Demographic Representation of a Decentralized Long COVID Trial: A Comparison with the 2023 National Health Interview Survey

ImportanceClinical trials can be a chokepoint to progress in medicine. They are commonly expensive, slow, and not participant-centric. Ensuring patient-centric, equitable trials with diverse demographic representation is essential for developing generalizable treatments and reducing healthcare disparities. Thus, there is an urgent need to test new ways of conducting clinical trials. The PAX LC trial is a novel Phase II decentralized, digital, and participant-centric double-blind randomized trial of Paxlovid for long COVID and is a test case for a new approach. There is a need to determine how well the trial enrolled a representative population with long COVID. ObjectiveTo compare the demographic characteristics of participants in the PAX LC trial with those reported in the National Health Interview Survey (NHIS) to assess how well the decentralized recruitment reflects the broader population in the US with long COVID. DesignDescriptive analysis comparing 2 databases: a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled trial conducted in community-dwelling adults with long COVID, and a nationwide observational cross-sectional survey. SettingDecentralized clinical trial with participants recruited from 48 contiguous states in the US. The NHIS survey participants were recruited from all 50 states. Participants100 highly symptomatic adults with long COVID in the PAX LC trial, compared with 575 from NHIS. Intervention(s) or Exposure(s)None. Main Outcome(s) and Measure(s)Percentage distribution by age group, gender, race and ethnicity, and region for each group. ResultsPAX LC included 100 participants and NHIS 575, with PAX LC participants being younger (median 42 vs. 53 years). There was an equal proportion of women. Non-Hispanic White representation was higher in PAX LC (89% vs. 61% in NHIS), while the Hispanic and Non-Hispanic Black groups were underrepresented (5% vs. 20% and 1% vs. 12%, respectively). More PAX LC participants were from the Northeast (51% vs. 15%) due to earlier enrollment in this region. Conclusions and RelevanceThe PAX LC trial highlights the potential of decentralized trials to achieve geographic diversity and balanced age and gender representation. However, to maximize the benefits of this approach, further efforts are warranted to improve racial and ethnic diversity. Trial RegistrationNCT05668091.