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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522830
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Norwich Clinical Research Associates Ltd.
Curavit Clinical Research
Information provided by (Responsible Party):
Beech Tree Labs, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: BTL-TML-COVID Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection
Actual Study Start Date : July 30, 2020
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Thimerosal

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522830


Locations
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United States, Utah
Intermountain Clinical Reserach
Draper, Utah, United States, 84020
Sponsors and Collaborators
Beech Tree Labs, Inc.
Norwich Clinical Research Associates Ltd.
Curavit Clinical Research
Investigators
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Principal Investigator: Duane Harris, MD Intermountain Clinical Research
Study Director: Lee Truax-Bellows Norwich Clinical Research Associates (NCRA)
More Information
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Responsible Party: Beech Tree Labs, Inc.
ClinicalTrials.gov Identifier: NCT04522830    
Other Study ID Numbers: 2020-04-0311
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beech Tree Labs, Inc.:
Treatment for COVID-19
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases