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News from NIH: Planning for the Next Phase of the RECOVER Initiative
Dear RECOVER & Long COVID Community:
We are writing to let you know about an important evolution in NIH’s operational approach to clinical trials to evaluate therapeutic interventions for Long COVID. The
NIH Researching COVID to Enhance Recovery (RECOVER) Initiative has created a research engine of unprecedented scale and scope, including one of the largest and most diverse Long COVID cohorts in the world. RECOVER is led by three NIH Institutes convened by the NIH Director in 2020 to address the multi-system nature of Long COVID: the National Heart, Lung, and Blood Institute (NHLBI); the National Institute of Allergy and Infectious Diseases (NIAID); and the National Institute of Neurological Disorders and Stroke (NINDS).
To date, research conducted through the RECOVER Initiative has greatly contributed to our understanding of Long COVID, even as the condition has continued to evolve. It also has provided valuable experience in designing and conducting clinical trials to address patient-centered endpoints for this novel and complex condition. Most importantly, we’ve learned from the more than 30,000 people who have volunteered to be part of ongoing RECOVER studies and clinical trials. We are grateful for their continued participation and are looking forward to the valuable results that will emerge when the first round of RECOVER clinical trials is completed.
We are beginning to plan for the next phase of RECOVER clinical trials. We will apply lessons learned from initial RECOVER studies and trials to develop a new program called RECOVER-Treating Long COVID (RECOVER-TLC). As the current RECOVER clinical trials and studies continue, the emerging data will inform the ongoing work of RECOVER-TLC. The new program will be led by NIAID, leveraging its expertise in infectious and immunologic diseases and conditions and its experience in conducting COVID-19 clinical trials.
The new program will provide a clear path for ongoing scientific and community engagement to assess new ideas, identify potential therapeutics and biologics, and execute innovative study designs. Importantly, RECOVER-TLC will provide additional clinical trials capacity, building upon existing RECOVER clinical trial sites to maintain the involvement of investigators and participants who are deeply invested in Long COVID research and clinical care.
To make sure that RECOVER-TLC leverages all that has been learned over the past three years, we will call upon the broad research community to help identify promising therapeutic approaches and propose study designs that will produce results that are needed by those affected by Long COVID. This effort will be modeled on the successful process used in NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program but modified to address newly identified biological mechanisms and unique symptoms associated with Long COVID.
We need your help to make RECOVER-TLC a success. To that end, please save Sept. 23-25 to participate in a RECOVER-TLC kick-off meeting, to be held both in person and virtually. We are inviting Long COVID researchers, healthcare providers, people affected by Long COVID, advocacy organizations, and Federal policymakers to come together to discuss the structure and governance of RECOVER-TLC, assess the current research landscape, and help plan future NIH Long COVID clinical trials.
More details about the meeting agenda and registration information will be coming soon. Be sure to
sign up for email updates to receive the latest updates. We are excited about this new phase and look forward to your active participation and continued partnership.
