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

NCT04880109 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: A01-115-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

COVID-19

Keywords

Pulmonary fibrosis; COVID-19; SARS-COV-2; ROS

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  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.

  over the 60-day period

Secondary Outcomes (15)

• Time to clinical recovery

  Up to 60 Days

• Time to discharge

  Up to Day 60

• Time to symptomatic recovery

  Up to Day 60

• Time to complete symptomatic recovery

  Up to Day 60

• Change in log10 SARS-CoV-2 viral load

  Up to Day 14

Study Arms (2)

APX-115

EXPERIMENTAL

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

Drug: APX-115

Placebo

PLACEBO COMPARATOR

Oral administration of Placebo, daily for 14 days

Drug: Placebo

Interventions

APX-115 DRUG

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

APX-115

Placebo DRUG

Oral administration of placebo capsule once daily for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aptabio Therapeutics, Inc.: lead
• Covance: collaborator

Study Sites (3)

Alternative Research Associates, LLC

Hialeah, Florida, 33012, United States

Location

Anne Arundel Medical Center

Baltimore, Maryland, 21401, United States

Location

Millennium Physicians Group

Houston, Texas, 77070, United States

Location

MeSH Terms

Conditions

COVID-19; Pulmonary Fibrosis

Interventions

isuzinaxib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 10, 2021
• Study Start: October 20, 2021
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (3)