RECRUITING

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

Conditions

Acute Respiratory Distress Syndrome (ARDS)ARDS ARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress Syndrome BARDA JUST BREATHE Acute Respiratory Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-13

Study Completion:2028-02-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06703073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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).	* 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. * Participant is not expected to survive for 72 hours. * Participant has been on invasive mechanical ventilation or ECMO 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. * Participant is undergoing active cancer systemic chemotherapy. * 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: 1. Known active tuberculosis, 2. Known active Hepatitis B, or 3. 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.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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).

* 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.
* Participant is not expected to survive for 72 hours.
* Participant has been on invasive mechanical ventilation or ECMO 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.
* Participant is undergoing active cancer systemic chemotherapy.
* 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:
1. Known active tuberculosis,
2. Known active Hepatitis B, or
3. 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.

Contacts and Locations

Study Contact

Just Breathe Trial Team

CONTACT

Please email

JustBreatheCT.gov_StudyInquiry@ppd.com

Study Locations (Sites)

St. Luke's Boise Medical Center

Boise, Idaho, 83712-6241

United States

Renown Institute for Heart & Vascular Health

Reno, Nevada, 89502-1576

United States

Collaborators and Investigators

Sponsor: PPD DEVELOPMENT, LP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-13

Study Completion Date2028-02-08

Study Record Updates

Study Start Date2025-02-13

Study Completion Date2028-02-08

Terms related to this study

Keywords Provided by Researchers

BARDA
JUST BREATHE
ARDS
Acute Respiratory Distress Syndrome
Acute Respiratory Failure

Additional Relevant MeSH Terms

Acute Respiratory Distress Syndrome (ARDS)
ARDS
ARDS (Acute Respiratory Distress Syndrome)
Acute Respiratory Distress Syndrome