Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    beech tree labs

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522830
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborators:
Norwich Clinical Research Associates Ltd.
Curavit Clinical Research
Information provided by (Responsible Party):
Beech Tree Labs, Inc.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Thimerosal

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.





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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Tom Hatch (859) 272-9915 thatch@beechtreelabs.com

Locations
Layout table for location information
United States, Utah
Intermountain Clinical Reserach Recruiting
Draper, Utah, United States, 84020
Contact: DeAnn Sims    801-553-2379    deann@icrtrials.com   
Principal Investigator: Duane Harris, MD         
Sponsors and Collaborators
Beech Tree Labs, Inc.
Norwich Clinical Research Associates Ltd.
Curavit Clinical Research
Investigators
Layout table for investigator information
Principal Investigator: Duane Harris, MD Intermountain Clinical Research
Study Director: Lee Truax-Bellows Norwich Clinical Research Associates (NCRA)
Layout table for additonal information
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: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Infection