NBT-NM108 for Coronavirus

(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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new botanical drug called NBT-NM108 (also known as Guild:Plus) to determine its effectiveness in treating early-stage COVID-19 symptoms by influencing gut health. Participants will receive either usual care or usual care plus this new treatment to compare outcomes. Suitable candidates have mild to moderate COVID-19 symptoms, such as fever, cough, or fatigue, and can use a smartphone or computer. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that NBT-NM108 is likely to be safe for humans?

Research shows that NBT-NM108, a new plant-based drug, looks promising in early studies. In one study, participants consumed muffins containing NBT-NM108 (30 grams each) for four weeks, with a dosage of two muffins a day. The study found no major safety issues, suggesting the treatment is well-tolerated. Another study found that NBT-NM108 increased beneficial gut bacteria, which might help with symptoms.

This trial is in Phase 2, indicating it has already been tested in humans for safety. This phase focuses on finding the right dose and checking for side effects. While more information is needed, earlier studies suggest NBT-NM108 is generally safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Unlike the standard care options for COVID-19, which often include antivirals like Remdesivir or monoclonal antibodies, NBT-NM108 offers a fresh approach. This treatment is unique because it uses a new active ingredient aimed at early intervention in symptomatic patients. Researchers are excited about NBT-NM108 because it has the potential to stop the virus in its tracks before it can cause severe symptoms, which could significantly reduce the impact of COVID-19. Additionally, it is designed to work in conjunction with usual care, potentially enhancing overall treatment effectiveness.

What evidence suggests that NBT-NM108 could be an effective treatment for early-stage COVID-19?

Research shows that NBT-NM108, a plant-based drug, might help treat early-stage COVID-19 by affecting gut bacteria. In this trial, some participants will receive NBT-NM108 alongside usual care. This treatment has shown promise in easing stomach and digestive issues in patients with severe cases. Other studies have demonstrated that NBT-NM108 reduces diarrhea caused by chemotherapy in colon cancer patients, suggesting it benefits gut health. While its effectiveness against COVID-19 is still under investigation, its ability to improve gut health could help manage early symptoms of the virus. Overall, the treatment appears promising, but more research is needed to confirm its effectiveness for COVID-19 specifically. ^{3 6 7 8 9}

Who Is on the Research Team?

Asa Oxner, MD

Principal Investigator

University of South Florida

Liping Zhao, PhD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• NBT-NM108

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04540406?tab=results

Study Results | NBT-NM108 as an Early Treatment for Suspected ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9040862/

Nutritional Modulation of Gut Microbiota Alleviates Severe ... Both the physician and the patient agreed to the hypothesis that NBT-NM108 may alleviate post-acute COVID-19 syndrome. This single-patient ...

3. withpower.com withpower.com/trial/phase-2-stage-ivb-colon-cancer-ajcc-v8-3-2022-da65d

High Dietary Fiber Formula for Colon Cancer This phase II trial tests whether NBT-NM108 works in reducing chemotherapy-induced diarrhea in patients with colon cancer that has spread to other places in ...

4. research.rutgers.edu research.rutgers.edu/news/new-formula-developed-rutgers-researcher-proves-promising-alleviating-gastrointestinal

New Formula Developed by Rutgers Researcher Proves ... The results, now published, establish that the high intake of the NBT-NM108 formula significantly alleviated her severe GI symptoms and other ...

5. trial.medpath.com trial.medpath.com/clinical-trial/89be5ea837baeda2/nct04540406-modulation-gut-microbiota-nbt-nm108-treatment-covid-19

NBT-NM108 as an Early Treatment for Suspected or Confirmed ... This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based ...

6. withpower.com withpower.com/trial/phase-2-multiple-sclerosis-2021-f1fd7

High-Fiber Supplement for Multiple Sclerosis This Phase 1 & 2 medical study run by Suhayl Dhib-Jalbut, MD needs participants to evaluate whether NBT-NM108 will have tolerable side effects & efficacy ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04574024

HFS (High-Fiber Supplement) in MS (Multiple Sclerosis) His recent study has suggested an association between intake of NBT-NM108 and increased abundance of short-chain fatty acid (SCFA)-producing gut bacteria.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05541003?tab=results

Study Results | NCT05541003 | Understanding the Role of ... All participants will receive NBT-NM108 prepared as muffin (each contains 30 g of the product) for 4 weeks. The dosage will be 2 muffins a day. This dosage of ...

9. notitiabio.com notitiabio.com/investors.html

Investors & News The trial achieved its primary endpoint ahead of schedule, demonstrating that NBT-NM108 effectively promotes the gut bacteria Amplicon Sequence Variants (ASVs) ...