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ATI-450Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2125 Placebo (Plasma-Lyte 148) Wiki 1.00
drug1278 Human umbilical cord derived CD362 enriched MSCs Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.10
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.09
D012128 Respiratory Distress Syndrome, Adult NIH 0.08

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Double-blind, Randomized, Controlled Trial of ATI-450 in Patients With Moderate-severe 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 pathway blockade during active COVID-19 infection in hospitalized participants will result in improvement in respiratory-failure free survival.

NCT04481685 Covid19 Drug: ATI-450 Drug: Placebo

Primary Outcomes

Description: Participants medical record

Measure: Respiratory failure-free survival in participants with moderate-severe COVID-19 who are treated with ATI-450

Time: Study day 14

Secondary Outcomes

Description: Using World Health Organization (WHO) COVID-19 Ordinal scale measuring: Proportion and time to participants with greater than 2 point improvement on the 7 point categorical scale. This scale measures illness severity over time and has a range of 0-7. 0- Uninfected: No clinical or virological evidence of infection. 1- Ambulatory: No limitation of activities. 2- Ambulatory: Limitation of activities. 3- Hospitalized, mild disease: Hospitalized, no oxygen. 4- Hospitalized, mild disease: Oxygen by mask or nasal prongs. 5- Hospitalized, severe disease: Non- invasive ventilation or high- flow oxygen. 6- Hospitalized, severe disease: Intubation and mechanical ventilation. 7- Hospitalized, severe disease: Ventilation + organ support; pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO).

Measure: Change in 7 point-ordinal scale

Time: Baseline, Day 7, Day 14, Day 28 and follow-up up to 9 months

Description: Peripheral capillary pulse oximeter to measure: Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) ratio over time, sustainment of normalization in 24 hours, and relative shifts in SpO2/FiO2 categories (<235, between 235 and 315, greater than 315) over time

Measure: Change in oxygen saturation-normalization

Time: Baseline and continuous throughout hospitalization up to 14 days

Description: Derived from medical record

Measure: Need for advanced respiratory care

Time: Baseline and continuous throughout hospitalization up to 14 days

Description: Noted in participant medical record

Measure: All-cause mortality

Time: Baseline and through day 60

Description: CTCAE v5.0

Measure: Percentage of adverse events (AEs)

Time: Baseline through day 14 or at discharge

Description: CTCAE v5.0

Measure: Percentage of serious adverse events (SAEs)

Time: Baseline through day 14 or at discharge

Description: Standard daily temperature measurement and obtained from participant medical record

Measure: Proportion of participants with normalization of fever for 24 hours

Time: Baseline through day 14 or at discharge

Description: Noted in participant medical record

Measure: Number of participants who develop new bacterial infection

Time: Continuous throughout hospitalization up to 14 days

Description: Noted in participant medical record

Measure: Number of participants who develop new fungal infection

Time: Continuous throughout hospitalization up to 14 days

Description: Noted in participant medical record

Measure: Incidence of Adult Respiratory distress Syndrome (ARDS2)

Time: From day 1 though day 14 or at discharge

Description: Serum collected from blood and assayed on Luminex panel performed by University of Kansas Medical Center (KUMC) Biobanking and Biomarker Validation (BBV) Core

Measure: Change in serum cytokine Interleukin (IL)-6

Time: Baseline, day 3, day 7 (or discharge day 7 and

Description: Serum collected from blood and assayed on Luminex panel performed by KUMC BBV Core

Measure: Change in serum cytokine IL-8

Time: Baseline, day 3, day 7 (or discharge day 7 and

Description: Serum collected from blood and assayed on Luminex panel performed by KUMC BBV Core

Measure: Change in serum cytokines IL-1β

Time: Baseline, day 3, day 7 (or discharge day 7 and

Description: Serum collected from blood and assayed on Luminex panel performed by KUMC BBV Core

Measure: Change in serum cytokine Tumor Necrosis Factor (TNF-α)

Time: Baseline, day 3, day 7 (or discharge day 7 and

No related HPO nodes (Using clinical trials)