The RECOVER-Treating Long COVID initiative is set to begin enrolling participants in new clinical trials this summer, which will mark nearly two years after the National of Institutes of Health (NIH) effort launched with promises to deliver greater urgency for this chronic disease impacting tens of millions of Americans.
An offshoot of the NIH’s larger RECOVER program, RECOVER-TLC started in September 2024 following patient advocacy for more, and faster, dedicated research into potential treatments. The initiative tentatively plans to begin enrolling participants for two new trials in summer 2026, one testing low-dose naltrexone in children and young adults and one testing the glucagon-like peptide-1 receptor (GLP-1) agonist semaglutide. Another preexisting trial supported by RECOVER-TLC, testing the immunomodulating drug baricitinib, is already enrolling.
RECOVER-TLC leaders and other staff from the National Institute for Allergy and Infectious Diseases (NIAID) and Foundation for the National Institutes of Health (FNIH), which jointly run the trials initiative, shared this prospective timeline along with other updates at a webinar on January 23. The webinar itself was delayed due to the government shutdown in the fall; it was originally scheduled for October 2025.
NIAID staff repeatedly emphasized that input from the Long COVID community has been crucial to developing the trials program, at Friday’s webinar as well as prior RECOVER-TLC events, such as the initiative’s research meetings in September 2024 and 2025. “Our output is better because of the community input,” said Joseph Breen, a program officer at NIAID who helps lead RECOVER-TLC.
But one key demand from community members has been speed, as the larger RECOVER program took more than two years to even announce clinical trials. RECOVER received $1.1 billion in initial funding from Congress in late 2020, followed by additional funds from the NIH now totalling about $1.8 billion. Much of that funding went toward observational studies.
“As someone involved in Long COVID clinical trials, both as a participant and in clinical trial design and operations, I understand that it does take time to plan and execute rigorous, safe, impactful trials,” said Ezra Spier, a Long COVID patient-advocate and creator of the site Long COVID Studies, which tracks clinical trials, in a statement to The Sick Times.
“But given the significant budget of the RECOVER-TLC program, and the promise of urgency at the outset of the program, I am disappointed. RECOVER-TLC was supposed to correct the mistakes of RECOVER 1.0 — at this point it really feels like more of the same.”
Given the significant budget of the RECOVER-TLC program, and the promise of urgency at the outset of the program, I am disappointed. RECOVER-TLC was supposed to correct the mistakes of RECOVER 1.0 — at this point it really feels like more of the same
Ezra Spier, Long COVID patient-advocate
At Friday’s webinar, speakers also reviewed the initiative’s lengthy and ongoing process for selecting potential Long COVID treatments to study. This included submissions from people with Long COVID, researchers, and other community members — nearly 600 potential treatments to date — followed by discussion in working groups. Breen noted that many working group members were community members who submitted treatments or applied to serve RECOVER-TLC, but did not share more specific details about how the initiative’s leaders selected people from those applicants.
The initiative’s portal for prospective treatments remains open, and staff are reviewing submissions on a rolling basis, said FNIH project manager Lizzie Geerling. While RECOVER-TLC has selected four treatments for its initial round of trials, the initiative may later support more studies, Breen said during the webinar, echoing his comments to The Sick Times in September.
RECOVER-TLC has not yet shared specific details about the budgets for these trials, despite questions from advocates. At Friday’s webinar, Breen said these budgets will become clearer once trial sites are determined.
Of those four trials, the baricitinib study, also called REVERSE-LC, is furthest along. REVERSE-LC had already started enrolling participants when RECOVER-TLC announced in September that it would provide the preexisting trial with additional funding, enabling the study to add more sites across the U.S. NIAID staff now anticipate 17 sites, up from the study’s original four.
RECOVER-TLC is also launching three new trials. One will test low-dose naltrexone (LDN), small amounts of an opiod addiction drug that some people with Long COVID and myalgic encephalomyelitis have used off-label. Unlike other research into LDN, the NIH trial will specifically test this treatment in children and young adults.
The LDN trial recently went through a short public comment period, in which community members could review and offer feedback on a draft of the trial’s protocol. RECOVER-TLC’s LDN protocol working group is now discussing that feedback and updating the draft, while reviewing potential trial sites, said NIAID medical officer Kay Tomashek.
When asked about when enrollment will start for the LDN trial, Tomashek said, “I wish I had a date for you but I do not.” She then added that enrollment may begin in the summer.
Another new trial will test the GLP-1 agonist drug semaglutide (also known as Ozempic and Wegovy), which researchers hypothesize could address inflammation in Long COVID. At Friday’s webinar, NIAID medical officer Agam Rao said this trial will be “complementary” to another GLP-1 clinical trial at Scripps Research, which is testing the drug tirzepatide (Zepbound).
Semaglutide is only a GLP-1 agonist, while tirzepatide is a dual agonist with a glucose-dependent insulinotropic polypeptide component as well as GLP-1 component, Rao said. Comparing results from both trials “will give us a sense of whether the GLP component alone is beneficial,” Rao said. Scripps’ trial is also fully remote, and recruited quickly. It has completed enrollment, with 1,000 participants recruited in less than two months.
The GLP-1 protocol working group is currently meeting twice a week to discuss the trial’s design, Rao said. She added, “Our goal is for the synopsis to be available for public comment sometime in the spring, and then for the study to actually be ready for enrollment, perhaps late summer.”
NIAID staff did not share a prospective timeline for RECOVER-TLC’s final trial, which will test the stellate ganglion block procedure. Breen described this study as a “Phase 2, randomized, blinded, sham-controlled trial” comparing SGBs against a similar “sham” procedure; while patients will be blinded, healthcare providers administering treatments will not, as the nature of this procedure makes double-blinding difficult.
RECOVER-TLC staff plan to share further updates at the initiative’s next webinar, currently planned for March 2026.
Miles W. Griffis contributed reporting.
Betsy Ladyzhets, co-founder and managing editor at The Sick Times, will continue covering NIH RECOVER. Send her tips at betsy@thesicktimes.org or reach out on Signal.
Editor’s note: Julia Moore Vogel, the principal investigator of Scripps Research’s tirzepatide trial, is also an advisor to The Sick Times.
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