28
Participants
Start Date
July 30, 2020
Primary Completion Date
February 28, 2021
Study Completion Date
February 28, 2021
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
"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."
Intermountain Clinical Reserach, Draper
Lead Sponsor
Collaborators (2)
Norwich Clinical Research Associates Ltd.
OTHER
Curavit Clinical Research
UNKNOWN
Beech Tree Labs, Inc.
INDUSTRY