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

Purpose

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.

Condition

  • SARS-CoV-2 Infection

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BTL-TML-COVID 		BTL-TML-COVID
  • 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 Comparator
Placebo 		Placebo
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04522830
Status
Completed
Sponsor
Beech Tree Labs, Inc.