A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronaviru… (NCT04481685) | Clinical Trial Compass
CompletedPhase 2
A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19)
United States20 participantsStarted 2020-07-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved subject informed consent form (ICF) prior to administration of any study-related procedures, or consent from surrogate decision maker when the above criteria cannot be met
* Male or non-pregnant female adult ≥18 years of age at time of enrollment; female patients must have a negative serum pregnancy test at study enrollment
* Has laboratory-confirmed COVID-19 coronavirus infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in oropharyngeal or nasopharyngeal testing within 14 days of hospitalization. An additional 24-hour COVID-19 PCR test will be performed at KUMC. Patients outside of KUMC will have their samples sent to KUMC as a Central Lab for test processing
* Hospitalized as a result of symptoms and signs related to COVID-19 infection, and ≤14 days since positive test
* Evidence of hypoxic respiratory failure: SpO2≤93% on room air, or SpO2 \>93% requiring ≥ 2 Liters (L) O2, or Pa02/Fi02 ratio \<300 Millimeter of Mercury (mmHg), or tachypnea (respiratory rate \> 30 breaths/min)
* Evidence of pulmonary involvement by: chest imaging or pulmonary exam
* Previous use of hydroxychloroquine or chloroquine is allowed in this study
* Adequate organ function per laboratory tests
* Females of child-bearing potential and males with partners of child-bearing potential must agree to practice sexual abstinence or to use the for…
What they're measuring
1
Respiratory Failure-free Survival in Participants With Moderate-severe COVID-19 Who Are Treated With ATI-450