← Back to Search

NLRP3 Inhibitor

dapansutrile capsules for Cytokine Release Syndrome

Phase 2

Waitlist Available

Research Sponsored by Olatec Therapeutics LLC

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 day 8, day 15, day 29, day 45

Awards & highlights

Study Summary

This trial is studying whether the NLRP3 inhibitor, dapansutrile, can help to treat moderate COVID-19 symptoms and early cytokine release syndrome.

Eligible Conditions

Cytokine Release Syndrome
Coronavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 8, day 15, day 29, day 45

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 8, day 15, day 29, day 45

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8, day 15, day 29, day 45 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of subjects with clinical deterioration

Secondary outcome measures

Change in ALT

Change in AST

Change in C3a

+39 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: dapansutrile capsulesExperimental Treatment1 Intervention

Subjects will receive 4 x 250mg dapansutrile capsules BID for 14 days with an initial (first) dose of 8 x 250mg (2000 mg) administered at the study site on Day 1 (Day 1 dose may be 3000 mg).

Group II: placebo capsulesPlacebo Group1 Intervention

Subjects will receive 4 placebo capsules BID for 14 days with an initial (first) dose of 8 capsules administered at the study site on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

dapansutrile capsules

2018

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Olatec Therapeutics LLCLead Sponsor

9 Previous Clinical Trials

1,010 Total Patients Enrolled

CTI Clinical Trial and Consulting ServicesOTHER

34 Previous Clinical Trials

3,686 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 is the United States Federal Drug Administration's stance on dapansutrile capsules?

"While there is some data supporting the safety of dapansutrile capsules, it did not receive a high score because this medication has only been tested in Phase 2 trials."

Answered by AI

Does this research stand alone or has similar work been conducted in the past?

"As of right now, 3 clinical trials involving dapansutrile capsules are ongoing in 13 cities across 3 nations. The first such study occurred in 2018 and was sponsored by Olatec Therapeutics LLC. This initial trial had 10 patients and finished its Phase 2 drug approval process. In the years since 2018, an additional 10 similar trials have been completed successfully."

Answered by AI

Are there any similar research projects to dapansutrile capsules?

"dapansutrile capsules was initially studied in the year 2018 at Radboudumc. So far there are 10 completed clinical trials. There are currently 3 active studies, with many of these trials being performed out of Las Vegas, Nevada."

Answered by AI

How many volunteers will be given lenalidomide in this experiment?

"That is correct, the online information indicates that this research is ongoing and looking for more participants. The clinical trial was first put up on 9/25/2020, with the most recent update being 9/16/2022. In total, they are trying to enroll 80 individuals from 4 different locations."

Answered by AI

How many different facilities are in charge of this research project?

"4 clinical trial sites are currently operational, with more centres located in Las Vegas, Coral Gables, and Houston. If you decide to participate in this study, please choose the location nearest you to reduce travel costs and time commitments."

Answered by AI

Are new volunteers being enrolled in this clinical trial at this time?

"That is accurate. According to the information available on clinicaltrials.gov, this trial was posted on September 25th, 2020 and is currently recruiting patients. The study needs 80 individuals from 4 medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome

2020. "Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04540120.