Covid-19Phase 2SOCNCT04440007

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

A Phase 2 study testing Abivertinib in people with Covid-19, run by Sorrento Therapeutics, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid-19
What is being tested?: Abivertinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 6 sitesUnited States
Study dates: 9 Oct 2020to 23 Aug 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 infection with SARS-CoV-2 per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization
Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen saturation <94% on room air or subject requires supplemental oxygen
Able to swallow capsules
Willing to follow contraception guidelines
Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board 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 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used

Who cannot join

Known cardio-pulmonary resuscitation within 14 days prior to randomization
Pregnant or breast feeding
Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN) and total bilirubin > 2x ULN
QTcF prolongation >480 milliseconds
Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll

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Treatment with a strong cytochrome P450 (CYP3A4 inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug)
Received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, BTK inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Any condition that confounds the ability to interpret data from the study
Relevant renal impairment (eGFR <60 mL/min)
Any significant medical condition, laboratory abnormality or psychiatric illness that would interfere or prevent the subject from participating in the study

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Alexandria Cardiology Clinic
Alexandria, Louisiana, 71301
Teradan Clinical Trials
Brandon, Florida, 33511
Memorial Hermann Memorial City Hospital
Houston, Texas, 77024
Clinical Trials of SWLA
Lake Charles, Louisiana, 70601
Quality Clinical Research
Omaha, Nebraska, 68114
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19

Read the detailed description

This is a Phase 2, open-label, randomized 2-arm multicenter study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) administered orally plus Standard of Care (SOC) versus SOC in hospitalized subjects with RT-PCR confirmed SARS-CoV-2 infection and COVID-19 pneumonia (documented radiographically). Only hospitalized patients are eligible for this study.

Conditions: Covid-19
Being tested: Abivertinib, Standard of Care
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AbivertinibDrug
Also called abivertinib maleate, avitinib, AC0010, STI-5656
Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.
Standard of CareOther
Standard of Care as determined by the Investigator

Study groups in NCT04440007
Study group	Role	What they receive
Abivertinib with Standard of Care	Experimental	STI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care Receives: Drug: Abivertinib; Other: Standard of Care
Standard of Care	Active comparator	Standard of care treatments for COVID-19 as determined appropriate by the Investigator Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Alive and Free of Respiratory Failure at Day 28
Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities:
- Noninvasive positive pressure ventilation or continuous positive airway pressure
- Endotracheal intubation and mechanical ventilation
- Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥ 0.5)
- Extracorporeal membrane oxygenation
Measured: Randomization to Day 28

Secondary outcomes (6)

Number of Participants With Treatment-emergent Adverse Events
Number of Participants with Treatment-emergent Adverse Events
Measured: Randomization through study completion to 94 days
Percentage of Subjects Alive and Free of Respiratory Failure at Day 60
Percentage of subjects alive and free of respiratory failure at Day 60
Measured: Randomization to Day 60
Change in C-Reactive Protein (CRP)
Mean change in CRP on Day 7
Measured: Day 7
Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)
PaO2/FiO2 at Day 1
Measured: Day 1
All-cause Mortality at Day 60 and Day 90
All-cause mortality at Day 60 and Day 90
Measured: Day 60 and Day 90
Number of Days Alive Outside of Hospital up to Day 28
Number of days alive outside of hospital up to Day 28
Measured: Randomization up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 202023 Aug 2021

First posted19 Jun 2020
Study start9 Oct 2020
Primary completion1 Jul 2021
Study completion23 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Covid-19Studies 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: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04440007
Sponsor's protocol ID: STI-5656-2001
Acronym: SOC
Status last verified: Dec 2022
First submitted: 17 Jun 2020
Last updated: 18 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19
ClinicalTrials.gov ID: NCT04440007
Acronym / sponsor ID: SOC / STI-5656-2001
Conditions: Covid-19
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 9 Oct 2020 (actual)
Primary completion: 1 Jul 2021 (actual)
Study completion: 23 Aug 2021 (actual)
First posted: 19 Jun 2020 (actual)
Results: Posted 18 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Abivertinib with Standard of Care	Experimental	Drug: Abivertinib, Other: Standard of CareSTI-5656 (abivertinib maleate) capsule administered orally 200 mg QD up to 28 days or until hospital discharge, in addition to standard of care
Standard of Care	Active comparator	Other: Standard of CareStandard of care treatments for COVID-19 as determined appropriate by the Investigator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Confirmed infection with SARS-CoV-2 per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 7 days of randomization
Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen saturation <94% on room air or subject requires supplemental oxygen
Able to swallow capsules
Willing to follow contraception guidelines
Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board 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 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used

Key exclusion criteria (12 listed)

Known cardio-pulmonary resuscitation within 14 days prior to randomization
Pregnant or breast feeding
Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
Alanine aminotransferase (ALT) ≥ 3x upper limit of normal (ULN) and total bilirubin > 2x ULN
QTcF prolongation >480 milliseconds

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
AbivertinibAlso: abivertinib maleate, avitinib, AC0010, STI-5656Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.	Drug	Abivertinib with Standard of Care
Standard of CareStandard of Care as determined by the Investigator	Other	Abivertinib with Standard of Care, Standard of Care

Primary outcome

Percentage of Subjects Alive and Free of Respiratory Failure at Day 28
Time frame: Randomization to Day 28
Percentage of subjects alive and free of respiratory failure at Day 28, where respiratory failure, is defined based on resource utilization of any of the following modalities: * Noninvasive positive pressure ventilation or continuous positive airway pressure * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20L/min with fraction of delivered oxygen ≥ 0.5) * Extracorporeal membrane oxygenation

6 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events
Time frame: Randomization through study completion to 94 days
Percentage of Subjects Alive and Free of Respiratory Failure at Day 60
Time frame: Randomization to Day 60
Change in C-Reactive Protein (CRP)
Time frame: Day 7
Partial Pressure of Oxygen in Arterial Blood and Fraction of Inspired Oxygen (PaO2/FiO2)
Time frame: Day 1
All-cause Mortality at Day 60 and Day 90
Time frame: Day 60 and Day 90
Number of Days Alive Outside of Hospital up to Day 28
Time frame: Randomization up to Day 28

Results and safety

Results posted to the registry on 18 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abivertinib With Standard of Care	48	36
Placebo With Standard of Care	48	36

Primary outcome: Percentage of Subjects Alive and Free of Respiratory Failure at Day 28

Time frame: Randomization to Day 28. Count of participants. Unit: Participants

Measure	Abivertinib With Standard of Care n = 48	Placebo With Standard of Care n = 48
Value	40	38

Population analysed: A total of 48 subjects in the STI-5656 group and 48 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing of informed consent until end-of-trial visit, up to 94 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abivertinib With Standard of Care	9 of 48 (18.8%)	31 of 48 (64.6%)	8 of 48
Placebo With Standard of Care	8 of 46 (17.4%)	24 of 46 (52.2%)	5 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 JD study director

Sorrento Therapeutics, Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abivertinib in people with Covid-19, run by Sorrento Therapeutics, Inc. at 6 sites in United States.

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 5 inclusion and 12 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 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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. 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?

Yes. Results are posted in the registry (first posted 18 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects Alive and Free of Respiratory Failure at Day 28 (time frame: Randomization to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04440007.

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 18 Jan 2023.