Study of Varespladib in Patients Hospitalized With Severe COVID-19

(STAIRS Trial)

Recruiting at 6 trial locations

Overseen By Jeff Lickteig, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ophirex, Inc.

Must not be taking: Investigational medications, CNS depressants

Disqualifiers: Mild, moderate, critical COVID-19, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 61

Duration: 1 week

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have taken investigational medications recently, you may need to wait before enrolling.

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Participant has a positive virologic nucleic acid amplification test (NAAT) indicating SARS-CoV-2 infection in a sample collected <72 hours prior to randomization.

Participant provides informed consent prior to initiation of any study procedures.

Participant agrees to not participate in another clinical trial for the treatment of COVID 19 or SARS-CoV-2 through Day 28.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varespladib or placebo in addition to standard of care for 7 days

1 week

Daily visits while hospitalized, in-person visits on Days 1, 4, 7, 14, and 28

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Regular visits up to Day 60, including phone or ePRO visits

Treatment Details

Interventions

• Placebo
• Varespladib

Participant Groups

Group I: Varespladib: 250mg BID (Part 2 of trial) Experimental Treatment 1 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 TID Experimental Treatment 1 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 + placebo Experimental Treatment 2 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 + placebo Experimental Treatment 2 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: Placebo Placebo Group 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Ophirex, Inc.

Lead Sponsor

Trials

3

Recruited

250+

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD