Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as abivertinib maleate, avitinib, AC0010, abivertinib
STI-5656 · 2 trials · 2 indications
Proportion of subjects whoa re alive and discharged from the hospital by Day 29
Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities: * Noninvasive positive pressure ventilation or continuous positive airway pressure * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥ 0.5) * Extracorporeal membrane oxygenation
| Arm | Type | Description |
|---|---|---|
| STI-5656 | EXPERIMENTAL | STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules administered orally daily for 7 days, in addition to standard of care |
| Abivertinib with Standard of Care | EXPERIMENTAL | STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care |
| Standard of Care | ACTIVE_COMPARATOR | Standard of care treatments for COVID-19 as determined appropriate by the Investigator |
| Name | Type | Description |
|---|---|---|
| STI-5656 | DRUG | STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. |
| Placebo | DRUG | Placebo capsules |
| Abivertinib | DRUG | Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days. |
| Standard of Care | OTHER | Standard of Care as determined by the Investigator |
Inclusion Criteria: * Confirmed positive for COVID-19 by RT-PCR assay or equivalent * Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board (IRB) or independent ethics committee (IEC) approved consent form prior to parti...