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NCT04540120 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome
A Phase 2 study, sponsored by Olatec Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT04540120 is a Phase 2 study that was terminated before completion, run by Olatec Therapeutics. The registered enrollment target is 49 participants.
The verdict
NCT04540120, a Phase 2 study, was terminated before completion, sponsored by Olatec Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of orally administered NLRP3 inhibitor, dapansutrile, for the treatment of moderate COVID-19 symptoms and early cytokine release syndrome (CRS) in patients with confirmed SARS-CoV-2 infection and moderate symptoms. Coronavirus disease 2019 (COVID-19) is caused by infection from a new strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 is characterized by fever, cough and shortness of breath, which in certain patients can lead to systemic organ failure and mortality. The data show that SARS-CoV-2 activates the innate immune signaling sensor NLRP3. Activation of NLRP3 initiates the cytokine release syndrome (CRS), which includes the production of primary cytokine, IL-1, triggering an intense inflammatory response that is prevalent in symptomatic COVID-19 patients. When CRS advances further to a fulminant 'cytokine storm', the data show that respiratory distress syndrome and multiple-organ failure take place. A specific inhibitor of NLRP3, dapansutrile may reduce or prevent the hyperinflammation associated with CRS by inhibiting the production of IL-1β early to arrest the progression to a severe 'cytokine storm.' The end result would be a reduction in the need for COVID-19 patients to receive intensive medical treatment, allowing for fewer hospitalizations, administration of mechanical ventilation and deaths.
Interventions
- DRUG placebo capsules
- DRUG dapansutrile capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2022-07-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04540120
The ClinicalTrials.gov registry entry for NCT04540120 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Olatec Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo capsules is the first listed.
NCT04540120 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04540120 about?
NCT04540120 is a clinical study titled "Safety and Efficacy of Dapansutrile for Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome". The purpose of this study is to assess the safety and efficacy of orally administered NLRP3 inhibitor, dapansutrile, for the treatment of moderate COVID-19 symptoms and early cytokine release syndrome (CRS) in patients with confirmed SARS-CoV-2 infection and moderate symptoms. Coronavirus disease 2...
What is the current status of trial NCT04540120?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2020-09-24. Estimated completion is 2022-07-28.
What interventions are being tested in trial NCT04540120?
The interventions under investigation include: placebo capsules (DRUG), dapansutrile capsules (DRUG).
Who is sponsoring clinical trial NCT04540120?
This trial is sponsored by Olatec Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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