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

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. 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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Cohort A: vilobelimab

  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)

• Drug
  Cohort A: placebo

  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)

• Drug
  Cohort B: paridiprubart

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

• Drug
  Cohort B: placebo

  Administered as a single IV dose of placebo on Day 1

• Drug
  Cohort C: bevacizumab

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

• Drug
  Cohort C: placebo

  Administered as a single IV dose of placebo on Day 1

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