CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
NBT-NM108 +1 moredrug
Likely dose
NBT-NM108 30 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04540406
NCT04540406Phase 2Completed
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Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients

Notitia Biotechnologies Company·interventional·Posted Sep 7, 2020·Updated Oct 8, 2024

In Brief

A Phase 2 clinical trial evaluating NBT-NM108 and Usual Care Only for Suspected or Confirmed COVID-19. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuspected or Confirmed COVID-19
CountriesUnited States
CollaboratorsUniversity of South Florida, Rutgers University

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 7, 2020
Enrollment StartNov 2, 2021
Primary CompletionMar 14, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.8 years ago

Interventions

NBT-NM108drug

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.

Usual Care Onlyother

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