NCT05083117

Safety and Efficacy of Inhaled XW001 For Hospitalized COVID-19 Patients Requiring Oxygen Therapy

Safety and Efficacy of Inhaled XW001 (Interleukin 29 Analog for Nebulization) For Hospitalized COVID-19 Patients Requiring Oxygen Therapy: A Multiregional, Randomized, Double-blind, Placebo-controlled Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multiregional, randomized, double-blind, placebo-controlled Phase 2 study in patients with confirmed symptomatic COVID-19, designed to evaluate the safety, tolerability, efficacy, and PK of XW001 (IL-29 analog) inhalation solution. The purpose of this study is to evaluate whether treatment with XW001 reduces the likelihood of worsening disease in patients with severe COVID-19. Hospitalized patients on oxygen therapy by mask or nasal prongs (WHO-OSCI score 4) will be enrolled.

Detailed description

Treatment arm patients will receive inhaled XW001 1 mg and placebo arm patients will receive volume-matching placebo 1 mL, once daily, using a commercially available nebulizer for up to 14 days. Treatment should be continued until discharge or progression to score 6 or higher but maximum up to 14 days. Dosing must be started within 48 hours of hospitalization. In addition, both the treatment groups will receive SoC. The present study is a pilot in the development phase and comprising approximately 120 patients. An independent, external Data Monitoring Committee (DMC) will review all the preliminary clinical data available, including safety, tolerability, efficacy, and PK for the first 20 patients. The decision to recruit the subsequent 100 patients will solely depend on safety and tolerability.

Conditions

• COVID-19 Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	XW001	It is anticipated that inhalation of 1 mg XW001 solution up to 14 days will result in a relatively lower systemic exposure in COVID-19 patients on oxygen therapy compared to that in healthy participants as COVID-19 patients tend to have impaired lung function of diffusive, restrictive, obstructive, or mixed origins.
DRUG	Placebo	It is anticipated that inhalation of 1 mg Placebo solution up to 14 days will result in a relatively lower systemic exposure in COVID-19 patients on oxygen therapy compared to that in healthy participants as COVID-19 patients tend to have impaired lung function of diffusive, restrictive, obstructive, or mixed origins.

Timeline

• Start date: 2021-10-30
• Primary completion: 2022-03-10
• Completion: 2022-04-10
• First posted: 2021-10-19
• Last updated: 2023-08-21

Locations

2 sites across 2 countries: Argentina, Peru