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

Phase 2

Completed

• Conditions: Covid19
• Interventions: Drug: STI-5656; Drug: Placebo

• Registration Number: NCT04528667
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-27
• Study Start: 2021-01-06
• Primary Completion: 2021-08-23
• Study Completion: 2021-10-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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 participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27, 2020 (Updated on July 2, 2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used
• Able to swallow capsules
• Willing to follow contraception guidelines

Exclusion Criteria

• Pregnant or breast feeding
• Suspected uncontrolled active bacterial, fungal, viral, or other infection other than COVID-19
• Treatment with a strong cytochrome p450 3A4 inhibitor or inducer within 7 days prior to Day 1
• Received anti-rejection or immunomodulatory drugs within 14 days prior to Day 1
• Concurrent participation in another clinical trial involving therapeutic interventions (observation studies are acceptable)
• Any condition that confounds the ability to interpret data from the study
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere with or prevent the subject from participating in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STI-5656	STI-5656	STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care
Placebo	Placebo	Placebo capsules administered orally daily for 7 days, in addition to standard of care

Primary Outcome Measures

Name	Time	Method
Proportion of subjects discharged from hospital	Randomization through Day 29	Proportion of subjects whoa re alive and discharged from the hospital by Day 29

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (safety)	Randomization through study completion through Day 36	Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events
Time to hospital admission, treatment, and discharge	Randomization through study completion through Day 36	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
Number of days hospitalized	Randomization to Day 36	Number of days hospitalized from randomization through 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 clinical status as assessed using a 0-8 ordinal scale, where a lower score equals better outcome, at Days 3, 10, and 36
Change in RT-PCR test results	Randomization to Day 3, Day 10, and Day 36	Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36
Change in C-reactive protein levels	Randomization to Day 3 and Day 10	Change in C-reactive protein (CRP) levels at Day 3 and Day 10
AUC of STI-5656 (PK)	Randomization through Day 8	Area under the serum concentration-time curve (AUC) of STI-5656
Cmax of STI-5656 (PK)	Randomization through Day 8	Maximum observed serum concentration (Cmax) of STI-5656
t½ of STI-5656 (PK)	Randomization through Day 8	Apparent serum terminal elimination half life (t½) of STI-5656
Change in cytokine levels	Randomization to Day 3 and Day 10	Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10
Tmax of STI-5656 (PK)	Randomization through Day 8	Time to Cmax (Tmax) of STI-5656

Trial Locations

Locations (1)

Hospital e Maternidade Christovão da Gama; 🇧🇷 Santo André, SP, Brazil