A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19
This is a phase 2, randomized, double-blind, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19 in Brazil. Subjects are randomized 3:1 STI-5656 to placebo. Subjects receive either 100 mg of STI-5656 or placebo daily for 7 days. Standard of care will be maintained for all subjects throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
396
Hospital e Maternidade Christovão da Gama
Santo André, São Paulo, Brazil
Proportion of subjects discharged from hospital
Proportion of subjects whoa re alive and discharged from the hospital by Day 29
Time frame: Randomization through Day 29
Incidence of adverse events (safety)
Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events
Time frame: Randomization through study completion through Day 36
Time to hospital admission, treatment, and discharge
Time from onset of COVID-19 symptoms to hospital admission, time from hospitalization to start of treatment (D1), and time from D1 to hospital discharge
Time frame: Randomization through study completion through Day 36
Number of days hospitalized
Number of days hospitalized from randomization through Day 36
Time frame: Randomization to Day 36
Change in clinical status as assessed using a 0-8 ordinal scale
Change in clinical status as assessed using a 0-8 ordinal scale, where a lower score equals better outcome, at Days 3, 10, and 36
Time frame: Randomization to Day 3, Day 10, and Day 36
Change in RT-PCR test results
Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36
Time frame: Randomization to Day 3, Day 10, and Day 36
Change in C-reactive protein levels
Change in C-reactive protein (CRP) levels at Day 3 and Day 10
Time frame: Randomization to Day 3 and Day 10
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AUC of STI-5656 (PK)
Area under the serum concentration-time curve (AUC) of STI-5656
Time frame: Randomization through Day 8
Cmax of STI-5656 (PK)
Maximum observed serum concentration (Cmax) of STI-5656
Time frame: Randomization through Day 8
t½ of STI-5656 (PK)
Apparent serum terminal elimination half life (t½) of STI-5656
Time frame: Randomization through Day 8
Change in cytokine levels
Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10
Time frame: Randomization to Day 3 and Day 10
Tmax of STI-5656 (PK)
Time to Cmax (Tmax) of STI-5656
Time frame: Randomization through Day 8