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Botanical-based drug

NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients (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 weeks
Treatment ~ Varies
Follow Up ~at days 0, 14, 28, and 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 0, 14, 28, and 56 for reporting.

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 more

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
191,797 Total Patients Enrolled
Rutgers UniversityOTHER
121 Previous Clinical Trials
2,809,312 Total Patients Enrolled
Asa Oxner, MDPrincipal InvestigatorUniversity of South Florida
Liping Zhao, PhDPrincipal InvestigatorRutgers University
1 Previous Clinical Trials
19 Total Patients Enrolled
~10 spots leftby Dec 2025
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