Clinical trial NCT04528667: Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects discharged from hospital
timeFrame: Randomization through Day 29
Secondary outcomes:
measure: Incidence of adverse events (safety)
timeFrame: Randomization through study completion through Day 36
measure: Time to hospital admission, treatment, and discharge
timeFrame: Randomization through study completion through Day 36
measure: Number of days hospitalized
timeFrame: Randomization to Day 36
measure: Change in clinical status as assessed using a 0-8 ordinal scale
timeFrame: Randomization to Day 3, Day 10, and Day 36
measure: Change in RT-PCR test results
timeFrame: Randomization to Day 3, Day 10, and Day 36
measure: Change in C-reactive protein levels
timeFrame: Randomization to Day 3 and Day 10
measure: AUC of STI-5656 (PK)
timeFrame: Randomization through Day 8
measure: Cmax of STI-5656 (PK)
timeFrame: Randomization through Day 8
measure: t½ of STI-5656 (PK)
timeFrame: Randomization through Day 8
measure: Change in cytokine levels
timeFrame: Randomization to Day 3 and Day 10
measure: Tmax of STI-5656 (PK)
timeFrame: Randomization through Day 8
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Hospital e Maternidade Christovão da Gama
state: SP
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References: