COVID-19 Acute Respiratory Distress SyndromePhase 2NCT05083117
Safety and Efficacy of Inhaled XW001 For Hospitalized COVID-19 Patients Requiring Oxygen Therapy
A Phase 2 study testing XW001 in people with COVID-19 Acute Respiratory Distress Syndrome, run by Sciwind Biosciences APAC CO Pty. Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- XW001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Oct 2021to 10 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
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.
Read the 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.
- Being tested
- XW001, Placebo
- Keywords
- Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XW001Drug
Also called IL-29 analog
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 35 days
Change from the baseline in clinical laboratory results
Percentage of the lab results change
Measured: 35 days
Incidence of clinically significant laboratory findings
Percentage of the lab results change
Measured: 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.
Measured: 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.
Measured: 35 days
Secondary outcomes (12)
Time to clinical improvement from the time of randomization.
Time to clinical improvement is defined as the time (in days) from the randomization date to the first day on which a patient satisfies a score of 0, 1, 2, or 3 on the 9-point WHO-OSCI and maintains a score ≤3 at least 48 hours (initial improvement) and maintains this up to the 28-day timeframe (sustained improvement)
Measured: 28 days
Time to hospital discharge from the time of randomization
At or below WHO-OSCI score 2 from the time of randomization
Measured: 28 days
Time to clinical recovery from the time of randomization
Time of clinical recovery (in days) will be calculated using the WHO-OSCI from the randomization date to the first day on which the patient satisfies a score of 0 or 1 on the 9-point WHO-OSCI and remains at 0 or 1 until Day 28 (has no subsequent readmission for COVID-19 signs or symptoms)
Measured: 28 days
Time to viral clearance
targeted not detected on real-time quantitative polymerase chain reaction [qPCR] assay) from the time of randomization
Measured: 28 days
Viral load kinetics on real-time qPCR assay
A real-time qPCR will be done to determine the viral load kinetics in positive RT-PCR samples.
Measured: 28 days
Proportions of patients experiencing clinical improvement, hospital discharge, clinical recovery, and viral clearance
The proportions of patients will be compared using the logistic regression.
Measured: 28 days
Proportion of patients experiencing clinical progression from the time of randomization
The proportions of patients will be compared using the logistic regression.
Measured: 35 days
Proportion of patients progressing to on noninvasive ventilation or high-flow oxygen from the time of randomization
The proportions of patients will be compared using the logistic regression.
Measured: 35 days
Proportion of patients progressing to on intubation with ventilation from the time of randomization
The proportions of patients will be compared using the logistic regression.
Measured: 35 days
Proportion of patients progressing to death from the time of randomization
Proportion of patients progressing to death (WHO-OSCI score 8) within the 35-day timeframe from the time of randomization
Measured: 35 days
Changes from the baseline in the BCSS total score and breathlessness and cough subscores
Change from the baseline in the BCSS scores will also be evaluated daily. A physical examination including height and weight will be measured. Height will be measured at screening only. If a patient is not able to stand easily, the patient may provide height.
Measured: 35 days
Changes from the baseline in the NEWS2
Change from the baseline in the NEWS2 scores will also be evaluated daily. A physical examination including height and weight will be measured. Height will be measured at screening only. If a patient is not able to stand easily, the patient may provide height.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start30 Oct 2021 (estimated)
- Primary completion10 Mar 2022 (estimated)
- Study completion10 Apr 2022 (estimated)
Why it stopped: Difficulty in COVID-19 subject enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciwind Biosciences APAC CO Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sciwind Biosciences USA Co., Ltd., Hangzhou Sciwind Biosciences Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Eddie Angles, Principal investigator, Hospital Nacional Arzobispo LoayzaRicardo Teijeiro, Principal investigator, Hospital Pirovano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083117
- Sponsor's protocol ID
- SCW1201-3121
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05083117
- Acronym / sponsor ID
- SCW1201-3121
- Keywords
- Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in COVID-19 subject enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sciwind Biosciences APAC CO Pty. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sciwind Biosciences USA Co., Ltd., Hangzhou Sciwind Biosciences Co., Ltd.
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 10 Mar 2022 (estimated)
- Study completion
- 10 Apr 2022 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XW001 | Experimental | Drug: XW001Treatment 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XW001Also: IL-29 analogIt 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 | XW001 |
| PlaceboIt 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. | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 35 days
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
Change from the baseline in clinical laboratory results
Time frame: 35 days
Percentage of the lab results change
Incidence of clinically significant laboratory findings
Time frame: 35 days
Percentage of the lab results change
Change from the baseline in vital signs results
Time frame: 35 days
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.
Change from the baseline in electrocardiogram (ECG) findings
Time frame: 35 days
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.
12 secondary outcomes
Time to clinical improvement from the time of randomization.
Time frame: 28 days
Time to hospital discharge from the time of randomization
Time frame: 28 days
Time to clinical recovery from the time of randomization
Time frame: 28 days
Time to viral clearance
Time frame: 28 days
Viral load kinetics on real-time qPCR assay
Time frame: 28 days
Proportions of patients experiencing clinical improvement, hospital discharge, clinical recovery, and viral clearance
Time frame: 28 days
Proportion of patients experiencing clinical progression from the time of randomization
Time frame: 35 days
Proportion of patients progressing to on noninvasive ventilation or high-flow oxygen from the time of randomization
Time frame: 35 days
Proportion of patients progressing to on intubation with ventilation from the time of randomization
Time frame: 35 days
Proportion of patients progressing to death from the time of randomization
Time frame: 35 days
Changes from the baseline in the BCSS total score and breathlessness and cough subscores
Time frame: 35 days
Changes from the baseline in the NEWS2
Time frame: 35 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddie Angles principal investigator
Hospital Nacional Arzobispo Loayza
Ricardo Teijeiro principal investigator
Hospital Pirovano
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XW001 in people with COVID-19 Acute Respiratory Distress Syndrome, run by Sciwind Biosciences APAC CO Pty. Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: 35 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.