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Completed

NCT Number: NCT04522830

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

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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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Intermountain Clinical Reserach

Draper, Utah, 84020, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean duration and severity of disease

    Time frame: Two days

    Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument

Secondary outcomes

  1. Incidence/Safety of Adverse Events

    Time frame: Baseline through 10 days

    AEs will be assessed by the investigator as to severity, duration and relationship to treatment

Sponsors and collaborators

Lead sponsor

Beech Tree Labs, Inc.

Industry

Collaborators

  • Curavit Clinical Research
  • Norwich Clinical Research Associates Ltd.

Registry information

Official study title

A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection

Acronym: BTL-TML-COVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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