RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Valacyclovir for Post-acute Sequelae of COVID-19

The purpose of this research study is to test if the combination of three drugs, valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adults compared to a dummy treatment (placebo) (this does not contain the medications).

Official registry: https://clinicaltrials.gov/study/NCT07597902 · Icahn School of Medicine at Mount Sinai · enrollment listed as 150

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Valacyclovir, Celecoxib, or Paxlovid. The registry lists allocation as randomized. The purpose of this research study is to test if the combination of three drugs, valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adults compared to a dummy treatment (placebo) (this does not contain the medications).

They plan to enroll about 150 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction (SHIELD)

Interventions: Valacyclovir, Celecoxib, Paxlovid, Placebo

Primary outcome (registry wording): EQ-5D-5L Visual Analogue Scale (VAS)

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
18-65 years of age at the time of study entry
Diagnosed with Long COVID
Individuals of child-bearing potential must have a negative serum pregnancy test at screening and agree to on-site urine pregnancy testing at all subsequent study visits
A urine drug screen performed at the Screening Visit must be negative for drugs of abuse such as methamphetamine, cocaine, phencyclidine (PCP), and non-disclosed amphetamines and opioids/opiates
Those with mild to moderate depression should be clinically stable for three months, without risk of suicidal ideation or behavior

Who the registry excludes

Breastfeeding, pregnant, or planning to become pregnant during the next six months
In the opinion of the Investigator, any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the individual's ability to participate in the study or potentially compromise their well-being while enrolled in the study
Currently meeting criteria for ME/CFS at the pre-screening or screening visit, or a prior confirmed diagnosis of ME/CFS within the last 5 years. This may be determined as part of the initial screening call or visit
Any anticipated need for surgery that in the opinion of the Principal Investigator or Sub-I might confound results or interfere with the participant's ability to comply with the protocol
Symptomatic and/or otherwise clinically significant cardiac disease
Acute non-COVID systemic infection (e.g., HIV, hepatitis) or other active viral or bacterial infection during the screening/washout period or at the Baseline visit
Currently receiving chronic systemic corticosteroids (\>5 mg prednisone daily, or equivalent)

Public study contact (from the registry)

David Putrino, PhD

212-241-7658

CoreResearch@mountsinai.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) — New York, New York (recruiting)

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FAQ about this NCT record

Is NCT07597902 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07597902?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07597902?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary