Covid19
Conditions
Keywords
covid-19
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.
Interventions
DRUGSTI-5656
STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
DRUGPlacebo
Placebo capsules
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| AUC of STI-5656 (PK) | Randomization through Day 8 | Area under the serum concentration-time curve (AUC) of STI-5656 |
Countries
Brazil
Outcome results
None listed