Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Posted on by Elizabeth Mccamic

Speaker

Kanecia Zimmerman, MD, PhD, MPH
Associate Professor of Pediatrics
Duke Clinical Research Institute
Duke University School of Medicine

 

Keywords

COVID-19, RECOVER, Clinical Trials

 

Key Points

  • Long COVID is a set of multiple conditions with diverse clinical manifestations that can affect every major organ/tissue system, reflecting varied potential underlying and co-existing causes.
  • There are many hypothesized causes that may co-exist in the same patient, such as persistent virus or antigens, reactivation of other viruses, uncontrolled immune responses, damage to a wide range of organs and tissues, and injury to blood vessels and abnormal blood clotting. This broad set of clinical conditions and varied underlying causes underscore the need for testing a broad portfolio of therapeutic agents.
  • RECOVER is a patient-centered, integrated, adaptive research network. The goals of RECOVER is to understand how people are recovering from COVID and changes in our bodies over time; define risk factors, number of people getting Long COVID, and if there are specific different Long COVID types; study how Long COVID progresses over time and how that may relate to other illnesses; and identify possible treatments to help with Long COVID symptoms.
  • RECOVER has used cohort data to identify major symptom clusters and develop 5 platform protocols that will investigator priority symptom clusters and their causes; test known and novel interventions across domains; and evaluate treatments to improve Long COVID symptoms.
  • The 5 platform protocols are integrated rather than siloed, disparate studies to achieve efficiencies, allow researchers to rapidly assess targeted therapeutics and pivot as needed to new treatment arms, maximize knowledge gained from patient participation, and to enable cross-trial analysis and accelerated knowledge acquisition.
  • The 5 trials, RECOVER-VITAL, RECOVER-AUTONOMIC, RECOVER-SLEEP, RECOVER-NEURO, and RECOVER-ENERGIZE, will enroll about 2,600 total participants, and each trial will include between 25-100 sites. The first trial will begin enrolling in July 2023.

Learn more

Visit https://recovercovid.org

Discussion Themes

– What experts are being convened for the different trials? It’s all over the place. We have people with experience with post-viral symptoms, treating ME/CFS, general COVID knowledge, biomarker experience, clinical trials, patient-reported outcomes, and more.

– As people think about the health measures and outcomes, can you describe the process for how to understand and select those types of measures? It was such an iterative process to get to where we are. People with experience to prior disease that might be similar is where we started. Can we use measures that have been used previously for those populations and if we can how do we tweak them to make sure they are valid within this population? Prior information, data and experience and then adapt it for patients with PASC.

-While the pandemic is transitioning from pandemic to endemic state, do you see any signs that PASC will go away? No, there are no signs PASC is going away. It seems the most severely affected people came from the early waves of COVID. Over time the epidemiology has changed some for those people with PASC, but there are still people who are still symptomatic and want answers.

Tags

#pctGR, @Collaboratory1