Paxlovid for Long COVID

(RECOVER-VITAL Trial)

No longer recruiting at 3 trial locations

Overseen By Barrie Harper, BSMT (ASCP) PMP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kanecia Obie Zimmerman

Must not be taking: CYP3A drugs, CYP3A inducers

Disqualifiers: Pregnancy, Breastfeeding, Low eGFR, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 weeks

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. ^{1 2 3 4 5}

Why 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. ^{2 4 6 7 8}

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

See NCT NCT05595369 for RECOVER-VITAL: Platform Protocol level

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Paxlovid or placebo for 15 to 25 days

3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paxlovid

Trial Overview The study tests Paxlovid at two different dosing durations (15 days and 25 days) against a control group to see if it helps with Long COVID symptoms. It's double-blind, meaning neither doctors nor patients know who gets what treatment, ensuring unbiased results.

How Is the Trial Designed?

Group I: Paxlovid 25 day dosing Experimental Treatment 1 Intervention

Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days

Group II: Paxlovid 15 day dosing Experimental Treatment 1 Intervention

Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 15 days then ritonavir 100mg plus nirmatrelvir-matching placebo x 10 days

Group III: Control Placebo Group 1 Intervention

ritonavir 100mg plus nirmatrelvir-matching placebo bid x 25 days

Paxlovid is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

Approved in United States as Paxlovid for:

• COVID-19

Approved in European Union as Paxlovid for:

• COVID-19

Approved in Canada as Paxlovid for:

• COVID-19

Approved in Japan as Paxlovid for:

• COVID-19

Approved in Switzerland as Paxlovid for:

• COVID-19

Who Is Running the Clinical Trial?

Kanecia Obie Zimmerman

Lead Sponsor

Trials

9

Recruited

3,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38848477/

The STOP-PASC Randomized Clinical Trial - PubMed - NIH The results of this randomized clinical trial showed that a 15-day course of NMV/r in a population of patients with PASC was generally safe but did not ...

2. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00073-8/fulltext

a double-blind, randomised, placebo-controlled, phase 2, ... Post-COVID-19 condition, also known as long COVID or post-acute sequelae of SARS-CoV-2 infection, affects approximately 7–10% of patients with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05852873

PAxlovid loNg cOvid-19 pRevention triAl With recruitMent ... Aims and objectives: The study hypothesis is that antiviral treatment for acute Covid can prevent occurrence of persisting symptoms at 3 months and beyond. The ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37185834/

Efficacy of nirmatrelvir and ritonavir for post-acute COVID ... The effect of nirmatrelvir plus ritonavir (NMV-r) on post-acute COVID-19 sequelae beyond 3 months of SARS-CoV-2 infection remains unknown.

5. academic.oup.com academic.oup.com/ofid/article/12/8/ofaf449/8221041

Patient-Reported Outcomes of Nirmatrelvir Treatment for High ... We describe patient-reported outcomes with NMV/r in nonhospitalized adults with COVID-19 at high risk of severe disease. Methods. In a phase 2/3 ...

6. nature.com nature.com/articles/s43856-024-00668-8

Impact of extended-course oral nirmatrelvir/ritonavir in ... Our results suggest that extended courses of nirmatrelvir/ritonavir could be beneficial for some people with Long COVID.

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2819901

Nirmatrelvir-Ritonavir and Symptoms in Adults With ... A 15-day course of nirmatrelvir-ritonavir in a mostly vaccinated study cohort was generally safe, but did not show significant benefit in improving fatigue, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05576662

NCT05576662 | Paxlovid for Treatment of Long Covid The purpose of this study is to compare whether being treated with nirmatrelvir plus ritonavir for 15 days works better than being treated with placebo plus ...