drugset / Trial / NCT03699904

Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised Control Trial

NCT03699904 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

COPD is a major public health problem and will shortly become the third most common cause of global mortality. There are currently no treatments that can meaningfully alter the progression of COPD or the time to death. Consequently novel therapeutic strategies for COPD are urgently required. This will be a randomised, double-blind, placebo-controlled, trial of Epstein-Barr virus suppression in COPD. Participants will be randomised to receive valaciclovir 1 gram three times daily for 8 weeks or matching placebo. The study will measure EBV suppression using quantitative PCR. Secondary outcomes will include Lung function quality of life and drug tolerability. The exploratory analysis will evaluate biomarkers of airway inflammation within the sputum and blood.

Timeline

Start
2018-10-11
Primary completion
2020-05-07
Completion
2020-07-01

Outcome

Met primary endpoint

Stopped (Enrollment): “In light of the evolving Covid19 pandemic ongoing study recruitment was felt to pose an unacceptable risk to patient safety.”

paper A greater number of participants in the valaciclovir group achieved EBV suppression (n = 36 [87.8%] vs n = 17 [42.5%]; P < .001). PMID 37011709 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Valaciclovir Unknown 1 g Oral