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.
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 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.
Parallel
Cohort A: vilobelimab
DrugAdministered 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: placebo
DrugAdministered 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: paridiprubart
DrugAdministered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1
Cohort B: placebo
DrugAdministered as a single IV dose of placebo on Day 1
Cohort C: bevacizumab
DrugAdministered as a single IV dose of 500 mg on Day 1
Cohort C: placebo
DrugAdministered as a single IV dose of placebo on Day 1
6
Treatment groupsSee each treatment group below.
All-cause mortality (ACM) rate at Day 28
ACM at Day 60 and Day 90
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).
Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)
Incidence of new invasive mechanical ventilation use during the study up to and including Day 28
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PPD Development, LP
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
InflaRx GmbH
Collaborator
Edesa Biotech Inc.
Collaborator
Genentech, Inc.
Collaborator
