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JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

* ARDS Severity of mild, moderate or severe, based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization.

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

* Participant has a known allergy or hypersensitivity to the active substance/excipients, or Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies
* Participant with established cirrhosis and a modified Child-Pugh Score of 7 or greater
* Participant was dialysis-dependent prior to hospitalization. Participant must have a urine dipstick for proteinuria \< 2+
* The hospitalized participant has a history or currently experiencing the following:

  1. Participant must not have an international normalized ratio (INR) \>1.5 and/or aPTT \>1.5 × upper limit of normal (ULN) within 7 days prior to initiation of study treatment for participants not receiving anticoagulation. For participants on full dose oral or parenteral anticoagulants for therapeutic purposes the INR and/or activated partial thromboplastin time (aPTT) must be within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment.
  2. Participant with recent serious hemorrhage or history of recent hemoptysis \> 2 episodes (defined as ≥2.5 mL of bright red blood per episode) within 1 month of screening.
  3. Participant with inadequately controlled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg). Antihypertensive therapy is permitted to achieve these parameters.
  4. Participant with a history of hypertensive crisis or hypertensive encephalopathy.
  5. Participant with a history of Grade ≥ 4 venous thromboembolisms.
  6. Participant with significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 3 months of study drug treatment.
  7. Participant with history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months of study drug treatment.
  8. Participant with serious, non-healing wound, active ulcer, or untreated bone fracture.
  9. Participant with history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation).
  10. Participant with clinically significant cardiovascular disease including cerebrovascular accident or myocardial infarction within previous 6 months, unstable angina, congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication.
  11. Participant with a platelet count of \<75×109/L.
  12. Participant with current or recent (\<10 days prior to initiation of study treatment) use of aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day).
  13. Participant is receiving a direct anticoagulant (DOAC) such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) without the availability of a reversal agent at the site.
  14. Participant is receiving a DOAC such as betrixaban (Bevyxxa®) and edoxaban (Lixiana®) for which there is no approved reversal agent.
  15. Participant has urine dipstick for proteinuria ≥ 2+

About the study

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.

Cohort C: Participants will be randomized to receive either a placebo or bevacizumab.

This record describes the default procedures and analyses for Cohort C. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

What is being tested

Sponsor: PPD Development, LP · Participants: 200 · Started: Oct 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06701656

Locations in the U.S.

AlabamaUniversity of Alabama Hospital, Birmingham (Not yet recruiting)
CaliforniaCommunity Regional Medical Center, Fresno
Long Beach Memorial Medical Center, Long Beach
University of California Irvine Medical Center, Orange
University of California Davis Medical Center - Pulmonary Medicine, Sacramento
Stanford Medical Center, Stanford
ColoradoDenver Health Hospital and Authority, Denver
District of ColumbiaMedStar Washington Hospital Center, Washington D.C.
FloridaNova Clinical Research, Bradenton
North Florida / South Georgia Veterans Health System, Gainesville
Sarasota Memorial Hospital, Sarasota
IdahoSt. Luke's Boise Medical Center, Boise
IllinoisNorthshore University Healthsystem Research Institute, Evanston (Not yet recruiting)
OSF Saint Francis Medical Center-, Peoria
MassachusettsTufts Medical Center, Boston (Not yet recruiting)
Lahey Hospital and Medical Center, Burlington
MichiganUniversity of Michigan Hospital, Ann Arbor
Henry Ford Health Hospital, Detroit
MinnesotaMayo Clinic, Rochester
New JerseyRobert Wood Johnson Medical School, New Brunswick
New YorkMemorial Sloan Kettering Cancer Center, New York (Not yet recruiting)
Weill Cornell Medical College, New York (Not yet recruiting)
Montefiore Hospital - Moses Campus, The Bronx
Westchester Medical Center, Valhalla (Not yet recruiting)
North CarolinaUniversity of North Carolina at Chapel Hill, Chapel Hill
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS, Durham (Not yet recruiting)
Durham VA Medical Center, Durham
OhioCleveland Clinic, Cleveland (Not yet recruiting)
University Hospitals Cleveland Medical Center, Cleveland (Not yet recruiting)
Mercy Health - St. Vincent Medical Center, Toledo
OklahomaThe University of Oklahoma Health Sciences Center, Oklahoma City
OregonOregon Health and Science University, Portland
South CarolinaMedical University of South Carolina (MUSC), Charleston
TennesseeVanderbilt University Medical Center, Nashville
TexasBaylor All Saints Medical Center, Fort Worth
Baylor St Luke's Medical Center, Houston (Not yet recruiting)
Houston Methodist Hospital, Houston (Not yet recruiting)
UtahIntermountain Medical Center, Murray
VirginiaUniversity of Virginia Health System, Charlottesville (Not yet recruiting)
WashingtonSwedish Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.