Status:
COMPLETED
Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19
Lead Sponsor:
Sorrento Therapeutics, Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2021
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT04528667
Start Date
January 6 2021
End Date
October 7 2021
Last Update
November 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital e Maternidade Christovão da Gama
Santo André, São Paulo, Brazil