Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
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
- Rhinovirus Infection
Eligibility
- Eligible Ages
- Between 40 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
to be assessed only at Randomization: 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. Exclusion Pregnant or nursing or expected to become pregnant during the study period. Experiencing a current/active or prior exacerbation within 2 months of the Screening Visit (these participants should be rescreened after the exacerbation has been resolved for two months). Participants with other primary causes of chronic airflow limitation: - Including but not limited to: asthma alone (COPD with asthmatic features is acceptable), CF, bronchiolitis obliterans, fibrosis such as TB, IPF, non-CF bronchiectasis with multi-lobe involvement or other major respiratory diagnosis (e.g., allergic bronchopulmonary aspergillosis), etc. Any disorder, for example, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric impairment that is not medically stable, or other major physical impairment that is not considered by the investigator medically stable/controlled. Participants with hepatitis B are excluded. Participants on a stable treatment for HIV can be permitted with permission from the medical monitor. Participants with hepatitis C should be treated and confirmed HCV RNA negative prior to enrollment. (Testing performed at the Screening Visit). In the Investigator's opinion, the participant has any clinically significant laboratory abnormality including an abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease. Presence of clinically significant out-of-range cardiac interval on the screening ECG including a QTcF > 450 msec (men) and a QTcF > 460 msec (women). Medications or other non-medicinal products that could be impacted by CYP3A4, CYP2C8, or CYP2C19 induction and have serious complications for the participant within the treatment period. Medications that are potent CYP2C8, CYP3A4 or CYP2C19 inducers that would reduce exposures of VPV. Medications that are potent CYP2C8, CYP3A4, or CYP2C19 inhibitors that would increase exposures of VPV. Medications that are substrates of MATE1, OAT3, P-gp, and BCRP for which elevated concentrations are associated with serious and/or life-threatening reactions. Use of either of the following treatments: - Chronic oral/systemic steroids >10 mg per day (inhaled corticosteroids are permitted). - Continuous oxygen via nasal cannula of >2 L/min at the time of Screening or during the Asymptomatic Phase. (Participants on continuous oxygen may have the rate increased during physical exercise/ exertion or to cover any situationally induced decompensation, so long as the participant will resume a continuous rate of ≤2 L/min thereafter). Participation in another investigational drug study within 5 half-lives prior to Screening and during the study is prohibited. This includes approved drugs being evaluated for a new indication. Observational studies are permitted. Participants who have taken VPV in another clinical trial.
Exclusion Criteria
to be assessed only at Randomization: It is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and/or oral steroids at the Day 1 Randomization Visit. On or within 7 days prior to randomization, there is another active diagnosed infection with viral or bacterial pathogens (i.e., urinary tract infection, cellulitis, etc.) that requires treatment.
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
| Arm | Description | Assigned 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. |
|
|
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. |
|
|
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 |
|
Recruiting Locations
Mobile, Alabama 36608
Velocity Clinical Research - Mobile
Tempe, Arizona 85281
AMR Clinical - Tempe
Inglewood, California 90301
310 Clinical Research, LLC
Newport Beach, California 92663
NewportNativeMD, Inc.
San Diego, California 92120
Apex Clinical Research
Bradenton, Florida 34209
Synergy Health
Miami Lakes, Florida 33014
VM Clintrials
Miami Lakes, Florida 33016
Medquest Translational Sciences
Tamarac, Florida 33321
Metropolitan Clinical Research Center
East Point, Georgia 30344
Covenant Critical Pulmonary Care
Snellville, Georgia 30078
Accelerated Clinical Trials, LLC
Naperville, Illinois 60540
Bioluminux Clinical Research Illinois
Valparaiso, Indiana 46383
Velocity Clinical Research - Valparaiso
Lexington, Kentucky 40509
AMR Clinical - Lexington
Lutherville, Maryland 21093
Patient First Clinical Trials (PFCTRIALS)
Dearborn, Michigan 48126
Verexa Health
Troy, Michigan 48085
Oakland Medical Research
Hamilton, New Jersey 08690
Bioluminux Clinical Research New Jersey
Binghamton, New York 13905
Velocity Clinical Research - Binghamton
Brooklyn, New York 11226
Brooklyn Clinical Research
Kings Mountain, North Carolina 28086
CRC Kings Mountain
Columbus, Ohio 43215
Remington-Davis, Inc.
Milford, Ohio 45150
Hometown Urgent Care - Milford
Edmond, Oklahoma 73013
Tekton Research
Medford, Oregon 97504
Velocity Clinical Research - Medford
DuBois, Pennsylvania 15801
Clinical Research Associates of Central PA, LLC l
Pittsburgh, Pennsylvania 15423
Preferred Primary Care Physicians - St. Clair
Anderson, South Carolina 29621
Velocity Clinical Research - Anderson
Rock Hill, South Carolina 29732
Clinical Research of Rock Hill
Spartanburg, South Carolina 29303
Velocity Clinical Research - Spartanburg
Union, South Carolina 29379
Velocity Clinical Research - Union
Dallas, Texas 75230
Zenos Clinical Research, LLC
Kingwood, Texas 77339
Activian Clinical Research
Lewisville, Texas 75057
Epic Clinical Research, LLC
More Details
- Status
- Recruiting
- Sponsor
- Altesa Biosciences, Inc.