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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

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,229 Previous Clinical Trials
25,325,347 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment need more participants?

"Yes, this is an ongoing clinical trial that was originally posted on July 7th 2020. The listing was last updated on November 11th, 2020."

Answered by AI

Is this study prevalent in North America?

"Currently, this trial is being hosted at 11 different hospitals including North York General Hospital in Toronto, Vancouver Island Health Authority - Royal Jubilee Hospital in Victoria, and CIUSSS de l'Est-de-l'Ile de Montreal,Installation Maisonneuv in Montreal."

Answered by AI

What are the potential risks associated with taking BAY1097761 Active Dose 2?

"BAY1097761 Active Dose 2 is only in Phase 2 of clinical trials, so there is not much data on its efficacy. However, it did score a 2 for safety."

Answered by AI

To what extent is this research being conducted on test subjects?

"466 patients are required to carry out this trial according to the current inclusion criteria. The sponsor, Bayer, will be running the study at North York General Hospital in Toronto, British Columbia and Vancouver Island Health Authority - Royal Jubilee Hospital in Victoria, Quebec."

Answered by AI
~19 spots leftby Mar 2025