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| Name | Class |
|---|---|
| Norwich Clinical Research Associates Ltd. | OTHER |
| Curavit Clinical Research | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-TML-COVID | Experimental | BTL-TML-COVID |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-TML-COVID | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duane Harris, MD | Intermountain Clinical Research | Principal Investigator |
| Lee Truax-Bellows | Norwich Clinical Research Associates (NCRA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Clinical Reserach | Draper | Utah | 84020 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2023 | Aug 28, 2023 | 10 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo | 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. |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |