Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO): a Phase 2 Randomised Control Trial (EViSCO)
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|ClinicalTrials.gov Identifier: NCT03699904|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD EBV||Drug: Valaciclovir Drug: Placebo capsules (containing Avicel blend)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel assignment.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This will be randomised, double-blind trial with matching placebo.|
|Official Title:||A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Epstein-Barr Virus Suppression in Chronic Obstructive Pulmonary Disease (EViSCO).|
|Actual Study Start Date :||October 11, 2018|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Experimental: Active arm
Valaciclovir 1 gram orally three times daily for 8 weeks.
Participants will self-administer Valaciclovir 1 gram three times daily for 8 weeks.
Placebo Comparator: Placebo arm
Matching placebo capsules (containing Avicel blend). Two capsules 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.
- Incidence of Serious Adverse Reactions (SARS) [ Time Frame: Up to 28 days after completion of the study drug ]The primary outcome measure will be drug safety of valaciclovir (1 gram three times daily for 8 weeks) as defined by the incidence of Serious Adverse Reactions (SARs).
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: Change from baseline to 8 weeks ]Lung function measured by spirometry, the principal component will be the change in FEV1 from baseline to week 8.
- Drug tolerability as measured by the proportion of tablets self-administered. [ Time Frame: 8 weeks ]Drug tolerability will be measured by total number of tablets self-administered as a proportion of total number of tablets supplied.
- COPD assessment test (CAT) [ Time Frame: Change from baseline to 8 weeks ]This instrument is a disease specific questionnaire that can quantify the impact of COPD on the patient's health. The CAT has a scoring range of 0-40. Higher scores indicate more severe impact of COPD.
- EQ-5D-5L health status questionnaire [ Time Frame: Change from baseline to 8 weeks ]The EQ-5D-5L is a standardised questionnaire designed to measure health status (quality of life) in patients. The EQ-5D-5L comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension may be score from one to five enabling the description of 3125 different health states.
- EBV viral load [ Time Frame: Change from baseline to 8 weeks. ]Epstein-Barr virus (EBV) load in the sputum of subjects with COPD will be an exploratory efficacy outcome measured using quantitative polymerase chain reaction (PCR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699904
|Contact: Joe Kidney, MB, MDfirstname.lastname@example.org|
|Contact: Dermot Linden, MBChBemail@example.com|
|Principal Investigator:||Joe Kidney, MB, MD||Belfast Health and Social Care Trust|