What is the mechanism of action of this treatment?

The most common treatments for Long COVID Syndrome include antivirals and anti-inflammatory agents. Antivirals inhibit the replication of the virus, reducing the viral load and addressing persistent viral infection, a suspected cause of prolonged symptoms. Anti-inflammatory agents reduce chronic inflammation caused by an overactive immune response, potentially alleviating symptoms like fatigue, pain, and cognitive issues. These treatments are crucial as they target the underlying causes of Long COVID symptoms, offering patients a pathway to recovery.

What side effects are associated with this type of intervention?

Common treatments for Long COVID Syndrome, particularly antivirals and anti-inflammatory agents, can have a range of side effects. Antivirals may cause gastrointestinal issues such as nausea, vomiting, and diarrhea, as well as headaches and fatigue. Anti-inflammatory agents, including corticosteroids, can lead to side effects like mood swings, increased blood sugar levels, and a higher risk of infections. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Long COVID Syndrome. However, ongoing research and clinical trials are exploring the use of antivirals and anti-inflammatory agents to address persistent viral infection and chronic inflammation associated with Long COVID. These studies aim to determine the efficacy of such treatments in improving symptoms by achieving viral clearance and reducing inflammation.

What other types of research exist?

Promising novel alternatives for Long COVID Syndrome patients include low-dose oral interferon alpha, microdose DNA, low-dose thimerosal, and phytocannabinoids. These agents aim to modulate the immune response and reduce inflammation, potentially alleviating symptoms and severity of Long COVID.

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Antiviral

Paxlovid for Long COVID (RECOVER-VITAL Trial)

Phase 2

Waitlist Available

Led By Kanecia O Zimmerman, MD PhD

Research Sponsored by Kanecia Obie Zimmerman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Summary

This trial is testing various antiviral and other treatments to help people with long-term COVID-19 symptoms. The goal is to see if these treatments can get rid of any remaining virus, stop it from becoming active again, or calm down the immune system. Participants will receive different treatments to find out which works best.

Who is the study for?

This trial is for adults who've had COVID-19 and are now experiencing Long COVID symptoms persisting for at least 12 weeks. Participants should be able to give consent, complete surveys, and attend follow-up visits. Those with active SARS-CoV-2 infection within the last 4 weeks, severe anemia, moderate/severe immunocompromise, or known allergies to study drugs cannot join.

What is being tested?

The RECOVER-VITAL trial is testing Paxlovid's effectiveness in treating Long COVID symptoms over two different durations: a 25-day course and a shorter 15-day course. A control group receives a placebo. The study aims to see if antivirals can clear lingering virus or reduce inflammation that might cause Long COVID.

What are the potential side effects?

Paxlovid may cause side effects like altered taste, diarrhea, high blood pressure, muscle aches. It could also interact with other medications leading to increased side effects from those medicines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total number of participants enrolled in each Appendix

Secondary study objectives

Adherence in intervention versus control groups as measured by number of missed doses

Dysautonomia

Syndrome

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: Paxlovid 25 day dosingExperimental Treatment1 Intervention

Drug: Paxlovid 25 day dosing Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days See NCT05965726 (Paxlovid Sub-study)

Group II: Experimental: Paxlovid 15 day dosingExperimental Treatment1 Intervention

Drug: Paxlovid 15 day Dosing Paxlovid (nirmatrelvir 300mg and ritonavir 100mg) bid x 15 days then ritonavir 100mg bid plus nirmatrelvir matching placebo bid x 10 days See NCT05965726 (Paxlovid Sub-study)

Group III: Placebo Comparator: ControlPlacebo Group1 Intervention

Drug: Control ritonavir 100mg taken bid plus nirmatrelvir matching placebo bid bid x 25 days See NCT05965726 (Paxlovid Sub-study)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Long COVID Syndrome include antivirals and anti-inflammatory agents. Antivirals inhibit the replication of the virus, reducing the viral load and addressing persistent viral infection, a suspected cause of prolonged symptoms. Anti-inflammatory agents reduce chronic inflammation caused by an overactive immune response, potentially alleviating symptoms like fatigue, pain, and cognitive issues. These treatments are crucial as they target the underlying causes of Long COVID symptoms, offering patients a pathway to recovery.