Covid19Phase 2NCT04528667
Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19
A Phase 2 study testing STI-5656 in people with Covid19, run by Sorrento Therapeutics, Inc. at 1 site in Brazil.
Trial summary
A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- STI-5656
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jan 2021to 7 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19
Read the 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.
- Conditions
- Covid19
- Being tested
- STI-5656, Placebo
- Keywords
- covid-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-5656Drug
Also called abivertinib maleate, avitinib, AC0010, abivertinib
STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
PlaceboDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| STI-5656 | Experimental | STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care Receives: Drug: STI-5656 |
| Placebo | Placebo comparator | Placebo capsules administered orally daily for 7 days, in addition to standard of care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects discharged from hospital
Proportion of subjects whoa re alive and discharged from the hospital by Day 29
Measured: Randomization through Day 29
Secondary outcomes (11)
Incidence of adverse events (safety)
Types, frequencies, and severities of adverse events and their relationships to STI-5656, including serious adverse events
Measured: Randomization through study completion through Day 36
Time to hospital admission, treatment, and discharge
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
Measured: Randomization through study completion through Day 36
Number of days hospitalized
Number of days hospitalized from randomization through Day 36
Measured: Randomization to Day 36
Change in clinical status as assessed using a 0-8 ordinal scale
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
Measured: Randomization to Day 3, Day 10, and Day 36
Change in RT-PCR test results
Change in RT-PCR test results (or equivalent) at Days 3, 10, and 36
Measured: Randomization to Day 3, Day 10, and Day 36
Change in C-reactive protein levels
Change in C-reactive protein (CRP) levels at Day 3 and Day 10
Measured: Randomization to Day 3 and Day 10
AUC of STI-5656 (PK)
Area under the serum concentration-time curve (AUC) of STI-5656
Measured: Randomization through Day 8
Cmax of STI-5656 (PK)
Maximum observed serum concentration (Cmax) of STI-5656
Measured: Randomization through Day 8
t½ of STI-5656 (PK)
Apparent serum terminal elimination half life (t½) of STI-5656
Measured: Randomization through Day 8
Change in cytokine levels
Change in cytokine levels (including IL-6, TNF-a, IFNγ, IL1β) at Day 3 and Day 10
Measured: Randomization to Day 3 and Day 10
Tmax of STI-5656 (PK)
Time to Cmax (Tmax) of STI-5656
Measured: Randomization through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start6 Jan 2021
- Primary completion23 Aug 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528667
- Sponsor's protocol ID
- BTK-COV-202BR
- Status last verified
- Nov 2021
- First submitted
- 20 Aug 2020
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04528667
- Acronym / sponsor ID
- BTK-COV-202BR
- Conditions
- Covid19
- Keywords
- covid-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STI-5656 | Experimental | Drug: STI-5656STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules administered orally daily for 7 days, in addition to standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STI-5656Also: abivertinib maleate, avitinib, AC0010, abivertinibSTI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. | Drug | STI-5656 |
| PlaceboPlacebo capsules | Drug | Placebo |
Primary outcome
Proportion of subjects discharged from hospital
Time frame: Randomization through Day 29
Proportion of subjects whoa re alive and discharged from the hospital by Day 29
11 secondary outcomes
Incidence of adverse events (safety)
Time frame: Randomization through study completion through Day 36
Time to hospital admission, treatment, and discharge
Time frame: Randomization through study completion through Day 36
Number of days hospitalized
Time frame: Randomization to Day 36
Change in clinical status as assessed using a 0-8 ordinal scale
Time frame: Randomization to Day 3, Day 10, and Day 36
Change in RT-PCR test results
Time frame: Randomization to Day 3, Day 10, and Day 36
Change in C-reactive protein levels
Time frame: Randomization to Day 3 and Day 10
AUC of STI-5656 (PK)
Time frame: Randomization through Day 8
Cmax of STI-5656 (PK)
Time frame: Randomization through Day 8
t½ of STI-5656 (PK)
Time frame: Randomization through Day 8
Change in cytokine levels
Time frame: Randomization to Day 3 and Day 10
Tmax of STI-5656 (PK)
Time frame: Randomization through Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STI-5656 in people with Covid19, run by Sorrento Therapeutics, Inc. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects discharged from hospital (time frame: Randomization through Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.