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

Primary Purpose

SARS-CoV-2 Infection

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BTL-TML-COVID

Placebo

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring Treatment for COVID-19

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

40 years of age or older
Provide written informed consent
Have a SARS-COV-19 diagnostic test with positive results

Exclusion Criteria:

Having an oxygen saturation level below 92% at baseline or currently on Oxygen therapy
Subjects currently hospitalized
Subjects who have received a COVID vaccination
Subjects with a diagnosis of immunodeficiency

Sites / Locations

Intermountain Clinical Reserach

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BTL-TML-COVID

Placebo

Arm Description

BTL-TML-COVID

Placebo

Outcomes

Primary Outcome Measures

Mean duration and severity of disease

Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument

Secondary Outcome Measures

Incidence/Safety of Adverse Events

AEs will be assessed by the investigator as to severity, duration and relationship to treatment

Full Information

NCT ID

NCT04522830

First Posted

August 18, 2020

Last Updated

April 9, 2021

Sponsor

Beech Tree Labs, Inc.

Collaborators

Norwich Clinical Research Associates Ltd., Curavit Clinical Research

1. Study Identification

Unique Protocol Identification Number

NCT04522830

Brief Title

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

Acronym

BTL-TML-COVID

Official Title

A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

July 30, 2020 (Actual)

Primary Completion Date

February 28, 2021 (Actual)

Study Completion Date

February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beech Tree Labs, Inc.

Collaborators

Norwich Clinical Research Associates Ltd., Curavit Clinical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2 Infection

Keywords

Treatment for COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BTL-TML-COVID

Arm Type

Experimental

Arm Description

BTL-TML-COVID

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

BTL-TML-COVID

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean duration and severity of disease

Description

Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument

Time Frame

Two days

Secondary Outcome Measure Information:

Title

Incidence/Safety of Adverse Events

Description

AEs will be assessed by the investigator as to severity, duration and relationship to treatment

Time Frame

Baseline through 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 40 years of age or older Provide written informed consent Have a SARS-COV-19 diagnostic test with positive results Exclusion Criteria: Having an oxygen saturation level below 92% at baseline or currently on Oxygen therapy Subjects currently hospitalized Subjects who have received a COVID vaccination Subjects with a diagnosis of immunodeficiency

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Duane Harris, MD

Organizational Affiliation

Intermountain Clinical Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lee Truax-Bellows

Organizational Affiliation

Norwich Clinical Research Associates (NCRA)

Official's Role

Study Director

Facility Information:

Facility Name

Intermountain Clinical Reserach

City

Draper

State/Province

Utah

ZIP/Postal Code

84020

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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