NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients

(COVGUT20 Trial)

Overseen By Elsa Wang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Notitia Biotechnologies Company

Must not be taking: Vancomycin, Broad-spectrum antibiotics

Disqualifiers: Celiac, IBD, IBS, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 28

Duration: 4 weeks

42 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving vancomycin monotherapy or oral broad-spectrum antibiotics.

What is the purpose of this trial?

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.

Research Team

Asa Oxner, MD

Principal Investigator

University of South Florida

Liping Zhao, PhD

Principal Investigator

Rutgers University

Eligibility Criteria

Inclusion Criteria

Aged between 18 to 79 (inclusive)

a) Mild COVID-19

Fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive NBT-NM108 to modulate gut microbiota for early-stage COVID-19 treatment

4 weeks

Visits at days 0, 14, and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Visits at days 28 and 56

Treatment Details

Interventions

• NBT-NM108

Participant Groups

Group I: NBT-NM108 + Usual Care Experimental Treatment 1 Intervention

Group II: Usual Care Only Active Control 1 Intervention

NBT-NM108 is already approved in United States for the following indications:

Approved in United States as NBT-NM108 for:

• COVID-19 in patients with type 2 diabetes and prediabetes

Who Is Running the Clinical Trial?

Notitia Biotechnologies Company

Lead Sponsor

Trials

1

Recruited

40+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+