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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699904
Recruitment Status : Terminated (In light of the evolving Covid19 pandemic ongoing study recruitment was felt to pose an unacceptable risk to patient safety.)
First Posted : October 9, 2018
Last Update Posted : September 30, 2020
Sponsor:
Collaborators:
Northern Ireland Clinical Trials Unit
Queen's University, Belfast
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

Brief 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.

Condition or disease Intervention/treatment Phase
COPD EBV Drug: Valaciclovir Drug: Placebo capsules (containing Avicel blend) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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
Actual Primary Completion Date : May 7, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
Experimental: Active arm
Valaciclovir 1 gram orally three times daily for 8 weeks.
Drug: Valaciclovir
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.




Primary Outcome Measures :
  1. 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).

  2. EBV viral load [ Time Frame: Change from baseline to 8 weeks. ]
    The primary efficacy outcome is suppression of Epstein-Barr virus in the sputum measured using quantitative PCR at baseline and 8 weeks.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. COPD assessment test (CAT) score [ 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.

  2. 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 scored from one to five enabling the description of 3125 different health states.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age over 18 years.
  2. Clinical diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease criteria (FEV1/FVC <70%) with GOLD 2 and GOLD 3 airflow obstruction (FEV1 30-80% predicted) with significant symptoms.
  3. Presence of Epstein-Barr virus on sputum PCR analysis.

Exclusion Criteria:

  1. Respiratory failure (defined as long-term oxygen therapy).
  2. An acute exacerbation of COPD in the previous month (defined as an acute, sustained worsening of symptoms that is beyond normal day-to-day variations).
  3. A diagnosis of asthma.
  4. Patients with known hypersensitivity to valaciclovir or aciclovir.
  5. Patients unable to swallow study drug capsules.
  6. Established diffuse interstitial lung disease (e.g. Idiopathic Pulmonary Fibrosis).
  7. Established diagnosis of symptomatic bronchiectasis.
  8. Patients known to be pregnant or breastfeeding.
  9. Patients with an estimated creatinine clearance less than 50ml/minute.
  10. Known participation in investigational medicinal product trials within 30 days.
  11. Patients who do not adequately understand verbal or written information.
  12. Concomitant use of nephrotoxic medicinal products or medicines associated with altered renal tubular secretion. These include aminoglycosides, organoplatinum compounds, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus,tenofovir, cimetidine and probenecid. As iodinated contrast used in radiological examinations can be nephrotoxicity patients with planned radiological contrast studies will be deferred for a reasonable time until after their contrast.
  13. For the exploratory bronchoscopy sub-study patients will require adequate oxygen saturations, FEV1 >0.5 L and will not be performed while patients are taking aspirin or clopidogrel (BTS guidelines 2013).

Information from the National Library of Medicine

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


Locations
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United Kingdom
Belfast Health and Social Care Trust
Belfast, Down, United Kingdom, BT5 7GX
Sponsors and Collaborators
Belfast Health and Social Care Trust
Northern Ireland Clinical Trials Unit
Queen's University, Belfast
Investigators
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Principal Investigator: Joe Kidney, MB, MD Belfast Health and Social Care Trust
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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03699904    
Other Study ID Numbers: 14143JK-AS
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belfast Health and Social Care Trust:
COPD
EBV
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Valacyclovir
Antiviral Agents
Anti-Infective Agents