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BAY1097761 Active Dose 2 for Acute Respiratory Distress Syndrome (SEAL Trial)

Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 28, day 60 and day 90
Awards & highlights

SEAL Trial Summary

This trial will compare the safety and effectiveness of two different doses of a new drug, compared to a placebo, in people with a type of lung failure called ARDS.

Eligible Conditions
  • Acute Respiratory Distress Syndrome (ARDS)

SEAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 28, day 60 and day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 28, day 60 and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
VFS in Part B participants
Secondary outcome measures
All-cause mortality in Part A and Part B participants
CUI in Part A participants
Integrated analysis on VFS invoving all participants from Part A and Part B
+4 more

SEAL Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B - Active Drug DoseExperimental Treatment2 Interventions
Participants will receive Active Drug 1 or 2 for a maximum of 14 days in study phase Part B
Group II: Part A - Active Drug Dose 2Experimental Treatment1 Intervention
Participants will receive Active Drug Dose 2 for a maximum of 14 days in study phase Part A
Group III: Part A - Active Drug Dose 1Experimental Treatment1 Intervention
Participants will receive Active Drug Dose 1 for a maximum of 14 days in study phase Part A
Group IV: Part A - PlaceboPlacebo Group1 Intervention
Participants will receive Placebo for a maximum of 14 days in study phase Part A
Group V: Part B - PlaceboPlacebo Group1 Intervention
Participants will receive Placebo for a maximum of 14 days in study phase Part B

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Who is running the clinical trial?

BayerLead Sponsor
2,247 Previous Clinical Trials
25,333,495 Total Patients Enrolled
~19 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
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