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

SARS-CoV-2 Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522830
• Other study ID #: 2020-04-0311
• Status: Completed
• Phase: Phase 2
• Start date: July 30, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2021
• Source: Beech Tree Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• SARS-CoV-2 Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Intermountain Clinical Reserach	Draper	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Beech Tree Labs, Inc.	Curavit Clinical Research, Norwich Clinical Research Associates Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean duration and severity of disease	Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument	Two days
Secondary	Incidence/Safety of Adverse Events	AEs will be assessed by the investigator as to severity, duration and relationship to treatment	Baseline through 10 days