NCT04522830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

August 18, 2020

Last Update Submit

April 9, 2021

Conditions

SARS-CoV-2 Infection

Keywords

Treatment for COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Incidence/Safety of Adverse Events

    Baseline through 10 days

Study Arms (2)

BTL-TML-COVID

EXPERIMENTAL

BTL-TML-COVID

Drug: BTL-TML-COVID

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

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.

BTL-TML-COVID
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.

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Provide written informed consent
  • Have a SARS-COV-19 diagnostic test with positive results

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Clinical Reserach

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Duane Harris, MD

    Intermountain Clinical Research

    PRINCIPAL INVESTIGATOR

  • Lee Truax-Bellows

    Norwich Clinical Research Associates (NCRA)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 21, 2020

Study Start

July 30, 2020

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)