A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in patients with mild to moderate COVID 19 disease and low risk of disease progression (the "ACLR8-LR" study).
The TQ 2020\_08 study is a double-blind placebo-controlled, Phase 2b clinical trial that plans to enroll approximately 148 non-hospitalized patients with mild to moderate COVID 19 disease and low risk of disease progression (the "ACLR8-LR" study). Patients will undergo a brief screening period before being randomized to receive either self-administered 200 mg tafenoquine or matching placebo for up to 38 days. Following the treatment period, patients will have a follow up visit at study Day 42. The study's primary efficacy endpoint is time to sustained clinical recovery from COVID-19 symptoms (4 uninterrupted days of aggregate symptom scores ≤ 2) through Day 28 (± 2 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
148
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.
Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.
Time to sustained clinical recovery from COVID-19 symptoms (4 uninterrupted days of aggregate symptom scores ≤ 2) through Day 28 (± 2 days)
Time frame: Day 28 (± 2 days)
MCP-1 levels at Days 5, 14 (± 1 day) and 28 (± 2 days)
Time frame: Days 5, 14 (± 1 day) and 28 (± 2 days)
Day 5 aggregate symptom score (FDA's 14 COVID-19 symptoms)
Time frame: Day 5
Time to clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 for at least 1, 2 or 3 occasions) of all COVID-19 symptoms through Day 28 (± 2 days)
Time frame: Day 28 (± 2 days)
Time to sustained clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 for at least 1, 2, 3, or 4 occasions) of all COVID-19 symptoms through Days 14 (± 1 day) and 42 (± 2 days)
Time frame: Days 14 (± 1 day) and 42 (± 2 days)
Proportion of patients with sustained clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 on at least 1, 2, or 3 or 4 occasions) of all COVID-19 symptoms at Days 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
Time frame: Days 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
Time to first instance of clinical recovery from fever, cough, and shortness of breath at 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1 (recovery defined as in Dow and Smith 2022)
Time frame: 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
Proportion of patients recovered (first instance) from cough, fever, and shortness of breath at Day 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1 (recovery defined as in Dow and Smith 2022)
Time frame: Day 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
Time to sustained recovery (two, three or four uninterrupted days of recovery) from fever, cough, and shortness of breath at 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1
Time frame: 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
Proportion of patients recovered (sustained recovery for two, three or four uninterrupted days) from cough, fever, and shortness of breath at Day 14 (± 1 day), Day 28 (± 1 day) and 42 (± 2 days) who reported at least one such symptom on Day 1
Time frame: Day 14 (± 1 day), Day 28 (± 1 day) and 42 (± 2 days)
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