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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2021-02-28

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.

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Detailed Description

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Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BTL-TML-COVID

Group Type EXPERIMENTAL

BTL-TML-COVID

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No