). 2021 Aug;68:102574. doi: 10.1016/j.amsu.2021.102574. Epub 2021 Jul 16.
Individual participant dataSharing planned: No. We will publish based on summary data, but make individual participant data available upon request. There are no plans to publish individual participant data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing N-acetyl glucosamine (NAG) in people with Coronavirus and Covid19, run by Quantinosis.ai LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Intubated During Hospitalization (time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04706416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.