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

Qun Wu1, Meghan E Pennini2, Julie N Bergmann3

  • 1Influenza and Emerging Infectious Diseases Division (IEIDD), Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), Washington DC, USA.

Open Forum Infectious Diseases
|August 19, 2022
PubMed

Insights

Host-directed therapies show promise for acute lung injury (ALI)/acute respiratory distress syndrome (ARDS). Future trials should use immune biomarkers for better patient selection in COVID-19 and other infections.

Area of Science:

  • Immunology
  • Pulmonology
  • Infectious Diseases

Background:

  • Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) present a significant clinical challenge, particularly in severe COVID-19.
  • Host-directed therapeutics targeting immune dysregulation are a key focus for treating these conditions.

Purpose of the Study:

  • To analyze the landscape of clinical trials for host-directed therapies in COVID-19-related ALI/ARDS.
  • To identify factors influencing the success or failure of these therapeutic studies.
  • To propose strategies for improving future clinical trial design.

Main Methods:

  • Systematic identification of COVID-19 trials developing host-directed therapies registered on ClinicalTrials.gov.
  • Review and discussion of factors contributing to study outcomes.
  • Analysis of patient stratification methods in current ALI/ARDS research.

Main Results:

  • The "one-size-fits-all" approach is insufficient for heterogeneous ALI/ARDS patient populations.
  • Immune-based biomarkers, alongside clinical data, can enhance patient stratification.
  • Distinct immune profiles across disease trajectories can be identified regardless of the pathogen.

Conclusions:

  • Future ALI/ARDS trials, including those for COVID-19 and sepsis, should incorporate immune biomarkers for precise patient stratification.
  • Targeted immunomodulatory agents can be more effectively evaluated in well-defined patient subgroups.
  • Personalized therapeutic strategies are crucial for improving outcomes in critical respiratory illnesses.
Keywords:
COVID-19acute respiratory distress syndromeclinical trialhost-directed therapysepsis

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