Female patients diagnosed with long COVID exhibited clinically and statistically significant improvements in multiple long COVID symptoms when treated open-label with a combination of valacyclovir and celecoxib in an exploratory, proof of concept study.

Top line data from the study, initiated by Virios Therapeutics, shows patients experienced improvements in fatigue, pain, and symptoms of autonomic dysfunction and general well-being related to long COVID, otherwise known as post-acute sequelae of COVID-19 infection (PASC), when treated for 14 weeks, as compared to a control cohort of female long COVID patients matched by age, gender, and length of illness and treated with routine care. 

The statistically significant improvements in PASC symptoms and general health status were particularly encouraging given that the mean duration of long COVID illness was two years for both the treated and control cohort prior to enrollment in this trial, according to a release from Virios.

Based on the data, the company plans to meet with the US Food and Drug Administration in the second half of 2023 to discuss opening an investigational new drug application to formally assess treatment of symptoms associated with PASC using a fixed dose combination of valacyclovir and celecoxib.

“Given the lack of available treatments to improve care for patients suffering from long COVID symptoms, these encouraging results warrant progressing this unique combination treatment into advanced development for post-viral syndromes, including long COVID,” says R. Michael Gendreau, MD, PhD, chief medical officer of Virios Therapeutics, in a release. “We look forward to engaging the Food and Drug Administration to discuss progressing this novel treatment option into active phase 2 clinical development.”

Key Highlights

  • Female patients diagnosed with long COVID exhibited clinically and statistically significant improvements when comparing both within the valacyclovir and celecoxib cohort and between study cohorts in:
    • fatigue as measured with both the PROMIS fatigue instrument and a numeric rating scale for fatigue,
    • pain as measured by a numeric rating scale for pain,
    • and in autonomic dysfunction symptoms as measured using the Orthostatic Intolerance Questionnaire.  
  • Two different scales for Patient’s Global Impression of Change documented improvement in overall health when treated with open-label valacyclovir and celecoxib twice daily for 14 weeks.
  • Treatment with valacyclovir and celecoxib was generally well tolerated, with an observed safety profile consistent with the known safety profiles of valacyclovir and celecoxib. There were no serious adverse events observed in this study, and only one treated patient discontinued treatment due to adverse events, possibly related to valacyclovir and celecoxib treatment. Among those patients receiving valacyclovir and celecoxib, nausea was the most common adverse event. The most common adverse events in the routine care group were headaches and muscle pain.

This single-center, investigator-initiated study was conducted at the Bateman Horne Center with an unrestricted investigational grant. 

“Improvements in long COVID patients’ related fatigue, autonomic function, and overall patient health status suggest the potential for a combination of valacyclovir and celecoxib as a new treatment option for COVID-infected patients whose symptoms persist for months, if not years, past their recovery from the initial COVID illness,” says Lucinda Bateman, MD, founder and medical director of the Bateman Horne Center and the study’s principal investigator, in a release.

Prevalence estimates suggest as many as 65 million people worldwide have long COVID sequelae, including varying degrees of fatigue, cognitive problems, headache, sleep disruption, myalgias, arthralgias, post-exertional malaise, and autonomic dysfunction/orthostatic intolerance.