SARS-CoV-2 Infection
Conditions
Keywords
Treatment for COVID-19
Brief 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.
Interventions
DRUGBTL-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.
DRUGPlacebo
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.
Sponsors
Norwich Clinical Research Associates Ltd.
Curavit Clinical Research
Beech Tree Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean duration and severity of disease | Two days | Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence/Safety of Adverse Events | Baseline through 10 days | AEs will be assessed by the investigator as to severity, duration and relationship to treatment |
Countries
United States
Outcome results
None listed