Protocol RECOVER Treatment Study: Paxlovid for long Covid

RedFox

RedFox

Senior Member (Voting Rights)
The RECOVER Initiative is doing a trial on Paxlovid for long Covid. Here's the listing on ClinicalTrials.gov:
SARS CoV-2 Viral Persistence Study (PASC) - Study of Long COVID-19 (PASC)

Highlights:
  • Double-blind multi-center trial in the US
  • 1700 participants
  • They'll take the drug for 15 days
  • Primary outcome measures will be based on PEM, cognitive function, and dysautonomia. (Patients with different symptom clusters will be included, and they'll complete the evaluations relevant to them. For example, a person with just PEM will do the PEM survey, and someone with cognitive and autonomic issues will do those two.)
  • Start expected January 2023, completion expected January 2024
This is the first RECOVER treatment trial we've seen.
 
My opinion:
I'm not sold on viral persistence, so my expectations are modest. But this trial is rigorous! It should be big enough to deliver definitive results. It might be the largest treatment trial on post-viral conditions ever. (PACE enrolled 641 for reference, barely a third as many.)

I'm sure there will be more RECOVER studies to come, and this gives us a good idea of how the rest will be conducted. Since they're using very targeted measures (e.g. asking about PEM), I have high confidence.
 
RedFox said:
My opinion:
I'm not sold on viral persistence, so my expectations are modest.
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My opinion: I'm not big on viral persistence, the kind you can usually find using the usual tests made to detect infection. However, I'm curious about RNA viral persistence, which may be different, but I don't know enough to provide a comment.

RedFox said:
But this trial is rigorous! It should be big enough to deliver definitive results. It might be the largest treatment trial on post-viral conditions ever. (PACE enrolled 641 for reference, barely a third as many.)
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Going by the number of participants, I'm hoping it's a good indicator of how well thought out looking at both viral persistence and inflammation is.
 
I wonder what their rationale is for control getting ritonavir which is itself an antiviral? This trial will tell us if Paxlovid works better than just ritonavir alone but it wont tell us if viral persistence is the cause if potentially ritonavir is effective, that I am really not sure about at all.

It also excludes completely prior ME/CFS patients even if they are also long hauling which makes the cohort nice and clean but I think its a sign of things to come from RECOVER that ME/CFS patients will be intentionally excluded. Its also going to be brutal for the control group since all symptom control drugs have to be stopped, control (maybe the entire study) will thus likely have a higher drop out rate as a result.
 
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BrightCandle said:
I wonder what their rationale is for control getting ritonavir which is itself an antiviral? This trial will tell us if Paxlovid works better than just ritonavir alone but it wont tell us if viral persistence is the cause if potentially ritonavir is effective, that I am really not sure about at all.
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The problem is that nirmatrelvir, the drug that stop the virus from reproducing, is broken down by the liver very quickly. The ritonavir just services to slow down metabolism of the drug by keeping that liver enzyme "busy." Purposely creating drug interactions like this has been heavily leveraged to treat HIV.

I think they're giving the placebo arm ritonavir so they can show it's the antiviral making the difference, not the drug to modify its metabolism. With science it's ideal to test one thing at a time.

BrightCandle said:
It also excludes completely prior ME/CFS patients even if they are also long hauling which makes the cohort nice and clean but I think its a sign of things to come from RECOVER that ME/CFS patients will be intentionally excluded.
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Understandable because that's what Congress provided funding for. There was a bill that'd provide something for ME/CFS; I believe I wrote one of my legislators about it, but it went nowhere.

BrightCandle said:
Its also going to be brutal for the control group since all symptom control drugs have to be stopped, control (maybe the entire study) will thus likely have a higher drop out rate as a result.
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Not sure if that will mean much. Likely, relatively few of these people have found a medication that helps them.
 
Merged thread

What is being studied?
RECOVER-VITAL is studying whether PAXLOVID (a combination of nirmatrelvir and ritonavir), an antiviral drug used to treat mild-to-moderate COVID infections, can be used to treat Long COVID. PAXLOVID works to stop the virus that causes COVID-19 from multiplying.

When a person is given PAXLOVID for an active COVID infection, they usually take the drug for 5 days. In this study, participants will take a study drug for up to 25 days.

What do we hope to learn?
Results from this study will help us learn if taking PAXLOVID for a longer period of time is safe and improves Long COVID symptoms. The research team will use a variety of assessments, including lab tests and participant surveys, to determine if the study drug helps people feel better by reducing their Long COVID symptoms.

After the study is complete and the data have been analyzed, we will share the overall study results on this website.

What happens during this study?
Participants will be assigned by chance to one of these groups:
- Paxlovid (nirmatrelvir + ritonavir) 25 days
- Paxlovid (nirmatrelvir + ritonavir) 15 days, placebo (ritonavir) 10 days
- Placebo (ritonavir) 25 days


Links:
- https://trials.recovercovid.org/vital
- https://clinicaltrials.gov/study/NCT05595369
 
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