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

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03699904 on ClinicalTrials.gov