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NCT04481685 · ClinicalTrials.gov registry record · Phase 2

A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19)

A Phase 2 study of COVID-19, sponsored by University of Kansas Medical Center.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT04481685: Completed Phase 2 study of COVID-19, sponsored by University of Kansas Medical Center.

NCT04481685 is a Phase 2 study of COVID-19 that has completed, run by University of Kansas Medical Center. The registered enrollment target is 20 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04481685, a Phase 2 study of COVID-19, has completed, sponsored by University of Kansas Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Proportion of responders on Day 14 defined as all subjects who are alive, free of respiratory failure (do not require supplemental oxygen) and do not experience negative intercurrent events by Day 14 of the trial will be considered responders, as assessed by participant medical records.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG ATI-450

Study Locations (1)

Kansas

  • The University of Kansas Medical Center - Kansas City

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-07-20
Est. Completion 2021-06-01
Phase Phase 2
University of Kansas Medical Center

408 total trials

What the finished NCT04481685 record still lists

NCT04481685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).

The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04481685 reports a single indexed study location in Kansas.

Frequently Asked Questions

What is clinical trial NCT04481685 about?

NCT04481685 is a clinical study titled "A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19)". 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 pathwa...

What is the current status of trial NCT04481685?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-07-20. Estimated completion is 2021-06-01.

What conditions does trial NCT04481685 study?

This clinical trial studies the following conditions: COVID-19.

What interventions are being tested in trial NCT04481685?

The interventions under investigation include: Placebo (DRUG), ATI-450 (DRUG).

Who is sponsoring clinical trial NCT04481685?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04481685 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for COVID-19

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04481685's enrollment target sits among peer trials

20 279th of 298 higher than 14 of 298 other COVID-19 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04481685, the US trial registry maintained by the National Library of Medicine. NCT04481685 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.