Open USA: Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms [LC] (REVERSE-LC)

forestglip

forestglip

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REVERSE LC is a study to see if an FDA-approved drug called Baricitinib (ber-uh-sit-uh-nib), which is already used to treat COVID, can help improve thinking and memory problems and reduce fatigue for people who have Long COVID.

Who Can Participate?
Adults 18 and older who have had thinking and memory problems for at least 6 months after a COVID-19 infection

Screening and Enrollment
To make sure this is the right study for you, we’ll ask you to complete some questionnaires, take a few tests, and complete some bloodwork.
The questionnaires, tests, and bloodwork will be completed over 1-2 in-person visits to enroll into the study.

Study Participation
After confirming that this is the right study for you, we’ll send you home with study pills to take every day for 6 months. While you’re taking the study pills, you’ll be asked to come into your study site for bloodwork once a month for 6 months. At 1 month, 3 months, and 6 months you’ll also be asked to complete some questionnaires and tests during your visit.

After 6 months, you’ll stop taking the study pills. This doesn’t mean your time in the study is over though. For 6 more months, you’ll fill out monthly surveys in an app on your phone.

Finishing the Study
12 months after you start the study, you’ll be asked to come in for one last in-person study visit. At this visit you’ll do the same questionnaires, tests, and bloodwork that you did on your first visit.

Enrollment is limited to eligible people living in North America. Enrolling sites are limited by how much they are able to reimburse participants for travel costs. The study team at whichever enrolling site is most convenient for you will have more information.

Study sites
  1. University of California San Francisco, San Francisco, California
  2. University of Minnesota, Minneapolis, Minnesota
  3. Vanderbilt University Medical Center, Nashville, Tennessee
  4. Emory University, Atlanta, Georgia
  5. University of Pennsylvania, Philadelphia, Pennsylvania
  6. Yale University, New Haven, Connecticut
ReversingLongCOVID.org

ClinicalTrials.gov
 
Some news from the RECOVER website (recoverid.org):

recovercovid.org

RECOVER-TLC opens expanded enrollment in REVERSE-LC clinical trial

Researchers at 17 study sites across the US will test a possible treatment to help improve thinking and memory problems and reduce fatigue for people who have Long COVID.
recovercovid.org recovercovid.org

RECOVER-TLC has expanded the ongoing REVERSE-LC study to add 11 new trial sites, bringing the total to 17 sites nationwide.

Seven of these study sites are actively screening individuals with Long COVID to see if they are eligible to participate.

With the addition of these new sites, REVERSE-LC has also increased its enrollment goal to 550 participants.
Click to expand...
 
People who know things about clinical trials: does them expanding REVERSE-LC imply anything (positive) about how the trial is going? (I've heard of RCTs being ended early due to serious side effects, so I guess that's not happening here at least?)
 
ScoutB said:
People who know things about clinical trials: does them expanding REVERSE-LC imply anything (positive) about how the trial is going? (I've heard of RCTs being ended early due to serious side effects, so I guess that's not happening here at least?)
Click to expand...
I wondered this back when RECOVER first announced they were funding it and it would therefore be expanded. Obviously it is a double blinded trial so you would hope they cant tell but I have heard one person who claimed to be a participant state that one of the doctors told them they were seeing good results and were hopeful for the drug (which is obviously unethical and bad scientific practice)
 


“i’m in a drug study for Baricitinib (REVERSE LC- clinical research trial) and it helps with this! [brain inflammation] it’s been life changing to not have my immune system at its own throat constantly. the study is still open for enrollment i believe!”

Again is this person sure she is not getting the placebo?
 
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Adding to the above, I started 4mg baricitinib around 100 days ago after 2.5 years of long covid. I was essentially homebound and on the verge of physical and mental collapse before Baricitinib.

My symptoms lean heavily neuro (more like psychosis than brain fog) and ANS. I don’t have PEM. My guess is that my symptoms are mediated by persistent cytokines (IL-6, etc.) altering central neurotransmitter levels. See Serotonin Reduction in Post-Acute Sequelae of Viral Infection; Wong.

I’m not cured, but the improvement (>50%) is dramatic and progressive (I keep improving). It’s the most effective treatment I’ve tried by a significant margin. I felt much worse during the first 3 weeks of baricitinib, then began markedly improving week by week.

Before Baricitinib, the only things that helped were Pemgarda (relief was uneven and not sustained) and 5ht2a agonists.
 
Sounds like it’s a helpful drug, but after googling and reading the side effects it’s pretty scary to me. I’m allergic to just about all meds, even antibiotics. This drug from drugs dot com appears to say that it could cause clots! I have hyperlipidemia, this would unalive me I’m afraid.

Is it normal to be allergic to all drugs with ME? I don’t know anyone else with it (hence signing up here) so I don’t know. Other than my opioids and medical mj I cannot even take an aspirin, something as simple as aloe vera has me vomiting. Really curious if this allergic to all drugs is ME or what?!
 
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