This past summer, we completed an open-label, proof of concept trial using a combination of valacyclovir, the generic form of Valtrex, and celecoxib, the generic form of Celebrex to see if it improved symptoms in women sick with Long COVID. The combination of these drugs has two specific mechanisms of action that could inhibit herpesvirus reactivation and keep these viruses in a latent state or tamp down their replication. The valacyclovir works by inhibiting viral DNA polymerase, reducing viral DNA synthesis and replication. Celecoxib, a COX-2 inhibitor, has anti-herpesvirus activity by downregulating COX-2 which herpesviruses turn on and up-regulate to help with viral replication. We hypothesized that the combined usage of valacyclovir plus celecoxib would suppress tissue resident viruses and effectively manage the symptoms of Long COVID. The results were positive and showed statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction and general well-being related in the treatment group compared to women in the control group receiving standard of care.
To confirm these encouraging results, we designed the gold standard of clinical trials – a randomized double-blind placebo controlled trial – to test whether two different daily doses of valacyclovir and celecoxib is a safe and effective treatment of symptoms in women sick with Long COVID. This trial will enroll up to 60 women who have Long COVID symptoms. Since this is a randomized, double-blind, placebo control trial, the drug and placebo look identical and neither the participants nor BHC staff knows who is receiving drug or placebo. The participants are randomly assigned to either the treatment or placebo arm. BHC needs to recruit and screen at least 600 women with Long COVID to enroll and randomized 60 women to achieve our target enrollment. This trial enrolls only women to minimize the differences introduced by sex in this relatively small study.
We are on a roll! This trial received approval in October and since then 75 people have expressed, interest and about half meet eligibility criteria. So far, five women have been enrolled and three women have been randomized. We are just at the beginning and are excited by the tremendous interest and responses we have received so far. Our goal is to complete enrollment and randomize all 60 participants early in 2024 so that we can unblind and analyze the results by the summer.
If you are interested in participating, click here to help us determine if you eligible.
You can also email us at [email protected] or call (801) 532-8311.
Dr. Lucinda Bateman is the Principal Investigator of this trial. The Bateman Horne Center received a grant from Virios Therapeutics (https://www.virios.com/) to conduct this investigator-initiated trial.