Acute Lung InjuryPhase 1ALINCT04526912
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
A Phase 1 study testing VIB7734 in people with Acute Lung Injury, run by Viela Bio at 1 site in United States.
Trial summary
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- VIB7734
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 19 May 2021
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with coronavirus disease 2019 (COVID-19) pneumonia confirmed by World Health Organization criteria.
- Oxygen saturation ≤ 94% at room air or arterial partial pressure of oxygen/fraction of inspired oxygen < 300 mm Hg and > 200 mm Hg.
- Negative influenza test.
- Lymphocyte counts < 10^3/μL and the presence of at least one of the following markers of hyperinflammation within 1 day prior to VIB7734 administration:
- Elevated high sensitivity C-reactive protein (hsCRP) > 50 mg/L
- Ferritin > 500 ng/mL
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- Lactate dehydrogenase (LDH) > 300 U/L
- D-dimers > 500 ng/mL
- NOTE: Other protocol defined inclusion criteria apply
Who cannot join
- Respiratory failure requiring mechanical ventilation.
- In the opinion of the Investigator, progression to mechanical ventilation or death is imminent and inevitable within the next 24 hours.
- Valid Do Not Intubate (DNI) or Do Not Resuscitate (DNR) order.
- Anticipated duration of hospital stay < 72 hours.
- History of allergy or hypersensitivity reaction to any component of the IP.
- Participation in another clinical study with an IP within 4 weeks prior to Day 1 or within 5 half-lives of the IP, whichever is longer. (Participation in COVID-19 antiviral or antimalarial trials may be permitted after discussion with the Medical Monitor).
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- Liver cirrhosis or liver failure.
- Known human immunodeficiency virus infection.
- Known hepatitis B or known hepatitis C infection in the absence of a history of curative therapy.
- Known or suspect active or latent tuberculosis infection.
- Active bacterial, fungal, viral, or other infection (besides COVID-19).
- Clinically significant cardiac disease within 6 months.
- History of severely impaired respiratory function at baseline (not related to COVID-19) based on requirement for home oxygen of > 4 L/min or based on other medical history known to the Investigator.
- History of cancer within 12 months of enrollment.
- Receipt of chemotherapy, biologic immunomodulators (including JAK inhibitors), or immunosuppressive therapies within 8 weeks of enrollment, or receipt of rituximab or other B cell-depleting mAb therapy within 6 months.
- NOTE: Other protocol defined exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study intended to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Efficacy will be assessed during the 28 days following a single administration of VIB7734. Safety will be assessed for 10 weeks following dosing. The pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of VIB7734 in patients with confirmed SARS-CoV-2 infections will also be assessed.
- Conditions
- Acute Lung Injury
- Being tested
- VIB7734, Placebo
- Keywords
- pneumonia, COVID-19, SARS-Cov-2, acute respiratory disease
- Medical subject headings
- Acute Lung Injury, Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIB7734Drug
Single subcutaneous dose
PlaceboDrug
Intravenous single dose matched to VIB7734.
| Study group | Role | What they receive |
|---|---|---|
| VIB7734 Dose | Experimental | Participants will receive a single subcutaneous dose of VIB7734. Receives: Drug: VIB7734 |
| Placebo | Placebo comparator | Participants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness
Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg, or requiring vasopressors)
Measured: Day 1 (Baseline) through Day 28
Secondary outcomes (2)
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events
Defined as measure of safety
Measured: Day 1 (Baseline) through Day 70
Change in safety laboratory parameters
Safety evaluation via review of labs (white blood cell (WBC) with differential counts, hemoglobin, platelet count, liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin levels), serum chemistry, cardiac troponin coagulation markers (prothrombin time [PT], partial thromboplastin time [PTT], D dimer, fibrinogen), and urinalysis)
Measured: Day 1 (Baseline) through Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start28 Aug 2020
- Primary completion8 Apr 2021
- Study completion19 May 2021
Why it stopped: Study met predefined futility criteria for efficacy endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viela Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gábor Illei, MD, PhD, MHS, Study director, Vice President, Clinical Development Lead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526912
- Sponsor's protocol ID
- VIB7734.P1.S2
- Acronym
- ALI
- Status last verified
- Dec 2021
- First submitted
- 21 Aug 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study of the Safety and Efficacy of VIB7734 for the Treatment and Prevention of Acute Lung Injury (ALI) in Patients With SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04526912
- Acronym / sponsor ID
- ALI / VIB7734.P1.S2
- Conditions
- Acute Lung Injury
- Keywords
- pneumonia, COVID-19, SARS-Cov-2, acute respiratory disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study met predefined futility criteria for efficacy endpoints.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Viela BioIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 26 Aug 2020 (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.
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Subjects will be administered a single dose of VIB7734 injected under the skin, assessed for efficacy for 28 days and followed for an additional 42 days.
Detailed description
This is a randomized, double-blind, placebo-controlled study intended to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) with pulmonary involvement. Efficacy will be assessed during the 28 days following a single administration of VIB7734. Safety will be assessed for 10 weeks following dosing. The pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of VIB7734 in patients with confirmed SARS-CoV-2 infections will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIB7734 Dose | Experimental | Drug: VIB7734Participants will receive a single subcutaneous dose of VIB7734. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single subcutaneous dose of placebo (saline) matched to single dose of VIB7734. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hospitalized with coronavirus disease 2019 (COVID-19) pneumonia confirmed by World Health Organization criteria.
- Oxygen saturation ≤ 94% at room air or arterial partial pressure of oxygen/fraction of inspired oxygen < 300 mm Hg and > 200 mm Hg.
- Negative influenza test.
- Lymphocyte counts < 10^3/μL and the presence of at least one of the following markers of hyperinflammation within 1 day prior to VIB7734 administration:
- NOTE: Other protocol defined inclusion criteria apply
Key exclusion criteria (16 listed)
- Respiratory failure requiring mechanical ventilation.
- In the opinion of the Investigator, progression to mechanical ventilation or death is imminent and inevitable within the next 24 hours.
- Valid Do Not Intubate (DNI) or Do Not Resuscitate (DNR) order.
- Anticipated duration of hospital stay < 72 hours.
- History of allergy or hypersensitivity reaction to any component of the IP.
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 |
|---|---|---|
| VIB7734Single subcutaneous dose | Drug | VIB7734 Dose |
| PlaceboIntravenous single dose matched to VIB7734. | Drug | Placebo |
Primary outcome
The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness
Time frame: Day 1 (Baseline) through Day 28
Critical illness is defined by respiratory failure (requiring any of the following: endotracheal intubation, oxygen delivered by high flow nasal cannula, non-invasive positive pressure ventilation, extracorporeal membrane oxygenation or clinical diagnosis of respiratory failure) or shock (systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg, or requiring vasopressors)
2 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent fatal and life-threatening SAEs, Treatment-emergent Serious Adverse Events
Time frame: Day 1 (Baseline) through Day 70
Change in safety laboratory parameters
Time frame: Day 1 (Baseline) through Day 70
Results and safety
The study was stopped early (reason given: Study met predefined futility criteria for efficacy endpoints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- 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.
Gábor Illei, MD, PhD, MHS study director
Vice President, Clinical Development Lead
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIB7734 in people with Acute Lung Injury, run by Viela Bio at 1 site in United States.
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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Study met predefined futility criteria for efficacy endpoints.). Results are not available in the source record.
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?
The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness (time frame: Day 1 (Baseline) through Day 28). 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 17 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.