Varespladib for COVID-19

(STAIRS Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a drug called varespladib for people hospitalized with severe COVID-19. Participants will receive either varespladib or a placebo (a pill with no active ingredients) alongside their regular treatment to determine if the drug improves their condition. The trial seeks individuals with severe COVID-19 symptoms, such as trouble breathing at rest, who have recently tested positive for the virus. The study aims to determine if varespladib can improve outcomes for these patients. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that varespladib has been tested for conditions like sickle cell disease and heart problems, helping to clarify its safety profile. Varespladib is usually well-tolerated, though it can cause side effects like any treatment.

In previous studies, mild digestive issues were common side effects, while serious side effects were rare. The Drug Safety Monitoring Board (DSMB) monitors safety concerns during studies and takes action to protect participants if necessary.

This is a Phase 2 trial, indicating that varespladib has already demonstrated reasonable safety in earlier trials. This trial aims to provide more information about its tolerability, particularly when used for severe COVID-19. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Varespladib is unique because it targets a specific enzyme called secretory phospholipase A2 (sPLA2), which plays a role in inflammation. Unlike standard treatments for severe COVID-19, which often focus on antiviral activities or immune modulation, Varespladib aims to reduce inflammation directly by inhibiting this enzyme. Researchers are excited about this treatment because it offers a novel approach to potentially decrease the severe inflammatory response seen in COVID-19 patients, which could lead to faster recovery and better outcomes.

What evidence suggests that this trial's treatments could be effective for severe COVID-19?

Research has shown that varespladib, one of the treatments studied in this trial, may help with conditions involving inflammation. It blocks a substance in the body that causes inflammation. This has proven useful in other situations, such as treating snakebites, where it helps stop harmful effects. Although specific data for COVID-19 is limited, the mechanism of varespladib suggests it might reduce inflammation from the virus. Early research in similar conditions supports its potential to improve outcomes. Participants in this trial may receive varespladib or a placebo, along with standard care, to evaluate its effectiveness. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Varespladib

How Is the Trial Designed?

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

Collaborator

Premier Research Group plc

Collaborator

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9695340/

Varespladib in the Treatment of Snakebite Envenoming Additionally, data suggest that snakebite envenoming is disproportionately severe in childhood with worse outcomes, which is likely due to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32093386/

Varespladib (LY315920) and Methyl ... Overall, results suggest that the two forms of Varespladib are effective in abrogating, or delaying, neurotoxic manifestations induced by ...

3. gh.bmj.com gh.bmj.com/content/9/10/e015985

Oral varespladib for the treatment of snakebite envenoming ... Ninety-five patients were randomly allocated to varespladib or placebo. These 95 patients, who form the ITT population, were analysed for efficacy outcomes.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1532045620301186

Varespladib (LY315920) neutralises phospholipase A2 ... Our results demonstrate that varespladib strongly neutralises the prothrombinase-inhibiting effects of all venoms tested in this study.

5. mdpi.com mdpi.com/2072-6651/15/1/22

The BRAVO Clinical Study Protocol: Oral Varespladib for ... Additional patient-reported outcomes include the patient-specific functional scale, the numeric pain rating scale, and the patient global ...

6. chemicalbook.com chemicalbook.com/msds/varespladib.htm

VARESPLADIB - Safety Data Sheet Material Safety Data Sheet or SDS for VARESPLADIB 172732-68-2 from chemicalbook for download or viewing in the browser.

7. medchemexpress.com medchemexpress.com/Varespladib_methyl.html?srsltid=AfmBOopQfyhXgMY950CFBzRgn5HEjQDbmy20WwRD66HcpuZeNPQRXqGN

Varespladib methyl (A-002) | Phospholipase Inhibitor Varespladib methyl. Inquiry Online. Your information is safe with us. ... SAFETY DATA SHEET (SDS). English - EN (252 KB) Français - FR (252 KB) Deutsch ...

8. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Varespladib

Varespladib | C21H20N2O5 | CID 155815 - PubChem - NIH Varespladib has been investigated for the treatment and prevention of Sickle Cell Disease, Vaso-occlusive Crisis, and Acute Coronary Syndrome.

9. caymanchem.com caymanchem.com/product/18267/ly315920?srsltid=AfmBOoqYPNeqblAKEPob6tBV4Ed5tt3JG2ueGysVZ1h_9BlIb_dhcv8g

LY315920 (​Varespladib, CAS Number: 172732-68-2) LY315920. Item No. 18267. LY315920 (​Varespladib, CAS Number: 172732-68-2). Download Product Insert (PDF)Download Safety Data Sheet (SDS) (PDF). 5 mg: $86: In ...

10. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/64/NCT04996264/Prot_000.pdf

Varespladib-methyl PROTOCOL NUMBER: OPX-PR-01 ... The DSMB will evaluate the safety data, including summaries by group, at the intervals specified in the DSMB charter. In case of significant toxicity, the DSMB.