SARS-CoV-2 InfectionPhase 2BTL-TML-COVIDNCT04522830
A Study in Adults to Test the Effects of Low Dose Thimerosal on Symptoms of COVID-19
A Phase 2 study testing BTL-TML-COVID in people with SARS-CoV-2 Infection, run by Beech Tree Labs, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- BTL-TML-COVID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to 28 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or older
- Provide written informed consent
- Have a SARS-COV-19 diagnostic test with positive results
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection
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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- BTL-TML-COVID, Placebo
- Keywords
- Treatment for COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-TML-COVIDDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BTL-TML-COVID | Experimental | BTL-TML-COVID Receives: Drug: BTL-TML-COVID |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration and severity of disease
Change from baseline in the physical component summary of the short form-36 Quality of Life Instrument
Measured: Two days
Secondary outcomes (1)
Incidence/Safety of Adverse Events
AEs will be assessed by the investigator as to severity, duration and relationship to treatment
Measured: Baseline through 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start30 Jul 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beech Tree Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Norwich Clinical Research Associates Ltd., Curavit Clinical Research
- Responsible party
- Sponsor
- Investigators
- Duane Harris, MD, Principal investigator, Intermountain Clinical ResearchLee Truax-Bellows, Study director, Norwich Clinical Research Associates (NCRA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522830
- Sponsor's protocol ID
- 2020-04-0311
- Acronym
- BTL-TML-COVID
- Status last verified
- Apr 2021
- First submitted
- 18 Aug 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Phase 2 Trial of Sublingual Low-Dose Thimerosal in Adults With Symptomatic SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04522830
- Acronym / sponsor ID
- BTL-TML-COVID / 2020-04-0311
- Conditions
- SARS-CoV-2 Infection
- Keywords
- Treatment for COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beech Tree Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Norwich Clinical Research Associates Ltd., Curavit Clinical Research
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTL-TML-COVID | Experimental | Drug: BTL-TML-COVIDBTL-TML-COVID |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years of age or older
- Provide written informed consent
- Have a SARS-COV-19 diagnostic test with positive results
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTL-TML-COVIDSublingual 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. | Drug | BTL-TML-COVID |
| PlaceboSublingual 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. | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Incidence/Safety of Adverse Events
Time frame: Baseline through 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duane Harris, MD principal investigator
Intermountain Clinical Research
Lee Truax-Bellows study director
Norwich Clinical Research Associates (NCRA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTL-TML-COVID in people with SARS-CoV-2 Infection, run by Beech Tree Labs, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean duration and severity of disease (time frame: Two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.