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A Study in Adults to Test the Effects of Low Dose Thimerosal on Symptoms of COVID-19

NCT04522830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-04-13

No results posted yet for this study

Summary

Clinical trial to compare sublingual low does thimerosal in adults that have symptoms of SARS-CoV-2 Infection against placebo to show a difference in physical characteristics and viral levels.

Conditions

Interventions

DRUG

BTL-TML-COVID

Sublingual dosing of BTL-TML-COVID on days 1 and 2 - Day 1 - 1 drop every 15 minutes for the first hour of initiation of treatment then every hour for the balance of the day until bedtime. Day 2 - 1 drop every 2-3 hours for a total of 6 times during the day. The parallel group assignment will only be maintained until the completion of a minimum of 48 hours of blinded study drug dosing, at which point all subjects will receive the active treatment. Day 3 - 1 drop every 15 mins for the first hour of the day, then every hour for the balance of the day until bedtime. Days 4 through 10 - 1 drop every 3-4 hours for a total of four times during the day.

DRUG

Placebo

Sublingual dosing of matching placebo on days 1 and 2 - Day 1 - 1 drop every 15 minutes for the first hour of initiation of treatment then every hour for the balance of the day until bedtime. Day 2 - 1 drop every 2-3 hours for a total of 6 times during the day. The parallel group assignment will only be maintained until the completion of a minimum of 48 hours of blinded study drug dosing, at which point all subjects will receive the active treatment. Day 3 - 1 drop every 15 mins for the first hour of the day, then every hour for the balance of the day until bedtime. Days 4 through 10 - 1 drop every 3-4 hours for a total of four times during the day.

Sponsors & Collaborators

  • Norwich Clinical Research Associates Ltd.

    collaborator OTHER

  • Curavit Clinical Research

    collaborator UNKNOWN

  • Beech Tree Labs, Inc.

    lead INDUSTRY

Principal Investigators

  • Duane Harris, MD · Intermountain Clinical Research

  • Lee Truax-Bellows · Norwich Clinical Research Associates (NCRA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2021-02-28
Completion
2021-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04522830 on ClinicalTrials.gov