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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Aptabio Therapeutics, Inc. · Individual
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2021-05-10
• Last updated: 2024-01-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study