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

NCT04540406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-10-08

Study results available
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Summary

This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.

Conditions

  • Suspected or Confirmed COVID-19

Interventions

DRUG

NBT-NM108

Taken in the form of drinks four times a day (before each main meal and 2 hours after dinner) for 28 days. Each drink is prepared by mixing one sachet (30 g) with 500 ml of water.

OTHER

Usual Care Only

Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.

Sponsors & Collaborators

  • University of South Florida

    collaborator OTHER

  • Rutgers University

    collaborator OTHER

  • Notitia Biotechnologies Company

    lead INDUSTRY

Principal Investigators

  • Asa Oxner, MD · University of South Florida

  • Liping Zhao, PhD · Rutgers University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2022-03-14
Completion
2022-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04540406 on ClinicalTrials.gov