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

NCT05083117 | Withdrawn Phase 2 DMC

• 1 other identifier: SCW1201-3121
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (5)

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events (TEAEs), grade ≥3 TEAEs, SAEs, TEAEs leading to premature discontinuation of study treatment, TEAEs leading to study discontinuation, and TEAEs leading to deaths

  35 days

• Change from the baseline in clinical laboratory results

  Percentage of the lab results change

  35 days

• Incidence of clinically significant laboratory findings

  Percentage of the lab results change

  35 days

• Change from the baseline in vital signs results

  Vital signs will be recorded twice daily while the patient is hospitalized. Vital signs may also be performed at other times if judged clinically appropriate or if the ongoing review of the data suggests a more detailed assessment of vital signs is required.

  35 days

• Change from the baseline in electrocardiogram (ECG) findings

  A 12-lead ECG is to be performed at screening in the supine position and at rest for at least 5 minutes. Additionally, a 12-lead ECG will be performed if QT abnormality is noted or early termination while the patient is hospitalized or at the discretion of the investigator.

  35 days

Secondary Outcomes (12)

• Time to clinical improvement from the time of randomization.

  28 days

• Time to hospital discharge from the time of randomization

  28 days

• Time to clinical recovery from the time of randomization

  28 days

• Time to viral clearance

  28 days

• Viral load kinetics on real-time qPCR assay

  28 days

Other Outcomes (2)

• Serum XW001 concentration and appropriate serum XW001

  35 days

• Proportions of patients with newly emerging serum anti-XW001 antibody

  35 days

Study Arms (2)

XW001

EXPERIMENTAL

Treatment arm patients will receive inhaled XW001 1 mg, once daily, using a commercially available nebulizer (Aerogen Solo, Aerogen Ireland) 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.

Drug: XW001

Placebo

PLACEBO COMPARATOR

Placebo arm patients will receive volume-matching placebo 1 mL, once daily, using a commercially available nebulizer (Aerogen Solo, Aerogen Ireland) 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.

Drug: Placebo

Interventions

XW001 DRUG

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.

Also known as: IL-29 analog

XW001

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or nonpregnant or nonlactating female, aged 18 to 70 years at the time of consenting
• Hospitalized due to infection with SARS-CoV-2 confirmed on validated local RT-PCR or other equivalent assays within 48 hours prior to screening and within 96 hours prior to randomization
• Assessed to be hospitalized cases (rated at WHO-OSCI score 4 \[on oxygen therapy by mask or nasal prongs\]) within 24 hours prior to randomization
• Admitted to hospital as clinically indicated for management of severe COVID-19 defined by the following criteria:
• Positive RT-PCR test for SARS-CoV-2 or an equivalent test
• Symptom suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
• Clinical signs indicative of severe illness with COVID-19, being given oxygenation and meeting one of the following:
• Respiratory rate ≥30 breaths per minute
• Heart rate ≥125 beats per minute
• Oxygen saturation (SpO2) \<94% on room air at sea level
• Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) \<300 mmHg or SpO2/FiO2 \<315 mmHg
• Lung infiltrates \>50%
• No criteria for critical severity
• Female of childbearing potential must be postmenopausal for 1 year or longer, surgically sterile or having used a medically effective method of contraception for at least 3 months prior to hospitalization
• Willing and able to provide a signed and dated or electronic informed consent for participation in this study.

You may not qualify if:

• Patients will be excluded from the study if they satisfy any of the following criteria at the screening visit unless otherwise stated:
• Having become symptomatic (fever, cough, and other likely symptoms) or positive on virologic test for more than 8 days prior to hospitalization
• Diagnosed with SARS-CoV-2 confirmed more than 48 hours prior to hospitalization, otherwise reconfirmed positive on repeated RT-PCR (local laboratory) or other equivalent assays within 48 hours prior to randomization
• Having been hospitalized for more than 48 hours, or showing a worsening medical condition within 48 hours after hospitalization in the opinion of the investigator
• Known to have received any approved or investigational COVID-19 vaccines within 6 months prior to randomization. Vaccination records can be self-reported by the patient if there is no recorded history
• Known to have received any approved or investigational therapeutic agents against SARS-CoV-2 including convalescent plasma, monoclonal antibodies, except for remdesivir, dexamethasone, or IL-6 inhibitors as a part of SoC
• Having received any investigational medicinal products within 90 days of randomization
• On noninvasive ventilation, eg, continuous positive airway pressure or bilevel positive airway pressure or high-flow oxygen therapy (at WHO-OSCI score 5)
• Intubated, ventilated (invasively), on any advanced organ/life support (pressors, renal replacement therapy, ECMO), or remaining in the intensive care unit (at WHO-OSCI score 6 and 7)
• Known to be hypersensitive or allergic to any natural or recombinant protein products
• Inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications
• Patients with cardiac disease (New York Heart Association III/IV), liver cirrhosis (\>5 x upper limit of normal \[ULN\]), on chemotherapy, dialysis patients with estimated glomerular filtration rate \<30 mL/min/1.73m2, or have other debilitating condition or any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or non- COVID-19 irreversible underlying condition with projected fatal course within 6 months or with high-risk of mortality
• Female patients are pregnant or lactating, or male or female patients have a childbearing plan within 30 days prior to randomization until 90 days after the last dosing.

Sponsors & Collaborators

• Sciwind Biosciences APAC CO Pty. Ltd.: lead
• Sciwind Biosciences USA Co., Ltd.: collaborator
• Hangzhou Sciwind Biosciences Co., Ltd.: collaborator

Study Sites (2)

Hospital Pirovano

CABA, Bs AS, 1430, Argentina

Location

Hospital Nacional Arzobispo Loayza

Lima, 511, Peru

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

XW001

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Eddie Angles

  Hospital Nacional Arzobispo Loayza

  PRINCIPAL INVESTIGATOR

• Ricardo Teijeiro

  Hospital Pirovano

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 19, 2021
• Study Start: October 30, 2021
• Primary Completion: March 10, 2022
• Study Completion: April 10, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1); AR (1)