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

Study Overview
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Brief Summary
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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.

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

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: BTL-TML-COVID
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTL-TML-COVID<br>BTL-TML-COVID | Drug: BTL-TML-COVID<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence/Safety of Adverse Events | AEs will be assessed by the investigator as to severity, duration and relationship to treatment | Baseline through 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment for COVID-19