SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction (SHIELD)
Icahn School of Medicine at Mount Sinai
Summary
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 placebo (this does not contain the medications).
Description
This is an off-label, randomized, double-blind, active placebo-controlled, two-arm clinical trial of a combination of celecoxib, valacyclovir, and Paxlovid in adults with Long COVID. 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 primarily measured through blood and urine measures. Efficacy will be evaluated by measuring patient-reported outcomes.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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.…
Interventions
- DrugValacyclovir
one to two 750mg capsules taken orally in the morning and evening
- DrugCelecoxib
200mg capsules taken orally in the morning and evening
- DrugPaxlovid
one (100mg ritonavir tablet and two 150mg nirmatrelvir tablets) taken orally in the morning and evening
- DrugPlacebo
matching placebo capsules and tablets taken orally in the morning and evening
Location
- The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)New York, New York