Celecoxib + Valacyclovir + Paxlovid for Post-COVID Syndrome
(SHIELD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of three drugs—valacyclovir (an antiviral medication), celecoxib (a nonsteroidal anti-inflammatory drug), and Paxlovid (an antiviral treatment)—to determine if they can reduce symptoms of Long COVID in adults. Participants will receive either the drug combination or a placebo (a pill with no active ingredients) over a 14-week period. Suitable candidates for this trial are adults diagnosed with Long COVID who have been experiencing its symptoms and are not currently using certain medications or having significant other health issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you do not take certain medications like chronic systemic corticosteroids, warfarin, and others listed in the exclusion criteria. If you are on these medications, you should not participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using valacyclovir, celecoxib, and Paxlovid together may help treat Long COVID symptoms. In past studies, these drugs have been used both together and separately, yielding positive results. Patients noticed improvements in their symptoms when taking valacyclovir and celecoxib. Adding Paxlovid for a short time seemed to enhance these effects.
The safety of these drugs is crucial. Paxlovid is already approved for treating COVID-19, indicating its well-established safety. Valacyclovir is commonly used for viral infections, and celecoxib is a regular pain reliever. These drugs have generally been well-tolerated in similar situations. While side effects can occur, studies have not found any major safety concerns with this combination. However, monitoring for any side effects during the trial remains important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Celecoxib, Valacyclovir, and Paxlovid for Post-COVID Syndrome because it targets the condition in a novel way. Unlike standard treatments that often focus on managing individual symptoms, this combination aims to address underlying viral persistence and inflammation, which may contribute to long-lasting symptoms. Celecoxib is an anti-inflammatory drug, Valacyclovir is an antiviral, and Paxlovid has shown effectiveness against COVID-19, making this treatment a comprehensive approach. By using these drugs together, the treatment has the potential to reduce symptoms more effectively and possibly faster than current options.
What evidence suggests that this trial's treatments could be effective for Long COVID?
Research has shown that a combination of celecoxib, valacyclovir, and Paxlovid may help treat Long COVID symptoms. In this trial, participants in the experimental arm will receive this combination therapy, which has improved issues like fatigue, brain fog, and nervous system problems affecting automatic body functions. Paxlovid alone has lowered the risk of Long COVID in people with certain health conditions. Additionally, using valacyclovir and celecoxib together has improved symptoms in past patients. This combination therapy could be a strong option for reducing Long COVID symptoms.12346
Who Is on the Research Team?
David Putrino, PhD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 who have been diagnosed with Long COVID. Participants must not be pregnant, must test negative for drug abuse, and any mild to moderate depression should be stable without suicidal risk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination of valacyclovir, celecoxib, and Paxlovid for 14 weeks, with adjustments in dosages during the trial
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Celecoxib
- Paxlovid
- Valacyclovir
Trial Overview
The study tests whether a combination of three drugs—valacyclovir, celecoxib, and Paxlovid—can reduce Long COVID symptoms compared to a placebo. Participants are randomly assigned to receive either the drug combo or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
For 14 weeks, receives valacyclovir and celecoxib initially, then addition of Paxlovid for 15 days while decreasing valacyclovir dose, and then returns to valacyclovir at the original dose later.
For 14 weeks, receives matched placebo capsules and tablets
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Citations
Patient-reported improvements from use of IMC-2 alone and ...
There are various reasons why a combination of celecoxib, valacyclovir, and Paxlovid is well-positioned as a therapy to address symptoms arising ...
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long ...
This study aims to evaluate the safety and efficacy of the combination of celecoxib, valacyclovir, and Paxlovid in adults with Long COVID (LC).
3.
biospace.com
biospace.com/press-releases/pridcor-therapeutics-reports-positive-long-covid-case-series-with-combination-antiviral-regimenPridCor Therapeutics Reports Positive Long COVID Case ...
This CAR appeared superior to the valacyclovir and celecoxib combination in improving self-reported fatigue, dysautonomia and brain fog in these ...
Celecoxib + Valacyclovir + Paxlovid for Post-COVID ...
The study tests whether a combination of three drugs—valacyclovir, celecoxib, and Paxlovid—can reduce Long COVID symptoms compared to a placebo.
5.
ctv.veeva.com
ctv.veeva.com/study/sars-cov-2-and-herpesvirus-inhibition-for-ending-long-covid-dysfunctionSARS-CoV-2 and Herpesvirus Inhibition for Ending Long ...
This study aims to evaluate the safety and efficacy of the combination of celecoxib, valacyclovir, and Paxlovid in adults with Long COVID (LC). Safety will be ...
6.
respiratory-therapy.com
respiratory-therapy.com/products-treatment/pharmaceuticals/clinical-trials/valacyclovir-celecoxib-combo-shows-promise-long-covid-symptom-relief/Valacyclovir, Celecoxib Combo Improves Long COVID ...
Patients with long COVID showed improvements in symptoms when treated with valacyclovir and celecoxib in an exploratory study.
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