Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised Control Trial
NCT03699904 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2020-09-30
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.
Conditions
- COPD
- EBV
Interventions
- DRUG
-
Valaciclovir
Participants will self-administer Valaciclovir 1 gram three times daily for 8 weeks.
- DRUG
-
Placebo capsules (containing Avicel blend)
Participants will self-administer two matching placebo capsules (containing Avicel blend) three times daily for 8 weeks.
Sponsors & Collaborators
-
Northern Ireland Clinical Trials Unit
collaborator OTHER -
Queen's University, Belfast
collaborator OTHER -
Belfast Health and Social Care Trust
lead OTHER
Principal Investigators
-
Joe Kidney, MB, MD · Belfast Health and Social Care Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-11
- Primary Completion
- 2020-05-07
- Completion
- 2020-07-01
Countries
- United Kingdom
Study Locations
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