Paxlovid for Long COVID
(RECOVER-VITAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines Paxlovid, a medication, to determine its effectiveness for individuals with Long COVID, characterized by long-term symptoms following COVID-19. Researchers aim to discover if varying durations of Paxlovid treatment can alleviate these symptoms by addressing persistent virus or chronic inflammation. Participants will receive either Paxlovid for 15 or 25 days, or a placebo, to compare outcomes. Individuals with ongoing COVID-19 symptoms who suspect they have Long COVID might be suitable candidates. As a Phase 2 trial, this research measures Paxlovid's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.
Do I need to stop my current medications for the trial?
You may need to stop certain medications if they are highly dependent on CYP3A for clearance or if they are potent CYP3A inducers. Check with the trial team to see if your medications are affected.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Paxlovid, a combination of nirmatrelvir and ritonavir, is generally safe for people. Studies have found that a 15-day treatment with Paxlovid for patients with long COVID (also known as PASC) was mostly well-tolerated, with most participants experiencing no serious side effects. While the treatment did not always significantly improve symptoms like tiredness, it usually did not cause harm.
These studies provide some reassurance about the safety of Paxlovid for those considering this treatment. However, the current trial is still gathering more data to confirm these findings.12345Why are researchers excited about this trial's treatment for Long COVID?
Researchers are excited about Paxlovid for Long COVID because it uses a unique combination of two antiviral components: nirmatrelvir and ritonavir. While most treatments for Long COVID focus on symptom management, Paxlovid directly targets the virus's ability to replicate, potentially addressing the root cause of lingering symptoms. The dual approach, with nirmatrelvir inhibiting a key viral enzyme and ritonavir boosting its effectiveness, offers a novel method that could significantly reduce the duration and severity of Long COVID. The different dosing regimens being tested may also provide flexibility in treatment duration, which could be tailored to patient needs.
What evidence suggests that Paxlovid might be an effective treatment for Long COVID?
Research has shown that Paxlovid, a combination of nirmatrelvir and ritonavir, effectively treats COVID-19, particularly in individuals at high risk of severe illness. However, less information exists about its effects on long COVID, also known as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). Some studies suggest that Paxlovid might improve symptoms by clearing the virus or reducing inflammation, but clear evidence about its long-term benefits for PASC is lacking. Although Paxlovid is generally safe, more research is needed to understand its impact on long COVID symptoms. This trial will investigate two dosing regimens of Paxlovid—15-day and 25-day dosing—to evaluate its potential benefits for long COVID. The researchers hypothesize that it could help if ongoing viral infection causes long COVID.24678
Are You a Good Fit for This Trial?
This trial is for individuals experiencing Long COVID symptoms. Participants should fit the broader criteria outlined in the master protocol (NCT05595369). Specific details on who can join are not provided here, but typically include those with a confirmed history of COVID-19 and ongoing health issues related to it.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Paxlovid or placebo for 15 to 25 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Paxlovid
Paxlovid is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:
- COVID-19
- COVID-19
- COVID-19
- COVID-19
- COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kanecia Obie Zimmerman
Lead Sponsor