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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

STAIRS Trial Summary

This trial is testing if a drug called varespladib can help treat severe COVID-19. The trial is double-blind, meaning neither the patients nor the doctors will know who is receiving the drug or the placebo.

Eligible Conditions

COVID-19

STAIRS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through day 60

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Respiratory Failure

Secondary outcome measures

Changes in 12-lead ECGs

Changes in clinical laboratory evaluations: chemistry

Changes in clinical laboratory evaluations: coagulation

+34 more

Other outcome measures

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

STAIRS 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

Do I qualify?Apply below to find out

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

69,357 Total Patients Enrolled

Frequently Asked Questions

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

What other Varespladib research studies have been completed in the past?

"Varespladib was first studied in the year 2021 at Westchester Research Center. Since then, a total of 18293 studies have been completed with 2 more currently active. Many of these trials take place in Tulsa, Oklahoma."

Answered by AI

Are people with the qualifying medical conditions able to enroll in this study at this time?

"Unfortunately, this particular study is not enrolling patients at the moment. According to the website clinicaltrials.gov, which last updated information on September 19th 2022, this trial was first posted on June 30th 2021. However, there are many other opportunities to participate in similar trials; 2586 studies are currently recruiting patients."

Answered by AI

How many people are the most that will be included in this test trial?

"This particular trial is not recruiting at this time, as the last edit was on September 19th, 2022. However, there are presently 2584 other trials actively recruiting patients with severe acute respiratory syndrome and 2 Varespladib trials that are looking for patients."

Answered by AI

Across how many different treatment centers is this experiment being conducted?

"In total, there are 8 sites conducting this research project. They are University of Miami Miller School of Medicine, Ascension St. John Clinical Research Institute, Cooper University Hospital, and 5 other locations."

Answered by AI

Has Varespladib been cleared by the FDA?

"Varespladib is a Phase 2 medication, so while there is some data supporting its safety, there is no evidence that it is an effective treatment. Our team at Power gave it a score of 2."

Answered by AI

What are the unique aspects of this research project?

"Varespladib was first trialled in 2021 by Ophirex, Inc. and has since been approved for Phase 2 drug trials. Currently, there are two active studies involving Varespladib being conducted across 21 cities in 2 separate countries."

Answered by AI

Does the age limit for this experiment extend to those over 79 years old?

"This particular study only enrolls patients that are between 18 to 80 years old. However, there are 536 clinical trials for minors and 2012 for senior citizens."

Answered by AI