Coronavirus, Covid19
Conditions
Keywords
N-acetyl glucosamine
Brief summary
This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.
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).
Interventions
DIETARY_SUPPLEMENTN-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.
OTHERControl
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.
Sponsors
Quantinosis.ai LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
No significant events in the study occurred after enrollment and prior to administration of the treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 48 |
| Control 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). | 100 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | N-Acetyl Glucosamine | Control | Total |
|---|---|---|---|
| Age, Continuous | 63 years | 68 years | 67 years |
| Asthma | 0 Participants | 3 Participants | 3 Participants |
| Atrial fibrillation | 2 Participants | 7 Participants | 9 Participants |
| Chronic heart failure | 1 Participants | 7 Participants | 8 Participants |
| Chronic obstructive pulmonary disease (COPD) | 3 Participants | 11 Participants | 14 Participants |
| Coronary artery disease | 6 Participants | 17 Participants | 23 Participants |
| Disease severity | 4 units on a scale | 4 units on a scale | 4 units on a scale |
| End-stage renal disease (ESRD) | 7 Participants | 9 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 88 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 12 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hematocrit (hct) | 39.71 percentage of red blood cells STANDARD_DEVIATION 6.02 | 37.97 percentage of red blood cells STANDARD_DEVIATION 7.93 | 38.54 percentage of red blood cells STANDARD_DEVIATION 7.385 |
| Hemoglobin (Hb) | 12.69 g/dL STANDARD_DEVIATION 1.91 | 12.10 g/dL STANDARD_DEVIATION 2.61 | 12.3 g/dL STANDARD_DEVIATION 2.47 |
| Hyperlipidemia | 13 Participants | 36 Participants | 49 Participants |
| Hypertension | 22 Participants | 71 Participants | 93 Participants |
| Obesity | 27 Participants | 40 Participants | 67 Participants |
| Positive chest x-ray | 46 Participants | 87 Participants | 133 Participants |
| Received antibiotics | 43 Participants | 94 Participants | 137 Participants |
| Received antivirals | 13 Participants | 6 Participants | 19 Participants |
| Received convalescent plasma | 2 Participants | 4 Participants | 6 Participants |
| Received corticosteroids | 43 Participants | 78 Participants | 121 Participants |
| Sex: Female, Male Female | 24 Participants | 38 Participants | 62 Participants |
| Sex: Female, Male Male | 24 Participants | 62 Participants | 86 Participants |
| Smoker | 1 Participants | 1 Participants | 2 Participants |
| Supplemental oxygen use | 46 Participants | 86 Participants | 132 Participants |
| Time from symptom onset | 12 days | 7 days | 8.5 days |
| White blood cell (WBC) | 8.65 x 10^9 cells/L | 10.25 x 10^9 cells/L | 9.6 x 10^9 cells/L |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 48 | 28 / 100 |
| other Total, other adverse events | 0 / 48 | 0 / 100 |
| serious Total, serious adverse events | 0 / 48 | 0 / 100 |
Outcome results
Primary
Hospital Length of Stay (LOS)
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| N-Acetyl Glucosamine | Hospital Length of Stay (LOS) | 7 days |
| Control | Hospital Length of Stay (LOS) | 7.5 days |
p-value: 0.64395% CI: [-1, 3]Wilcoxon (Mann-Whitney)
p-value: 0.00195% CI: [-5.67, -2.87]Regression, Linear
Primary
Number of Participants Intubated During Hospitalization
The occurrence of intubation during hospitalization.
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-Acetyl Glucosamine | Number of Participants Intubated During Hospitalization | 8 Participants |
| Control | Number of Participants Intubated During Hospitalization | 25 Participants |
p-value: 0.29795% CI: [0.26, 1.48]Fisher Exact
p-value: 0.54195% CI: [0.19, 2.3]Regression, Logistic
Primary
Number of Participants Who Died During Hospitalization
The occurrence of death during hospitalization.
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-Acetyl Glucosamine | Number of Participants Who Died During Hospitalization | 6 Participants |
| Control | Number of Participants Who Died During Hospitalization | 28 Participants |
p-value: 0.03995% CI: [0.15, 0.91]Fisher Exact
p-value: 0.08195% CI: [0.09, 1.07]Regression, Logistic
Secondary
ICU Length of Stay
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| N-Acetyl Glucosamine | ICU Length of Stay | 2.5 days |
| Control | ICU Length of Stay | 9.0 days |
p-value: 0.09295% CI: [-1, 12]Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
The occurrence of intensive care unit (ICU) admission.
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-Acetyl Glucosamine | Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization | 11 Participants |
| Control | Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization | 36 Participants |
p-value: 0.13395% CI: [0.25, 1.19]Fisher Exact
Secondary
Number of Participants Who Experienced Hospice Initiation During Hospitalization
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.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-Acetyl Glucosamine | Number of Participants Who Experienced Hospice Initiation During Hospitalization | 0 Participants |
| Control | Number of Participants Who Experienced Hospice Initiation During Hospitalization | 4 Participants |
p-value: 0.14995% CI: [0, 1.52]Fisher Exact
Secondary
Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-Acetyl Glucosamine | Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization | 6 Participants |
| Control | Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization | 32 Participants |
p-value: 0.01595% CI: [0.12, 0.8]Fisher Exact
Secondary
Supplemental Oxygen Duration
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.
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| N-Acetyl Glucosamine | Supplemental Oxygen Duration | 7 days |
| Control | Supplemental Oxygen Duration | 7 days |
p-value: 0.83495% CI: [-2, 2]Wilcoxon (Mann-Whitney)