Phase 1
N=150
N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Coronavirus · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04706416 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants Intubated During Hospitalization — 8; 25 Participants — p=0.297
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- N-acetyl glucosamine (NAG) (Dietary_supplement); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Quantinosis.ai LLC
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Intubated During Hospitalization |
8; 25 | 0.297 |
| PRIMARY Number of Participants Who Died During Hospitalization |
6; 28 | 0.039 sig |
| PRIMARY Hospital Length of Stay (LOS) |
7; 7.5 | 0.643 |
| SECONDARY Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization |
11; 36 | 0.133 |
| SECONDARY ICU Length of Stay |
2.5; 9.0 | 0.092 |
| SECONDARY Supplemental Oxygen Duration |
7; 7 | 0.834 |
| SECONDARY Number of Participants Who Experienced Hospice Initiation During Hospitalization |
0; 4 | 0.149 |
| SECONDARY Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization |
6; 32 | 0.015 sig |
Summary
This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04706416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.