Trials / Completed
CompletedNCT04481685
A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19)
A Double-blind, Randomized, Controlled Trial of ATI-450 in Patients With Moderate-severe COVID-19
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
COVID-19 morbidity and mortality has been associated with Cytokine Release Syndrome (CRS) and Acute Respiratory Distress Syndrome (ARDS). ATI-450 is an oral small molecule MAPKAPK2 (MK2) inhibitor that potently inhibits multiple inflammatory cytokines. The investigator hypothesizes that MK2 pathway blockade during active COVID-19 infection in hospitalized participants will result in improvement in respiratory-failure free survival.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATI-450 | 50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently. |
| DRUG | Placebo | Placebo pill will be taken twice daily preferably spaced 12 hours apart. |
Timeline
- Start date
- 2020-07-20
- Primary completion
- 2021-02-25
- Completion
- 2021-06-01
- First posted
- 2020-07-22
- Last updated
- 2025-06-04
- Results posted
- 2025-06-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04481685. Inclusion in this directory is not an endorsement.