[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640888":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":44,"locations":50,"responsibleParty":221,"collaborators":43,"id":223,"slug":224,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":225,"sex":231,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":43,"studyType":237,"phases":238,"briefSummary":240,"conditions":241,"keywords":43,"overallStatus":53,"whyStopped":43,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Altesa Biosciences, Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Dosing Group 1 VPV 1000 mg","EXPERIMENTAL","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.",[13],"Drug: VPV 1000 mg",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13,18],"Drug: VPV 500 mg",{"label":20,"type":21,"description":22,"interventionNames":23},"Dosing Group 3 Placebo","PLACEBO_COMPARATOR","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",[24],"Other: Placebo",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","VPV 1000 mg","Vapendavir 1000 mg",[9,15],[32],"Vapendavir",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"VPV 500 mg","Vapendavir 500 mg",[15],[38],"Vapendaivr",{"type":40,"name":41,"description":41,"armGroupLabels":42,"otherNames":43},"OTHER","Placebo",[20],null,[45],{"name":46,"role":47,"phone":48,"phoneExt":43,"email":49},"Karen Fusaro","CONTACT","610-242-0903","kfusaro@altesa.com",[51,67,79,90,102,114,126,138,150,162,174,187,198,210],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"AMR Clinical - Tempe","RECRUITING","Tempe","Arizona","85281","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-111.90931,33.41477,{"lat":63,"lon":62},[66],{"name":52,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":68,"status":53,"city":69,"state":70,"zip":71,"country":57,"countryCode":58,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"NewportNativeMD, Inc.","Newport Beach","California","92663",{"type":60,"coordinates":73},[74,75],-117.92895,33.61891,{"lat":75,"lon":74},[78],{"name":68,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":80,"status":53,"city":81,"state":70,"zip":82,"country":57,"countryCode":58,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Apex Clinical Research","San Diego","92120",{"type":60,"coordinates":84},[85,86],-117.16472,32.71571,{"lat":86,"lon":85},[89],{"name":80,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":91,"status":53,"city":92,"state":93,"zip":94,"country":57,"countryCode":58,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"VM Clintrials","Miami Lakes","Florida","33014",{"type":60,"coordinates":96},[97,98],-80.30866,25.90871,{"lat":98,"lon":97},[101],{"name":91,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":103,"status":53,"city":104,"state":105,"zip":106,"country":57,"countryCode":58,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Accelerated Clinical Trials, LLC","Snellville","Georgia","30078",{"type":60,"coordinates":108},[109,110],-84.01991,33.85733,{"lat":110,"lon":109},[113],{"name":103,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":115,"status":53,"city":116,"state":117,"zip":118,"country":57,"countryCode":58,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Velocity Clinical Research - Valparaiso","Valparaiso","Indiana","46383",{"type":60,"coordinates":120},[121,122],-87.06114,41.47309,{"lat":122,"lon":121},[125],{"name":115,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":127,"status":53,"city":128,"state":129,"zip":130,"country":57,"countryCode":58,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Patient First Clinical Trials (PFCTRIALS)","Lutherville","Maryland","21093",{"type":60,"coordinates":132},[133,134],-76.62608,39.42122,{"lat":134,"lon":133},[137],{"name":127,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":139,"status":53,"city":140,"state":141,"zip":142,"country":57,"countryCode":58,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Brooklyn Clinical Research","Brooklyn","New York","11226",{"type":60,"coordinates":144},[145,146],-73.94958,40.6501,{"lat":146,"lon":145},[149],{"name":139,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":151,"status":53,"city":152,"state":153,"zip":154,"country":57,"countryCode":58,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"CRC Kings Mountain","Kings Mountain","North Carolina","28086",{"type":60,"coordinates":156},[157,158],-81.34119,35.24513,{"lat":158,"lon":157},[161],{"name":151,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":163,"status":53,"city":164,"state":165,"zip":166,"country":57,"countryCode":58,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Remington-Davis, Inc.","Columbus","Ohio","43215",{"type":60,"coordinates":168},[169,170],-82.99879,39.96118,{"lat":170,"lon":169},[173],{"name":163,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":175,"status":53,"city":176,"state":177,"zip":178,"country":57,"countryCode":58,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Clinical Research Associates of Central PA, LLC","DuBois","Pennsylvania","15801",{"type":60,"coordinates":180},[181,182],-78.76003,41.11923,{"lat":182,"lon":181},[185],{"name":186,"role":47,"phone":43,"phoneExt":43,"email":43},"Clinical Research Associates of Central PA, LLC l",{"facility":188,"status":53,"city":189,"state":177,"zip":190,"country":57,"countryCode":58,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Preferred Primary Care Physicians - St. Clair","Pittsburgh","15423",{"type":60,"coordinates":192},[193,194],-79.99589,40.44062,{"lat":194,"lon":193},[197],{"name":188,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":199,"status":53,"city":200,"state":201,"zip":202,"country":57,"countryCode":58,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Velocity Clinical Research - Anderson","Anderson","South Carolina","29621",{"type":60,"coordinates":204},[205,206],-82.65013,34.50344,{"lat":206,"lon":205},[209],{"name":199,"role":47,"phone":43,"phoneExt":43,"email":43},{"facility":211,"status":53,"city":212,"state":201,"zip":213,"country":57,"countryCode":58,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Clinical Research of Rock Hill","Rock Hill","29732",{"type":60,"coordinates":215},[216,217],-81.02508,34.92487,{"lat":217,"lon":216},[220],{"name":211,"role":47,"phone":43,"phoneExt":43,"email":43},{"type":222,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100640888","phase-2-trial-comparing-the-safety-and-efficacy-of-two-different-oral-vpv-doses-with-placebo-as-treatment-for-rv-in-participants-with-copd-100640888",false,"NCT07610395","Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD","A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial Comparing the Safety and Efficacy of Two Different Oral Vapendavir (VPV) Doses With Placebo as Treatment for Rhinovirus (RV) in Participants With Chronic Obstructive Pulmonary Disease (COPD)","Cardinal COPD","Inclusion\n\nSign informed consent for study participation and medical records release (if needed).\n\nMale or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening.\n\nIf sexually active and\u002For 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. See Section 11.2 below.\n\nConfirmed diagnosis of COPD, defined as chronic cough, sputum production, and\u002For dyspnea with airflow obstruction which is not fully reversible (that is, post bronchodilator FEV1\u002FFVC ratio \\\u003C0.70 and post bronchodilator FEV1 ≥20% and \\\u003C80% of predicted normal value).\n\nHistory of AECOPD with at least 1 documented AECOPD within 1 year of Screening.\n\n* AECOPD is defined as an event characterized by dyspnea and\u002For cough and increased sputum purulence\u002Fchange in sputum color that worsens over several days, and requires at least one of the following for at least 2 days:\n* Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation)\n* Use of oral or systemic steroids (Moderate Exacerbation), or\n* Use of Antibiotics (Moderate Exacerbation), or\n* 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.\n\nInteracts 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.\n\nInclusion criteria to be assessed only at Randomization:\n\nIf 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).\n\nClinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization.\n\nThe presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test.\n\nTo be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB.\n\nExclusion\n\nPregnant or nursing or expected to become pregnant during the study period. Experiencing a current\u002Factive or prior exacerbation within 2 months of the Screening Visit (these participants should be rescreened after the exacerbation has been resolved for two months).\n\nParticipants with other primary causes of chronic airflow limitation:\n\n\\- 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.\n\nAny 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\u002Fcontrolled.\n\nParticipants 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).\n\nIn the Investigator's opinion, the participant has any clinically significant laboratory abnormality including an abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.\n\nPresence of clinically significant out-of-range cardiac interval on the screening ECG including a QTcF \\> 450 msec (men) and a QTcF \\> 460 msec (women).\n\nMedications 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.\n\nMedications that are potent CYP2C8, CYP3A4 or CYP2C19 inducers that would reduce exposures of VPV.\n\nMedications that are potent CYP2C8, CYP3A4, or CYP2C19 inhibitors that would increase exposures of VPV.\n\nMedications that are substrates of MATE1, OAT3, P-gp, and BCRP for which elevated concentrations are associated with serious and\u002For life-threatening reactions.\n\nUse of either of the following treatments:\n\n* Chronic oral\u002Fsystemic steroids \\>10 mg per day (inhaled corticosteroids are permitted).\n* Continuous oxygen via nasal cannula of \\>2 L\u002Fmin at the time of Screening or during the Asymptomatic Phase. (Participants on continuous oxygen may have the rate increased during physical exercise\u002F exertion or to cover any situationally induced decompensation, so long as the participant will resume a continuous rate of ≤2 L\u002Fmin thereafter).\n\nParticipation 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.\n\nParticipants who have taken VPV in another clinical trial.\n\nExclusion criteria to be assessed only at Randomization:\n\nIt is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and\u002For oral steroids at the Day 1 Randomization Visit.\n\nOn 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.","ALL","40 Years","85 Years",{"count":235,"type":236},180,"ESTIMATED","INTERVENTIONAL",[239],"PHASE2","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\u002For duration of respiratory symptoms associated with RV infections in patients with COPD.",[242],"Rhinovirus Infection","2026-06-22",{"date":245,"type":246},"2026-06-24","ACTUAL",{"date":248,"type":246},"2026-05-01",{"date":250,"type":236},"2027-11-15",{"name":5,"class":6},14]