Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 11:45 AM
Study NCT ID:
NCT04706416
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2020-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000117', 'term': 'Acetylglucosamine'}], 'ancestors': [{'id': 'D005944', 'term': 'Glucosamine'}, {'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ameerehassan@gmail.com', 'phone': '973-303-8146', 'title': 'Dr. Ameer Hassan', 'organization': 'Valley Baptist Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': '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).', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Intubated During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.'}, {'id': 'OG001', 'title': 'Control', 'description': '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).'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.297', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.26', 'ciUpperLimit': '1.48', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.19', 'ciUpperLimit': '2.30', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of intubation during hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Died During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.'}, {'id': 'OG001', 'title': 'Control', 'description': '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).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.91', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.09', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of death during hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hospital Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.'}, {'id': 'OG001', 'title': 'Control', 'description': '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).'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '11.75'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '17'}]}]}], 'analyses': [{'pValue': '0.643', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '3.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β-coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.27', 'ciLowerLimit': '-5.67', 'ciUpperLimit': '-2.87', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.", 'description': 'The number of days the patient is hospitalized.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.'}, {'id': 'OG001', 'title': 'Control', 'description': '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).'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of intensive care unit (ICU) admission.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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\n10 treatment patients were admitted to the ICU and had ICU LOS data available.'}, {'id': 'OG001', 'title': 'Control', 'description': '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).\n\n36 control patients were admitted to the ICU and had ICU LOS data available.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '14.75'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '2.25', 'upperLimit': '21.50'}]}]}], 'analyses': [{'pValue': '0.092', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '12.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.", 'description': 'The number of days the patient is in the ICU.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Supplemental Oxygen Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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).'}, {'id': 'OG001', 'title': 'Control', 'description': '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).'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '12'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '15'}]}]}], 'analyses': [{'pValue': '0.834', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann estimator', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '2.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.", 'description': 'The duration of supplemental oxygen use.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Hospice Initiation During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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).'}, {'id': 'OG001', 'title': 'Control', 'description': '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).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.001', 'ciLowerLimit': '0', 'ciUpperLimit': '1.52', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.'}, {'id': 'OG001', 'title': 'Control', 'description': '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).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.80', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of either death or initiation of hospice proceedings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.'}, {'id': 'FG001', 'title': 'Control', 'description': '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).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No significant events in the study occurred after enrollment and prior to administration of the treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'N-Acetyl Glucosamine', '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\nN-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.'}, {'id': 'BG001', 'title': 'Control', 'description': '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).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '51.50', 'upperLimit': '72.25'}, {'value': '68', 'groupId': 'BG001', 'lowerLimit': '57.25', 'upperLimit': '76.75'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '53.25', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from symptom onset', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '7', 'upperLimit': '18.75'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '15.75'}, {'value': '8.5', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Disease severity', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'description': 'World Health Organization (WHO) COVID-19 Disease Severity Score https://www.who.int/publications/i/item/WHO-2019-nCoV-clinical-2021-1\n\nOne-time assessment at the time of hospital admission\n\n0 - not infected\n\n1. \\- mild illness (very few or mild symptoms)\n2. \\- mild illness (symptoms managed at home)\n3. \\- moderate illness (hospitalized, no supplemental oxygen)\n4. \\- moderate illness (hospitalized, supplemental oxygen)\n5. \\- severe illness (non-invasive breathing support)\n6. \\- severe illness (invasive breathing support)\n7. \\- severe illness (life-saving ventilation and organ support)\n8. \\- death', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Supplemental oxygen use', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'White blood cell (WBC)', 'classes': [{'categories': [{'measurements': [{'value': '8.65', 'groupId': 'BG000', 'lowerLimit': '6.05', 'upperLimit': '11.73'}, {'value': '10.25', 'groupId': 'BG001', 'lowerLimit': '6.73', 'upperLimit': '13.50'}, {'value': '9.6', 'groupId': 'BG002', 'lowerLimit': '6.33', 'upperLimit': '13.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'x 10^9 cells/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hematocrit (hct)', 'classes': [{'categories': [{'measurements': [{'value': '39.71', 'spread': '6.02', 'groupId': 'BG000'}, {'value': '37.97', 'spread': '7.93', 'groupId': 'BG001'}, {'value': '38.54', 'spread': '7.385', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of red blood cells', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin (Hb)', 'classes': [{'categories': [{'measurements': [{'value': '12.69', 'spread': '1.91', 'groupId': 'BG000'}, {'value': '12.10', 'spread': '2.61', 'groupId': 'BG001'}, {'value': '12.3', 'spread': '2.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Asthma', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Atrial fibrillation', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary artery disease', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic heart failure', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic obstructive pulmonary disease (COPD)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'End-stage renal disease (ESRD)', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hyperlipidemia', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Obesity', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive chest x-ray', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received antibiotics', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received antivirals', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received corticosteroids', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received convalescent plasma', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-26', 'size': 121502, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-26T15:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2020-12-31', 'resultsFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-02', 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Intubated During Hospitalization', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of intubation during hospitalization.'}, {'measure': 'Number of Participants Who Died During Hospitalization', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of death during hospitalization.'}, {'measure': 'Hospital Length of Stay (LOS)', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.", 'description': 'The number of days the patient is hospitalized.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of intensive care unit (ICU) admission.'}, {'measure': 'ICU Length of Stay', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.", 'description': 'The number of days the patient is in the ICU.'}, {'measure': 'Supplemental Oxygen Duration', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.", 'description': 'The duration of supplemental oxygen use.'}, {'measure': 'Number of Participants Who Experienced Hospice Initiation During Hospitalization', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.'}, {'measure': 'Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization', 'timeFrame': "Through study completion (duration of patient's hospitalization), an average of 7-10 days.", 'description': 'The occurrence of either death or initiation of hospice proceedings.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['N-acetyl glucosamine'], 'conditions': ['Coronavirus', 'Covid19']}, 'referencesModule': {'references': [{'pmid': '34306677', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* Treated with N-acetyl glucosamine (NAG) as first-line treatment\n* 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)\n* Clinically diagnosed with COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)\n* No intubation prior to hospitalization and enrollment in the current study.\n\nExclusion Criteria:\n\n* \\<18 years old upon admission\n* Allergy to NAG\n* Allergy to shellfish\n* Currently taking warfarin\n* Currently pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT04706416', 'briefTitle': 'N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quantinosis.ai LLC'}, 'officialTitle': 'N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)', 'orgStudyIdInfo': {'id': 'IRB #2020-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-Acetyl Glucosamine', '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).', 'interventionNames': ['Dietary Supplement: N-acetyl glucosamine (NAG)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'N-acetyl glucosamine (NAG)', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['N-Acetyl Glucosamine']}, {'name': 'Control', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78550', 'city': 'Harlingen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Baptist Medical Center', 'geoPoint': {'lat': 26.19063, 'lon': -97.6961}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will publish based on summary data, but make individual participant data available upon request. There are no plans to publish individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quantinosis.ai LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}