Title
A Study in Adults to Test the Effects of Low Dose Thimerosal on Symptoms of COVID-19
A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection
Phase
Phase 2Lead Sponsor
Beech Tree Labs, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
SARS-CoV-2 InfectionIntervention/Treatment
BTL-TML-COVID ...Study Participants
28Clinical 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.
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.
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.
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