A Phase 2 Study of APX-115 in Hospitalized Patients With Confirmed Mild to Moderate COVID-19.

Study Purpose

This phase 2 study is to assess the safety and tolerability of APX-115 active doses compared to placebo following multiple oral dosing in hospitalized patients with confirmed, mild to moderate, symptomatic COVID-19. It is anticipated that approximately 80 patients will be randomized into the study in a 1:1 ratio to 100 mg APX-115 or placebo arm.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Willing and able to provide informed consent themselves or through their legally authorized representative. 2. 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. 3. 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 . 4. Onset of COVID-19 symptoms within 14 days prior to randomization. 5. Have at least one of the following symptoms at screening: fever, cough, shortness of breath, myalgia, ageusia, anosmia, fatigue, or weakness. 6. 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]) 7. 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:

1. Females who are pregnant (negative pregnancy test required for all women of childbearing potential at screening) or breastfeeding. 2. 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. 3. 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).
4. Expected survival less than 72 hours. 5. 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. 6. 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. 7. History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator. 8. Use of any other concurrent investigational drugs while participating in the present study. 9. 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). 10. Known renal disease with an estimated glomerular filtration rate <30 mL/min. 11. 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. 12. 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. 13. Total bilirubin >1.5 × ULN, unless the patient has known Gilbert's syndrome. 14. Hemoglobin <9 g/dL for females or <11 g/dL for males. 15. Absolute neutrophil count <1500/mm3. 16. Thrombocytopenia (platelets count <100 × 109/L). 17. Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (eg, Crohn's disease) or malabsorption at screening. 18. 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. 19. History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04880109
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Aptabio Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

COVID-19
Additional Details

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.

Arms & Interventions

Arms

Experimental: APX-115

Oral administration of APX-115 100mg, daily for 14 days

Placebo Comparator: Placebo

Oral administration of Placebo, daily for 14 days

Interventions

Drug: - APX-115

Oral administration of APX-115 100 mg capsule once daily for 14 days

Drug: - Placebo

Oral administration of placebo capsule once daily for 14 days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Alternative Research Associates, LLC, Hialeah, Florida

Status

Not yet recruiting

Address

Alternative Research Associates, LLC

Hialeah, Florida, 33012

Site Contact

Luis Mendez Mulet, Dr.

hyesung.shin@aptabio.com

+82313653693

Anne Arundel Medical Center, Baltimore, Maryland

Status

Recruiting

Address

Anne Arundel Medical Center

Baltimore, Maryland, 21401

Site Contact

Barry Meisenberg, Dr.

hyesung.shin@aptabio.com

+82313653693

Millennium Physicians Group, Houston, Texas

Status

Not yet recruiting

Address

Millennium Physicians Group

Houston, Texas, 77070

Site Contact

Mohsin Bajwa, Dr.

hyesung.shin@aptabio.com

+82313653693

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.