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Botanical-based drug
NBT-NM108 for Coronavirus (COVGUT20 Trial)
Phase 2
Waitlist Available
Led By Asa Oxner, MD
Research Sponsored by Notitia Biotechnologies Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at days 0, 14, 28, and 56
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new plant-based drug called NBT-NM108. It aims to help early-stage COVID-19 patients by changing the balance of bacteria in their gut. The goal is to see if this can improve their symptoms and recovery.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at days 0, 14, 28, and 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 0, 14, 28, and 56
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amplicon Sequence Variants (ASVs) That Are Significantly Correlated With Variation in the Microbiome Data Between NBT-NM108 Group and Usual Care Only Group From Day 0 to 28
Secondary study objectives
Illness Severity Based on the Categorization From FDA and World Health Organization COVID-19 Guidance Document
Number of Participants That Were Hospitalized or Died From COVID19
Proportion of Participants Who Are "Alive and Not Admitted to the Hospital"
+3 moreSide effects data
From 2022 Phase 2 trial • 42 Patients • NCT0454040619%
Mild adverse events
100%
80%
60%
40%
20%
0%
Study treatment Arm
NBT-NM108 + Usual Care
Usual Care Only
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NBT-NM108 + Usual CareExperimental Treatment1 Intervention
Group II: Usual Care OnlyActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NBT-NM108
2023
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Notitia Biotechnologies CompanyLead Sponsor
University of South FloridaOTHER
426 Previous Clinical Trials
192,027 Total Patients Enrolled
Rutgers UniversityOTHER
118 Previous Clinical Trials
2,805,272 Total Patients Enrolled
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