- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880109
A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.
A Phase 2, Double-blind, Placebo-controlled, Efficacy, and Safety Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.
Study Overview
Detailed Description
APX-115 is a potent small molecule inhibitor of NADPH-oxidase (Nox) isozymes being developed by Aptabio Therapeutics Inc. The Nox enzymes represent a family of 7 membrane enzymes (Nox1, Nox2, Nox3, Nox4, Nox5, Duox1, and Duox2) which catalyze NADPH-dependent generation of superoxide and secondary reactive oxygen species (ROS).
ROS are often generated during virus infection, thus promoting apoptosis, lung injury, and inflammation/allergy.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hyesung Shin
- Phone Number: +82313653693
- Email: hyesung.shin@aptabio.com
Study Locations
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Florida
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Hialeah, Florida, United States, 33012
- Alternative Research Associates, LLC
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Maryland
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Baltimore, Maryland, United States, 21401
- Anne Arundel Medical Center
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Texas
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Houston, Texas, United States, 77070
- Millennium Physicians Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willing and able to provide informed consent themselves or through their legally authorized representative.
- Male or female patients, of any race or ethnicity, 18 to 80 years of age, inclusive, on the day of informed consent. Racial and ethnic minorities should be included in the study population to the greatest extent possible.
- Laboratory-confirmed SARS-CoV-2 infection as determined within 14 days of randomization by real time RT-PCR or other commercial or public health assay authorized by FDA or other applicable health authority .
- Onset of COVID-19 symptoms within 14 days prior to randomization.
- Have at least one of the following symptoms at screening: fever, cough, shortness of breath, myalgia, ageusia, anosmia, fatigue, or weakness.
- Hospitalized with COVID-19 disease (WHO COVID-19 Clinical Improvement Ordinal Scale score of 3 [hospitalized, no oxygen therapy], 4 [hospitalized, oxygen by mask or nasal prongs], or 5 [high-flow oxygen or non-invasive mechanical ventilation])
- Patient is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the informed consent form.
Exclusion Criteria:
- Females who are pregnant (negative pregnancy test required for all women of childbearing potential at screening) or breastfeeding.
- Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as postmenopausal for >12 months) who are not using at least one protocol specified method of contraception.
- COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation).
- Expected survival less than 72 hours.
- Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection within 7 days or within 5 half-lives, whichever is longer, prior to enrollment or concurrently. Drugs that have received FDA emergency use authorization or COVID-19 approval are allowed.
- Treatment with immunosuppressants, combination of 2 or more RAS blockers, UGT inhibitors and inducers, herbal/natural supplements, potassium-sparing diuretic, and radiographic contrast agent prior to enrollment or concurrently.
- History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator.
- Use of any other concurrent investigational drugs while participating in the present study.
- Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (eg, for organ transplantation or autoimmune conditions).
- Known renal disease with an estimated glomerular filtration rate <30 mL/min.
- Patients with clinically apparent liver disease (eg, jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis) or moderate or severe hepatic impairment as determined by Child-Pugh score Class B or C.
- Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) >3 × upper limit of normal (ULN) AND total bilirubin levels >2 × ULN OR ALT or AST >5 × ULN.
- Total bilirubin >1.5 × ULN, unless the patient has known Gilbert's syndrome.
- Hemoglobin <9 g/dL for females or <11 g/dL for males.
- Absolute neutrophil count <1500/mm3.
- Thrombocytopenia (platelets count <100 × 109/L).
- Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (eg, Crohn's disease) or malabsorption at screening.
- Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.
- History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APX-115
Oral administration of APX-115 100mg, daily for 14 days
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Oral administration of APX-115 100 mg capsule once daily for 14 days
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Placebo Comparator: Placebo
Oral administration of Placebo, daily for 14 days
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Oral administration of placebo capsule once daily for 14 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Time Frame: over the 60-day period
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Adverse events will be assessed to evaluate the safety and tolerability of APX-115 in mild-to-moderate COVID-19 patients.
Clinical laboratory evaluations, vital signs, and ECG will be used to assess adverse events.
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over the 60-day period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to clinical recovery
Time Frame: Up to 60 Days
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Recovery is defined as when WHO Clinical Improvement Ordinal Scale equal to or less than 3
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Up to 60 Days
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Time to discharge
Time Frame: Up to Day 60
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WHO Clinical Improvement Ordinal Scale is equal to or less than 2
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Up to Day 60
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Time to symptomatic recovery
Time Frame: Up to Day 60
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When none of the COVID-19 Symptom Assessment scores are higher than 1
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Up to Day 60
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Time to complete symptomatic recovery
Time Frame: Up to Day 60
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When none of the COVID-19 Symptom Assessment scores are higher than 0
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Up to Day 60
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Change in log10 SARS-CoV-2 viral load
Time Frame: Up to Day 14
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hange from baseline in log10 SARS-CoV-2 viral load as measured by RT-PCR by Days 5 and 14
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Up to Day 14
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Proportion of patients in clinical recovery
Time Frame: Up to Day 29
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Symptom Assessment
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Up to Day 29
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scoring of WHO Clinical Improvement Ordinal Scale
Time Frame: Up to Day 29
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9-point scale on key analysis days for levels ≥3
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Up to Day 29
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Changes from baseline in anti-inflammatory markers in blood
Time Frame: Day 1 and Day 14
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Blood will be analyzed for changes from baseline in anti-inflammatory markers, such as C-reactive protein, ferritin, lactate dehydrogenase, D-dimer, troponin, and transforming growth factor-β.
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Day 1 and Day 14
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Changes from baseline in pro-inflammatory cytokines in blood
Time Frame: Day 1 and 14
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Blood will be analyzed for changes from baseline in pro-cytokine panel of the blood, such as interleukin (IL)-1β, IL-6, and interferon-γ.
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Day 1 and 14
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Changes from baseline in 8-isoprostane in blood
Time Frame: Days 1 and 14
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Blood will be analyzed for changes from baseline in 8-isoprostane.
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Days 1 and 14
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Trough (predose) plasma concentration (Ctrough)
Time Frame: Day 1
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Trough (predose) plasma concentration (Ctrough) will be analyzed from plasma samples for pharmacokinetic assessment of APX-115.
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Day 1
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Maximum observed plasma concentration (Cmax)
Time Frame: Days 1, 5, and 14
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Maximum observed plasma concentration (Cmax) will be analyzed from plasma samples for pharmacokinetic assessment of APX-115.
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Days 1, 5, and 14
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Time to Cmax (Tmax)
Time Frame: Days 1, 5, and 14
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Time to Cmax (Tmax) will be analyzed from plasma samples for pharmacokinetic assessment of APX-115.
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Days 1, 5, and 14
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Area under the plasma concentration versus time curve (AUC) from time zero to the Time of last quantifiable concentration (AUC0-last)
Time Frame: Days 1, 5, and 14
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Area under the plasma concentration versus time curve (AUC) from time zero to the time of last quantifiable concentration (AUC0-last) will be analyzed from plasma samples for pharmacokinetic assessment of APX-115.
|
Days 1, 5, and 14
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AUC within a dosing interval (AUCtau, where tau = 12 hours)
Time Frame: Days 1, 5, and 14
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AUC within a dosing interval (AUCtau, where tau = 12 hours) will be analyzed from plasma samples for pharmacokinetic assessment of APX-115.
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Days 1, 5, and 14
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A01-115-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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