Varespladib for COVID-19
(STAIRS Trial)
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-19.12345Why 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.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive varespladib or placebo in addition to standard of care for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Varespladib
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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.
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.
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, and in the afternoon.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ophirex, Inc.
Lead Sponsor
Premier Research
Collaborator
Premier Research Group plc
Collaborator
Premier Research Group plc
Industry Sponsor
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
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 ...
Varespladib (LY315920) and Methyl ...
Overall, results suggest that the two forms of Varespladib are effective in abrogating, or delaying, neurotoxic manifestations induced by ...
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.
Varespladib (LY315920) neutralises phospholipase A2 ...
Our results demonstrate that varespladib strongly neutralises the prothrombinase-inhibiting effects of all venoms tested in this study.
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 ...
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=AfmBOopQfyhXgMY950CFBzRgn5HEjQDbmy20WwRD66HcpuZeNPQRXqGNVarespladib 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 ...
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_dhcv8gLY315920 (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 ...
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.
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