Trial results for an observational study on COVID-19 outcomes in veterans were posted on ClinicalTrials.gov on 2025-08-07, involving 479 participants.
Background
COVID-19, caused by the SARS-CoV-2 virus, has been associated with a range of long-term health issues affecting various organ systems and functional capabilities. Understanding these long-term outcomes is critical for patient care and public health planning, particularly in vulnerable populations such as veterans. Instrumental Activities of Daily Living (I/ADL) and Activities of Daily Living (ADL) scores are widely used measures to assess an individual's ability to perform essential daily tasks, providing insight into functional independence and overall quality of life. This study aimed to examine these long-term outcomes in veterans who were infected with SARS-CoV-2 compared to those who were not, utilizing electronic health record information and structured surveys.
Trial design
This completed observational study, titled "COVID-19 Observational Research Collaboratory", enrolled 479 participants. The study investigated long-term outcomes in veterans with COVID-19 and SARS-CoV-2 Infection compared to uninfected veterans. The primary objective was to examine long-term outcomes using electronic health record information and structured surveys. The study design included two main groups: Veterans who tested positive for COVID-19 (Case) and Veterans who did not test positive for COVID-19 (Comparator).
Key results
The study reported several key measurements and analyses related to Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) scores:
- For Veterans who tested positive for COVID-19 (Case), the mean I/ADL score was 3.40 (Standard Deviation 3.18).
- For Veterans who did not test positive for COVID-19 (Comparator), the mean I/ADL score was 3.05 (Standard Deviation 3.09).
- In another measurement, for Veterans who tested positive for COVID-19 (Case), the mean I/ADL score was 3.50 (Standard Deviation 3.40).
- For Veterans who did not test positive for COVID-19 (Comparator), the mean I/ADL score was 3.40 (Standard Deviation 3.30).
- A further measurement showed for Veterans who tested positive for COVID-19 (Case), the mean I/ADL score was 3.31 (Standard Deviation 3.39).
- For Veterans who did not test positive for COVID-19 (Comparator), the mean I/ADL score was 2.98 (Standard Deviation 2.88).
- Finally, for Veterans who tested positive for COVID-19 (Case), the mean I/ADL score was 3.60 (Standard Deviation 3.50).
- For Veterans who did not test positive for COVID-19 (Comparator), the mean I/ADL score was 3.30 (Standard Deviation 3.20).
Key analyses using an adjusted linear mixed model (LMM) to model I/ADL scores over time and by COVID-19 status, including fixed effects for patient baseline age, sex, and care assessment needs score, yielded the following:
- An interaction term for time and COVID-19 status showed a parameter value of 0.02 (95.0% Confidence Interval: -0.13 to 0.18), with a p-value of 0.77. This analysis tested the null hypothesis of no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators.
- The mean difference in final I/ADL values was 0.12 (95.0% Confidence Interval: -0.44 to 0.67), with a p-value of 0.6. This analysis also tested the null hypothesis of no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators.
What this means
The results of this observational study indicate that, among the participating veterans, there was no statistically significant difference in the trends of Instrumental Activities of Daily Living (I/ADL) scores over time between those who tested positive for COVID-19 and those who did not. The analyses, which adjusted for baseline age, sex, and care assessment needs, reported p-values of 0.77 for the interaction term (time and COVID-19 status) and 0.6 for the mean difference in final I/ADL values. These findings suggest that, based on the I/ADL measure, COVID-19 infection did not lead to a significant long-term decline in functional independence in this veteran population compared to uninfected controls.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05394025, titled "COVID-19 Observational Research Collaboratory", were posted on 2025-08-07 on clinicaltrials.gov.