CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
ATI-450 +1 moredrug
Likely dose
ATI-450 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04481685
NCT04481685Phase 2Completed
CompareCT.gov

A Double-blind, Randomized, Controlled Trial of ATI-450 in Patients With Moderate-severe COVID-19

University of Kansas Medical Center·interventional·Posted Jul 22, 2020·Updated Jun 4, 2025

In Brief

A Phase 2 clinical trial evaluating ATI-450 and Placebo for Covid19. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 22, 2020
Enrollment StartJul 20, 2020
Primary CompletionFeb 25, 2021
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.9 years ago

Interventions

ATI-450drug

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.

Placebodrug

Placebo pill will be taken twice daily preferably spaced 12 hours apart.