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

NCT05083117 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-08-21

No results posted yet for this study

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.

Conditions

  • COVID-19 Acute Respiratory Distress Syndrome

Interventions

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.

Sponsors & Collaborators

  • Sciwind Biosciences USA Co., Ltd.

    collaborator INDUSTRY

  • Hangzhou Sciwind Biosciences Co., Ltd.

    collaborator INDUSTRY

  • Sciwind Biosciences APAC CO Pty. Ltd.

    lead INDUSTRY

Principal Investigators

  • Eddie Angles · Hospital Nacional Arzobispo Loayza

  • Ricardo Teijeiro · Hospital Pirovano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-30
Primary Completion
2022-03-10
Completion
2022-04-10

Countries

  • Argentina
  • Peru

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083117 on ClinicalTrials.gov