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Acute Respiratory Distress Syndrome (ARDS)Phase 2NCT06703073

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)

A Phase 2 study testing Cohort A: vilobelimab, Cohort B: paridiprubart and Cohort C: bevacizumab in people with Acute Respiratory Distress Syndrome (ARDS) and ARDS, run by PPD Development, LP at 41 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cohort A: vilobelimab, Cohort B: paridiprubart and Cohort C: bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
41 sitesUnited States
Study dates
10 Jun 2025to Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each participant must meet all of the following criteria to be enrolled in this study:
  • Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements
  • Participant is at least 18 years of age or older at the time of consent.
  • Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS.
  • Note that participants on noninvasive ventilation may be screened.
  • Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply
  • Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90).

Who cannot join

  • Participants will be excluded from the study if any of the following apply:
  • Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.
  • Participant with pulmonary edema due to cardiogenic pulmonary edema/fluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.
  • Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions.
  • Participant is known to be pregnant, nursing, or with a positive (urine and/or serum test) pregnancy test.
  • Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.
Show all 24Show fewer
  • Participant is not expected to survive for 72 hours.
  • Participant has been on invasive mechanical ventilation or ECMO for ARDS for more than 48 hours for ARDS at the time of consent.
  • Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation
  • Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing.
  • Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.
  • Participant has NY Heart Association Class IV congestive heart failure.
  • Participant has a known allergy to any study medication or any of its excipients.
  • Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication therapy OR systemic immunosuppressive corticosteroids (prednisone ≥20 mg daily or equivalent). NOTE: Patients onreceiving chronic low dose immunosuppressive therapy may be enrolled(e.g., prednisone <20 mg/day or equivalent) and patients on stable, long-term maintenance immunosuppression (e.g., tacrolimus, mycophenolate, orsirolimus) and patients receiving physiologic replacement and hormonal therapies for breast cancer (e.g., tamoxifen, letrozole) or prostate cancer (leuprolide, bicalutamide) for >60 days may be eligible at the investigator's discretion of the investigator in consultation with the medical monitor.
  • Participant is receiving ongoing cytotoxic chemotherapy (IV or oral), OR combination targeted/immunotherapy regimens for cancer within the past 60 days. Note: Participants receiving non-myelosuppressive cancer therapy (e.g., hormonal therapy or selected targeted / immunotherapy regimens) may be eligible if therapy has been stable ≥60 days; The use of hydroxyurea to manage patients with chronic myeloid leukemia, polycythemia vera, essential thrombocythemia or sickle cell disease is permitted.
  • Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.
  • Participant with concurrent infections or history of the following:
  • Known active tuberculosis,
  • Known active Hepatitis B, or
  • HIV and a CD4 count less than 50 or a detectable viral load of >200 copies/mL HIV RNA.
  • Participant received treatment with any other investigational drugs within 30 days prior to consent.
  • Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening.
  • Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant may have additional cohort-specific requirements.

Trial locations and contacts

41 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Just Breathe Trial Team contact

Please email

crgjustbreathealerts.sm@thermofisher.com

41 sites in 1 country

United States41 sites, 40 recruiting

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109-5000

    Recruiting

  • University of Alabama Hospital

    Birmingham, Alabama, 35233-1932

    Not yet recruiting

  • St. Luke's Boise Medical Center

    Boise, Idaho, 83712-6241

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Not yet recruiting

  • Nova Clinical Research

    Bradenton, Florida, 34209-4617

    Recruiting

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805-0001

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-0001

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425-8908

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908-0816

    Not yet recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106-1716

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Not yet recruiting

  • Denver Health Hospital and Authority

    Denver, Colorado, 80204-4532

    Not yet recruiting

  • Henry Ford Health Hospital

    Detroit, Michigan, 48202-2608

    Recruiting

  • Durham VA Medical Center

    Durham, North Carolina, 27705-3875

    Recruiting

  • Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS

    Durham, North Carolina, 27710-4000

    Not yet recruiting

  • Northshore University Healthsystem Research Institute

    Evanston, Illinois, 60201-1700

    Not yet recruiting

  • Baylor All Saints Medical Center

    Fort Worth, Texas, 76104-4110

    Recruiting

  • Community Regional Medical Center

    Fresno, California, 93721-1324

    Recruiting

  • North Florida / South Georgia Veterans Health System

    Gainesville, Florida, 32608-1135

    Recruiting

  • Baylor St Luke's Medical Center

    Houston, Texas, 77030-4202

    Not yet recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Not yet recruiting

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806-1701

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107-5701

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-0004

    Recruiting

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901-1928

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065-6007

    Not yet recruiting

  • Weill Cornell Medical College

    New York, New York, 10065-8722

    Not yet recruiting

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104-3609

    Recruiting

  • University of California Irvine Medical Center

    Orange, California, 92868-3201

    Recruiting

  • OSF Saint Francis Medical Center-

    Peoria, Illinois, 61637-0001

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239-3011

    Recruiting

  • Renown Institute for Heart & Vascular Health

    Reno, Nevada, 89502-1576

    Withdrawn

  • Mayo Clinic

    Rochester, Minnesota, 55905-0001

    Recruiting

  • University of California Davis Medical Center - Pulmonary Medicine

    Sacramento, California, 95816-4300

    Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

    Recruiting

  • Swedish Medical Center

    Seattle, Washington, 98122-4379

    Recruiting

  • Stanford Medical Center

    Stanford, California, 94305-2200

    Recruiting

  • Montefiore Hospital - Moses Campus

    The Bronx, New York, 10467

    Recruiting

  • Mercy Health - St. Vincent Medical Center

    Toledo, Ohio, 43608-2603

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595-1530

    Not yet recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010-3017

    Recruiting

Other trials in United States

About this study

Official title: Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.

This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.

Read the detailed description

This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks).

Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival).

All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning.

For information specific to each intervention included in this platform trial, please refer to the below corresponding, separate, clinicaltrials.gov records:

Vilobelimab NCT06701682 ; Paridiprubart NCT06701669 ; Bevacizumab NCT06701656

Being tested
Cohort A: vilobelimab, Cohort A: placebo, Cohort B: paridiprubart, Cohort B: placebo, Cohort C: bevacizumab
Keywords
BARDA, JUST BREATHE, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
Medical subject headings
Respiratory Distress Syndrome, Acute Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort A: vilobelimabDrug

    Administered as an IV formulation of 800 mg per dose and up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)

  • Cohort A: placeboDrug

    Administered as an IV formulation of placebo of up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)

  • Cohort B: paridiprubartDrug

    Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1

  • Cohort B: placeboDrug

    Administered as a single IV dose of placebo on Day 1

  • Cohort C: bevacizumabDrug

    Administered as a single IV dose of 500 mg on Day 1

  • Cohort C: placeboDrug

    Administered as a single IV dose of placebo on Day 1

Study groups in NCT06703073
Study groupRoleWhat they receive
Cohort A: vilobelimabExperimentalNot described
Receives: Drug: Cohort A: vilobelimab
Cohort A: placeboPlacebo comparatorNot described
Receives: Drug: Cohort A: placebo
Cohort B: paridiprubartExperimentalNot described
Receives: Drug: Cohort B: paridiprubart
Cohort B: placeboPlacebo comparatorNot described
Receives: Drug: Cohort B: placebo
Cohort C: bevacizumabExperimentalNot described
Receives: Drug: Cohort C: bevacizumab
Cohort C: placeboPlacebo comparatorNot described
Receives: Drug: Cohort C: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality (ACM) rate at Day 28

    Measured: Day 28

Secondary outcomes (19)

  1. ACM at Day 60 and Day 90

    Measured: Day 60 and Day 90

  2. ACM+ at Day 28, Day 60, and Day 90

    Note: ACM+ composite score will be constructed by combining ACM and participant-relevant, infection-related Adverse Events (AE) and Serious Adverse Events (SAEs) from the MedDRA toxic/septic shock standardized MedDRA queries (SMQ).

    Measured: Day 28, Day 60, and Day 90

  3. Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)

    Measured: Up to and including Day 28 or until Discharge (whichever is earlier)

  4. Incidence of new invasive mechanical ventilation use during the study up to and including Day 28

    Measured: Up to and including Day 28

  5. Ventilator-free days up to and including Day 28

    Measured: Up to and including Day 28

  6. Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90

    Measured: Days 28, 60, and 90

  7. Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent

    Measured: Up to and including Day 28

  8. Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28

    Measured: up to and including Day 28

  9. Incidence of participants with new ECMO use during the study up to and including Day 28.

    Measured: up to and including Day 28

  10. Proportion of participants alive and free of ECMO at Days 28, 60, and 90

    Measured: Days 28, 60, and 90.

  11. Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8)

    Measured: While Hospitalized (up to 90 days)

  12. Time to an improvement of one category and two categories from baseline using the WHO 8-levels ordinal scale (from 0-8) at Days 28, 60, and 90 (while hospitalized)

    Measured: While Hospitalized (up to 90 days)

  13. Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)

    Measured: While Hospitalized (up to 90 days)

  14. Proportion of participants who improve clinical status as measured by the Karnofsky scale

    The Karnofsky scale is used to assess the general condition of the patient. Scores range from 0 to 100 with higher scores indicating better functional ability.

    Measured: Post hospitalization through Day 90

  15. Days of hospitalization up to and including Day 28

    Measured: up to and including Day 28

  16. Days of ICU stay up to and including Day 28

    Measured: up to and including Day 28

  17. Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90

    The SF-12 is a self-reported outcome measure composed by 12 items which examine eight dimensions of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

    Measured: From hospital discharge to Day 60 and to Day 90

  18. Change in St. George's Respiratory Questionnaire (SGRQ) from hospital discharge to Day 60 and to Day 90

    The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores range between 0 and 100 with higher scores indicating more limitations.

    Measured: From hospital discharge to Day 60 and to Day 90

  19. Incidence and severity of adverse events (AEs) /adverse event of special interest (AESI) / serious adverse event (SAEs)

    Measured: Through Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start10 Jun 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06703073
Sponsor's protocol ID
BP-ARDS-P2-001 (Master Record)
Other IDs
75A50124C00001
Status last verified
Jun 2026
First submitted
20 Nov 2024
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Truwit JD, Fleming K, Nanchal RS. Empowering Respiratory Therapists to Restrict Nebulized 3% Saline and N-Acetylcysteine During Mechanical Ventilation. Respir Care. 2025 Aug;70(8):937-945. doi: 10.1089/respcare.12586. Epub 2025 Feb 24.

    PubMed 40028879

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cohort A: vilobelimab, Cohort B: paridiprubart and Cohort C: bevacizumab in people with Acute Respiratory Distress Syndrome (ARDS) and ARDS, run by PPD Development, LP at 41 sites 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 7 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Just Breathe Trial Team (Please email, crgjustbreathealerts.sm@thermofisher.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (ACM) rate at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06703073, which also lists 1 linked publication.

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 31 Jul 2026.

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