Purpose

Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.

Condition

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Sign informed consent for study participation and medical records release (if needed). Male or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening. If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective form of contraception at the time of randomization until 30 days (females) or 90 days (males) after the last dose. Female participants may not use hormonal birth control as a sole method. Participants will be asked to commit to this criterion at screening even though it does not need to be implemented until treatment is received. Confirmed diagnosis of COPD, defined as chronic cough, sputum production, and/or dyspnea with airflow obstruction which is not fully reversible (that is, post bronchodilator FEV1/FVC ratio <0.70 and post bronchodilator FEV1 ≥20% and <80% of predicted normal value). History of AECOPD with at least 1 documented AECOPD within 1 year of Screening. AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several days, and requires at least one of the following for 2 days 1. Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation) 2. Use of oral or systemic steroids (Moderate Exacerbation), or 3. Use of Antibiotics (Moderate Exacerbation), or 4. Emergency room visit or hospitalization (Severe Exacerbation). CAT score ≥10 at screening. Able to comply with all study requirements, including the use of a mobile application to complete daily PROs, perform nasal swabs at home, and able to assess when they have cold symptoms. Interacts with people at least twice a week without a mask (e.g., grocery shopping, dinner with grandchildren, eating at a restaurant, going to the movies, etc.) or are living in a multigenerational home.

Exclusion Criteria

(At Randomization only): If on stable COPD maintenance therapy this should be stable for at least 2 months prior to randomization. Changes allowed with Sponsor approval (i.e., change within same class due to financial considerations and clinically stable). Clinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization. The presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test. To be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dosing Group 1 VPV 1000 mg
The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 1,000 mg VPV will be taken at home the following morning with food. The subsequent 1,000 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
  • Drug: VPV 1000 mg
    Vapendavir 1000 mg
    Other names:
    • Vapendavir
Experimental
Dosing Group 2 VPV 500 mg
The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 500 mg VPV will be taken at home the following morning with food. The subsequent 500 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
  • Drug: VPV 1000 mg
    Vapendavir 1000 mg
    Other names:
    • Vapendavir
  • Drug: VPV 500 mg
    Vapendavir 500 mg
    Other names:
    • Vapendaivr
Placebo Comparator
Dosing Group 3 Placebo
The first dose of placebo will be taken at the study site with food once the Day 1 visit is completed. The second dose of placebo will be taken at home the following morning with food. The subsequent placebo doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses
  • Other: Placebo
    Placebo

Recruiting Locations

AMR Clinical - Tempe
Tempe, Arizona 85281
Contact:
AMR Clinical - Tempe

NewportNativeMD, Inc.
Newport Beach, California 92663
Contact:
NewportNativeMD, Inc.

Apex Clinical Research
San Diego, California 92120
Contact:
Apex Clinical Research

VM Clintrials
Miami Lakes, Florida 33014
Contact:
VM Clintrials

Accelerated Clinical Trials, LLC
Snellville, Georgia 30078
Contact:
Accelerated Clinical Trials, LLC

Velocity Clinical Research - Valparaiso
Valparaiso, Indiana 46383
Contact:
Velocity Clinical Research - Valparaiso

Patient First Clinical Trials (PFCTRIALS)
Lutherville, Maryland 21093
Contact:
Patient First Clinical Trials (PFCTRIALS)

Brooklyn Clinical Research
Brooklyn, New York 11226
Contact:
Brooklyn Clinical Research

CRC Kings Mountain
Kings Mountain, North Carolina 28086
Contact:
CRC Kings Mountain

Remington-Davis, Inc.
Columbus, Ohio 43215
Contact:
Remington-Davis, Inc.

Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania 15801
Contact:
Clinical Research Associates of Central PA, LLC l

Preferred Primary Care Physicians - St. Clair
Pittsburgh, Pennsylvania 15423
Contact:
Preferred Primary Care Physicians - St. Clair

Velocity Clinical Research - Anderson
Anderson, South Carolina 29621
Contact:
Velocity Clinical Research - Anderson

Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
Contact:
Clinical Research of Rock Hill

More Details

Status
Recruiting
Sponsor
Altesa Biosciences, Inc.

Study Contact

Karen Fusaro
610-242-0903
kfusaro@altesa.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.