Sorrento Therapeutics Inc (SRNE)

[cheynew]

Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19

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

Sponsors
Lead Sponsor: Sorrento Therapeutics, Inc.

Source Sorrento Therapeutics, Inc.
Brief Summary
A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19

Detailed Description
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.

Overall Status Not yet recruiting
Start Date September 2020
Completion Date May 2021
Primary Completion Date May 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of subjects discharged from hospital Randomization through Day 29
Secondary Outcome
Measure Time Frame
Incidence of adverse events (safety) Randomization through study completion through Day 36
Time to hospital admission, treatment, and discharge Randomization through study completion through Day 36
Number of days hospitalized Randomization to Day 36
Change in clinical status as assessed using a 0-8 ordinal scale Randomization to Day 3, Day 10, and Day 36
Change in RT-PCR test results Randomization to Day 3, Day 10, and Day 36
Change in C-reactive protein levels Randomization to Day 3 and Day 10
AUC of STI-5656 (PK) Randomization through Day 8
Cmax of STI-5656 (PK) Randomization through Day 8
t½ of STI-5656 (PK) Randomization through Day 8
Change in cytokine levels Randomization to Day 3 and Day 10
Tmax of STI-5656 (PK) Randomization through Day 8
Enrollment 400
Condition
Covid19
Intervention
Intervention Type: Drug

https://ichgcp.net/amp/clinical-trials-registry/NCT04528667