Expanding the breadth and quality of Long COVID clinical trials is a major priority at PLRC. Below is our work in this field, encompassing study design, drug candidate selection including repurposed drug identification, advisement on trials, funding, and recruitment.
Trial Design, Funding, Recruitment, and Drug Candidate Identification
- PLRC funded the OUTSMART-LC trial (UCSF), the first monoclonal antibody trial for Long COVID.
- PLRC worked on trial design for the REVERSE-LC Long COVID trial on baricitinib (Vanderbilt), a JAK inhibitor that decreases mortality in severe COVID.
- PLRC provided recruitment for the ADDRESS-LC Long COVID trial on bezisterim (Biovie), a blood brain barrier-permeable molecule currently in studies for Alzheimer’s and Parkinson’s.
- PLRC worked on an EHR-based trial emulation for Paxlovid with N3C (National COVID Cohort Collaborative).
- PLRC published a case series on the use of extended-course Paxlovid for Long COVID.
- PLRC works with CURE-ID, an FDA/NIH team to identify repurposed drugs for Long COVID and other illnesses.
- PLRC participated on the antiviral, immunomodulatory, and neurological working groups for candidate identification for RECOVER-TLC‘s second round of trials.
Publications
- 2026, The Lancet: “Recommended long COVID outcome measures and their implications for clinical trial design, with a focus on post-exertional malaise.”
- 2026, The Lancet: “Negative results in long COVID clinical trials: choosing outcome measures for a heterogeneous disease” (open version available here)
- 2024, Life Sciences: “Designing and optimizing clinical trials for long COVID“
- 2024, STAT News: “Long Covid patients deserve to try off-label drugs“
- 2024, Life Sciences: “Using real-world data to accelerate the search for long COVID therapies“
- 2023, Medscape: “Clinical Trials: Top Priority for Long Covid” (open version available here)
Guidance and Presentations
- March 2026, PLRC responded to the RECOVER-TLC’s decision to retain dosage and titration schedule for their LDN trial, despite public feedback strongly recommending adjustments.
- September 2025: PLRC gave multiple presentations at the 2nd RECOVER-TLC meeting.
- Five equity challenges and possible solutions in Long COVID clinical trials by Dr. Letícia Soares (Video, Presentation slides)
- Ethics in Long COVID Research Design by V. Copeland, Ph.D, MSW (Video, Presentation slides)
- Patient Perspective: REVERSE-LC Trial by Michael Sieverts (Video, Presentation slides)
- August 2025: PLRC participated in a meeting during Keystone Conference on FDA approval and pharma involvement in Long Covid.
- November 2024: PLRC provided trial design information, including therapeutics and biomarkers for the NIH’s RFI on RECOVER-TLC.
- September 2024: PLRC gave multiple presentations at the 1st RECOVER-TLC meeting.
- Selecting & Prioritizing Interventions Current Landscape by Julia Moore Vogel, PhD
- How Do We Get from Here to the Next Patient-Centered Long COVID Clinical Trials by Lisa McCorkell, MPP (Presentation slides)
- RECOVER-TLC Trial Design Challenges: Endpoints by Alison Cohen, PhD, MPH (Presentation slides)
- June 2023: PLRC provided a public comment in response to the FDA’s Patient-Focused Drug Development event.
- April 2023: PLRC presented at the FDA meeting on Patient-Focused Drug Development in Long Covid (video available here).
- 2022-2024, PLRC maintained an updated list of recommended drug candidates for trials, which was used in discussions with NIH, research groups, and pharmaceutical companies interested in running Long COVID trials.