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Varespladib for COVID-19 (STAIRS Trial)

Phase 2
Waitlist Available
Research Sponsored by Ophirex, Inc.
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 from baseline through day 60
Awards & highlights

Summary

This trial tests the safety and effectiveness of an oral medication called varespladib in patients with severe COVID-19. It targets hospitalized patients to help reduce lung damage and inflammation caused by the virus. Varespladib works by blocking an enzyme that contributes to these issues.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through day 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Respiratory Failure
Secondary study objectives
Changes in 12-lead ECGs
Changes in clinical laboratory evaluations: chemistry
Changes in clinical laboratory evaluations: coagulation
+33 more
Other study objectives
Activity of sPLA2 within blood samples collected as clinically required from treatment initiation to Day 28 after randomization
Changes in PK parameters: area-under-the-curve (AUC)
Changes in PK parameters: maximum concentration (Cmax)
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Varespladib: 250mg BID (Part 2 of trial)Experimental Treatment1 Intervention
Dose chosen for Part 2 was twice a day dosing. For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, and in the evening.
Group II: Varespladib: 250 mg TIDExperimental Treatment1 Intervention
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Group III: Varespladib: 250 mg QD + Placebo + placeboExperimental Treatment2 Interventions
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Group IV: Varespladib: 250 mg BID + placeboExperimental Treatment2 Interventions
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Group V: PlaceboPlacebo Group1 Intervention
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Group VI: Placebo (Part 2 of trial)Placebo Group1 Intervention
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, and in the afternoon.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Ophirex, Inc.Lead Sponsor
2 Previous Clinical Trials
236 Total Patients Enrolled
Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
73,851 Total Patients Enrolled
~4 spots leftby Sep 2025
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