The Current Mismatch Between COVID-19 Clinical Trial Design and the Evolving Profile of Hospitalized Patients: A Retrospective Cohort Analysis

Rocio Montejano; Alfredo Soler-Carracedo; Alberto M Borobia; Alejandro Martin-Quiros; David Grandioso; Carlos Cañada; Alicia Roman; Jose R Arribas

doi:10.1093/cid/ciad655

The Current Mismatch Between COVID-19 Clinical Trial Design and the Evolving Profile of Hospitalized Patients: A Retrospective Cohort Analysis

Clin Infect Dis. 2024 Apr 10;78(4):918-921. doi: 10.1093/cid/ciad655.

Authors

Rocio Montejano¹, Alfredo Soler-Carracedo², Alberto M Borobia³, Alejandro Martin-Quiros⁴, David Grandioso⁵, Carlos Cañada⁴, Alicia Roman⁴, Jose R Arribas⁶

Affiliations

¹ Infectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, Instituto de Investigación del Hospital Universitario La Paz, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Madrid, Spain.
² Clinical Trial Unit, Clinical Pharmacology Department, La Paz University Hospital, Instituto de Investigación del Hospital Universitario La Paz, Madrid, Spain.
³ Clinical Pharmacology Department, La Paz University Hospital, Instituto de Investigación del Hospital Universitario La Paz, School of Medicine, Autonomous University of Madrid, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Madrid, Spain.
⁴ Emergency Department, La Paz University Hospital, Instituto de Investigación del Hospital Universitario La Paz, Madrid, Spain.
⁵ Microbiology Department, La Paz University Hospital, Madrid, Spain.
⁶ Infectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, Instituto de Investigación del Hospital Universitario La Paz, School of Medicine, Autonomous University of Madrid, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Madrid, Spain.

PMID: 37882613
DOI: 10.1093/cid/ciad655

Abstract

Evaluating 100 adult coronavirus disease 2019 (COVID-19) patients at a Madrid hospital, we identified a mismatch between current clinical trial designs and the evolving profile of hospitalized patients. Most patients were ineligible due to design constraints, suggesting a need to rethink trial criteria for a more accurate representation of the hospitalized COVID-19 cohort.

Keywords: COVID-19; Patient Eligibility; Retrospective Analysis; clinical trial; hospitalized patients.

MeSH terms

Adult
COVID-19*
Clinical Trials as Topic
Cohort Studies
Humans
Retrospective Studies
SARS-CoV-2