Applying Lessons Learned From COVID-19 Therapeutic Trials to Improve Future ALI/ARDS Trials

Overview

Journal Open Forum Infect Dis

Specialty Infectious Diseases

Date 2022 Aug 19

PMID 35983268

Authors

Qun Wu

Meghan E Pennini

Julie N Bergmann

Marina L Kozak

Kristen Herring

Kimberly L Sciarretta

Kimberly L Armstrong

Affiliations

Soon will be listed here.

Abstract

Host-directed therapeutics targeting immune dysregulation are considered the most promising approach to address the unmet clinical need for acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) related to coronavirus disease 2019 (COVID-19). To better understand the current clinical study landscape and gaps in treating hospitalized patients with severe or critical COVID-19, we identified COVID-19 trials developing host-directed therapies registered at ClinicalTrials.gov and discussed the factors contributing to the success vs failure of these studies. We have learned, instead of the one-size-fits-all approach, future clinical trials evaluating a targeted immunomodulatory agent in heterogeneous patients with ALI/ARDS due to COVID-19 or other infectious diseases can use immune-based biomarkers in addition to clinical and demographic characteristics to improve patient stratification and inform clinical decision-making. Identifying distinct patient subgroups based on immune profiles across the disease trajectory, regardless of the causative pathogen, may accelerate evaluating host-directed therapeutics in trials of ALI/ARDS and related conditions (eg, sepsis).

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