RECOVER-TLC Updates

What is RECOVER-TLC?
RECOVER-TLC is a new NIH clinical trials program, led by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the FNIH. The full name of the program is Researching COVID to Enhance Recovery-Treating Long COVID. RECOVER-TLC will apply lessons learned from RECOVER, an NIH program launched in 2021.

What are the goals of the RECOVER-TLC Initiative?
RECOVER-TLC is working to:

• Identify safe and effective Long COVID interventions that can be delivered quickly to healthcare providers
• Build on previous research, including ongoing RECOVER cohorts, pathobiology studies, and clinical trials
• Launch clinical trials with transparent engagement from scientists and people with lived experience
• Promote data-sharing with scientific communities, the Long COVID community, and the public

What is the difference between RECOVER and RECOVER-TLC?
RECOVER (Researching COVID to Enhance Recovery), was launched in 2021 to study and treat Long COVID. To date, over 90,000 adults and children have participated in RECOVER through observational studies, five master protocol clinical trials, and extensive reviews of electronic medical records. RECOVER has enabled researchers to learn more about Long COVID-associated genetic alterations, comorbidities that affect symptom severity, alterations in immune function, and duration of viral presence within various tissues.

RECOVER-TLC  is the next iteration of RECOVER. Building on progress and lessons learned over the past four years, RECOVER-TLC aims to identify promising therapeutics and biologics by launching the next wave of Long COVID clinical trials.

How can I find out which therapeutic agents are being considered for clinical trials – and submit my own ideas?
RECOVER-TLC created an online portal where anyone in the Long COVID community – patients, caregivers, scientists, etc. – can submit potential Long COVID therapeutics and biologics. Submissions sent to the portal are reviewed biweekly. To date, over 530 submissions have been received, and the portal remains open. View our RECOVER-TLC Therapeutics page to see a list of all submitted agents.

We invite you to submit additional therapeutics and biologics that could have potential in treating Long COVID to the online portal.

How are agents evaluated to determine their potential for clinical trials?
The agent scoring system for RECOVER-TLC is modeled after the procedures used by Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership formed to identify and prioritize top candidates for treating or preventing acute SARS-CoV-2infections. Agents submitted to the portal are classified into groups based on their mechanism of action:

• Drug (further subdivided into antiviral, immunomodulatory, cardiovascular, metabolic, or neurologic)
• Complementary and integrative health
• Manual and physical therapies
• Nutrition and diet
• Devices

Working groups have been formed for each of these agent classes. These working groups are comprised of subject matter experts, including people with lived experience. Each agent is scored by multiple working group members based on specific criteria, including:

• Rationale for treating Long COVID
• Safety
• Potential for drug-drug interactions
• Ability to be tested in a variety of populations, including children and pregnant or lactating women
• Availability and scalability

The scores an agent receives are averaged across reviewers. Then the working group meets so reviewers can highlight specific points and prioritize the top candidates for treating Long COVID. Recommendations are forwarded to the Scientific Oversight Committee for additional assessment.

Get a more detailed description of the Long COVID agent scoring criteria (PDF).

How often are agents reviewed?
Agents are reviewed on a rolling basis by the appropriate working group (i.e., an anti-inflammatory agent would be reviewed by the Immunomodulatory Working Group).

Will I be notified of the outcome if I submitted an agent for consideration?
Yes, you will receive an email from RECOVER-TLC. We will let you know if the agent will move forward in the review process, or if it is being deferred in favor of other agents that better meet the criteria defined for clinical trial evaluation.

Does RECOVER-TLC plan to study biomarkers for Long COVID?
RECOVER-TLC’s primary focus is to rapidly, collaboratively, and transparently advance treatments for Long COVID. This includes identifying promising therapeutics and biologics and launching clinical trials to test these interventions. RECOVER recently issued pathobiology awards to researchers investigating the biological processes underlying Long COVID, with several funded studies incorporating biomarker research. Learn more about the funded studies.

We recognize that while diagnostic biomarker development is not a focus of RECOVER-TLC, predictive biomarkers could have useful applications in clinical trials. Ihttps://recovercovid.org/pathobiologyf you have suggestions for biomarkers, you are welcome to submit them through the RECOVER-TLC Request for Information online form.

Who is involved with RECOVER-TLC?
RECOVER-TLC is led by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the National Heart, Lung, and Blood Institute (NHLBI); and the National Institute of Neurological Diseases and Stroke (NINDS). These partnerships are facilitated by the FNIH. RECOVER-TLC also collaborates with researchers from industry, government, and academia, as well as people with lived experience. View our RECOVER-TLC Therapeutics page to view a list of individuals serving on prioritization working groups within RECOVER-TLC.

If I want to be involved with RECOVER-TLC, who do I reach out to?
If you’re interested in volunteering to serve on a working group, you can submit your contact information through the RECOVER-TLC Request for Information online form.

How can I stay up-to-date on RECOVER-TLC happenings?
We encourage you to sign up for the RECOVER-TLC newsletter to stay updated on our progress. (Be sure to select the “RECOVER-TLC Newsletter” option.) Additionally, RECOVER-TLC hosts bimonthly webinars for the public and research community. View webinar resources, including previous recordings and upcoming dates.

If I have any additional questions, who do I contact?
Please reach out to the RECOVER-TLC team at [email protected].