Marilyn Bulloch, PharmD, BCPS, FCCM
Dept of Pharmacy Practice
Auburn University Harrison School of Pharmacy
Kimberly, Alabama
Disclosure information not submitted.
John David Abrams
PharmD Candidate
Auburn University
Auburn, Alabama, United States
Disclosure information not submitted.
Luke Hentrich
PharmD Candidate
Auburn University, United States
Disclosure information not submitted.
Title: Evaluation of Therapeutic Clinical Trials Involving Geriatric Patients for COVID-19
Introduction: Geriatric patients have an increased mortality rate from COVID-19. Medications utilized in older adults need to have studies on the safety and efficacy within geriatric populations. This study evaluated clinical trials including patients 65 years and older in the treatment or prevention of COVID-19.
Methods: A literature search was performed using PubMed to identify studies of COVID-19 medications. Inclusion criteria were clinical trials with patients 65 years and older enrolled and medications recommended for use per COVID-19 treatment guidelines. Data was also included from published articles with pertinent data identified from ongoing clinical trials for COVID-19 treatment. Boolean search terms included 24 medications and 3 vaccines. Exclusion criteria were clinical trials not enrolling patients 65 years and older, no primary focus on COVID-19, SARS-CoV-2, or coronavirus, medications recommended against use per treatment guidelines, trials not evaluating medication or vaccine use, journal articles with no full-text, duplicate studies, trial protocols, and articles not published in a peer-reviewed journal.
Results: 151,690 clinical trials on COVID-19, SARS-CoV-2, or coronavirus were identified; 101 met inclusion criteria. Published data from 3 ongoing trials with published results were also included. Mean age of all trials was 56.8 years. Of the included studies, 37.5% conducted a sub-analysis by age. Only 2.9% of studies exclusively evaluated patients 65 years and older. Tocilizumab had the most studies identified while also reporting the most trials with specific adverse events. Bamlanivimab/etesevimab, budesonide, convalescent plasma, and favipiravir demonstrated positive efficacy in randomized clinical trials for geriatrics. Remdesivir and dexamethasone are guideline-recommended for COVID-19 treatment; however, no sub-groups in studies of either found efficacious data in geriatrics. The Ad26.COV2.S, mRNA-1273, and BNT162b2 vaccines demonstrated consistent safety and efficacy in older adults.
Conclusion: Less than 0.3% of studies met inclusion criteria. More data is needed from randomized clinical trials on the safety and efficacy of therapeutic interventions for COVID-19 in geriatric patients. Based on current data, vaccine use should continue to be encouraged in adults 65 years and older.