Cohort C: bevacizumab: Administered as a single IV dose of 500 mg on Day 1
Cohort C: placebo: Administered as a single IV dose of placebo on Day 1
Study 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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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+
Primary outcome measure(s)
All-cause mortality (ACM) rate at Day 28 — Day 28
Trial sites (41)
Facility
City
Region
Status
University of Alabama Hospital
Birmingham
Alabama
Not Yet Recruiting
Community Regional Medical Center
Fresno
California
Recruiting
Long Beach Memorial Medical Center
Long Beach
California
Recruiting
University of California Irvine Medical Center
Orange
California
Recruiting
University of California Davis Medical Center - Pulmonary Medicine
Sacramento
California
Recruiting
Stanford Medical Center
Stanford
California
Recruiting
Denver Health Hospital and Authority
Denver
Colorado
Recruiting
MedStar Washington Hospital Center
Washington D.C.
District of Columbia
Recruiting
Nova Clinical Research
Bradenton
Florida
Recruiting
North Florida / South Georgia Veterans Health System
Gainesville
Florida
Recruiting
Sarasota Memorial Hospital
Sarasota
Florida
Recruiting
St. Luke's Boise Medical Center
Boise
Idaho
Recruiting
Northshore University Healthsystem Research Institute
Evanston
Illinois
Not Yet Recruiting
OSF Saint Francis Medical Center-
Peoria
Illinois
Recruiting
Tufts Medical Center
Boston
Massachusetts
Not Yet Recruiting
Lahey Hospital and Medical Center
Burlington
Massachusetts
Recruiting
University of Michigan Hospital
Ann Arbor
Michigan
Recruiting
Henry Ford Health Hospital
Detroit
Michigan
Recruiting
Mayo Clinic
Rochester
Minnesota
Recruiting
Renown Institute for Heart & Vascular Health
Reno
Nevada
Withdrawn
Robert Wood Johnson Medical School
New Brunswick
New Jersey
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Not Yet Recruiting
Weill Cornell Medical College
New York
New York
Not Yet Recruiting
Montefiore Hospital - Moses Campus
The Bronx
New York
Recruiting
Westchester Medical Center
Valhalla
New York
Not Yet Recruiting
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Recruiting
Durham VA Medical Center
Durham
North Carolina
Recruiting
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS
Durham
North Carolina
Not Yet Recruiting
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Not Yet Recruiting
Cleveland Clinic
Cleveland
Ohio
Not Yet Recruiting
Mercy Health - St. Vincent Medical Center
Toledo
Ohio
Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma
Recruiting
Oregon Health and Science University
Portland
Oregon
Recruiting
Medical University of South Carolina (MUSC)
Charleston
South Carolina
Recruiting
Vanderbilt University Medical Center
Nashville
Tennessee
Recruiting
Baylor All Saints Medical Center
Fort Worth
Texas
Recruiting
Baylor St Luke's Medical Center
Houston
Texas
Not Yet Recruiting
Houston Methodist Hospital
Houston
Texas
Not Yet Recruiting
Intermountain Medical Center
Murray
Utah
Recruiting
University of Virginia Health System
Charlottesville
Virginia
Not Yet Recruiting
+ 1 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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