Phase 2
Completed N=96
Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19
Source: ClinicalTrials.gov NCT04440007 ↗Enrolled (actual)
96
Serious AEs
18.1%
Results posted
Jan 2023
Primary outcomePrimary: Percentage of Subjects Alive and Free of Respiratory Failure at Day 28 — 40; 38 Participants
Summary
Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Alive and Free of Respiratory Failure at Day 28 |
40; 38 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
31; 23 | — |
| SECONDARY Percentage of Subjects Alive and Free of Respiratory Failure at Day 60 |
37; 35 | — |
| SECONDARY Change in C-Reactive Protein (CRP) |
71.43; 66.67 | — |
| SECONDARY Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2) |
210.61; 253.34 | — |
| SECONDARY All-cause Mortality at Day 60 and Day 90 |
8; 5; 8; 5 | — |
| SECONDARY Number of Days Alive Outside of Hospital up to Day 28 |
16.7; 17.1 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed infection with SARS-CoV-2 per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization
- Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen saturation 2x ULN
- QTcF prolongation >480 milliseconds
- Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
- Treatment with a strong cytochrome P450 (CYP3A4 inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug)
- Received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, BTK inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
- Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
- Any condition that confounds the ability to interpret data from the study
- Relevant renal impairment (eGFR <60 mL/min)
- Any significant medical condition, laboratory abnormality or psychiatric illness that would interfere or prevent the subject from participating in the study
Data sourced from ClinicalTrials.gov (NCT04440007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.