Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06206720
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013535', 'term': 'Suspensions'}, {'id': 'C000722705', 'term': 'GS-621763'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events during the study', 'timeFrame': 'From baseline through study completion, up to Day 26', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Subject withdrawals due to Adverse Events', 'timeFrame': 'From baseline through study completion, up to Day 26', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Time to resolution of 6 clinical symptoms related to RSV infection', 'timeFrame': 'From baseline through study completion, up to Day 14', 'description': 'Time to resolution of 6 clinical symptoms related to RSV infection'}, {'measure': 'Time to resolution of individual clinical symptoms related to RSV infection', 'timeFrame': 'From baseline through study completion, up to Day 14', 'description': 'Time to resolution of individual clinical symptoms related to RSV infection'}, {'measure': 'Differences of the proportion of subjects with wheezing remission', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'Differences of the proportion of subjects with wheezing remission'}, {'measure': 'Differences of the proportion of subjects with wheezing resolution', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'Differences of the proportion of subjects with wheezing resolution'}, {'measure': 'Difference of the proportion of subjects with cough remission', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'Difference of the proportion of subjects with cough remission'}, {'measure': 'Difference of the proportion of subjects with cough resolution', 'timeFrame': 'From baseline up to Day2-7、Day14 and D26', 'description': 'Difference of the proportion of subjects with cough resolution'}, {'measure': 'Changes of bronchiolitis score', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The differences of change in the bronchiolitis score are to be evaluated between the Deuterium Hydrobromide for suspension and placebo arms after treatment. The total score is reported with a range from 0 to 12. The minimum and maximum values of 0 and 3 separately are defined for each scoring item. A decreasing value of the total score represents a clinical improvement. Subscales are not applicable in this scoring system.'}, {'measure': 'Proportions of subjects achieving symptom remission &disease remission', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'Symptom remission was defined as bronchiolitis score ≤1. Disease remission was defined as bronchiolitis score ≤1 and with no assisted ventilation.'}, {'measure': 'Time from first treatment to symptom remission &disease remission', 'timeFrame': 'From first treatment through study completion, up to Day 14', 'description': 'The time difference from the first treatment to the time subjects achieved symptom remission between the Deuterium Hydrobromide for suspension and placebo arms.\n\nThe time difference from the first treatment to the time subjects achieved disease remission between the Deuterium Hydrobromide for suspension and placebo arms.'}, {'measure': 'Differences of frequency of Intensive Care Unit (ICU) admission', 'timeFrame': 'From first treatment through study completion, up to Day 14', 'description': 'The differences of frequency of ICU admission between Deuterium Hydrobromide for suspension and placebo arms.'}, {'measure': 'Differences of length of ICU stay', 'timeFrame': 'From first treatment through study completion, up to Day 14', 'description': 'The differences of length of ICU stay between Deuterium Hydrobromide for suspension and placebo arms.'}, {'measure': 'Differences of frequency of assisting ventilation', 'timeFrame': 'From first treatment through study completion, up to Day 14', 'description': 'The frequency difference from the first treatment to the end of assisting ventilation therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.'}, {'measure': 'Differences in the duration of receiving oxygen therapy', 'timeFrame': 'From first treatment through study completion, up to Day 14', 'description': 'The duration difference from the first treatment to the end of receiving oxygen therapy in subjects between the Deuterium Hydrobromide for suspension and placebo arms.'}, {'measure': 'Changes of viral load', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The antiviral effects in infants hospitalized with RSV are to be determined by measuring the differences in viral load determined by RT-PCR between the Deuterium Hydrobromide for suspension and placebo arms after treatment.'}, {'measure': 'Changes of area under curve of viral load', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The antiviral effects are to be determined by measuring the differences in area under curve (AUC).'}, {'measure': 'Apparent total body clearance (CL/F)', 'timeFrame': 'From baseline up to Day2-7', 'description': 'Apparent clearance of of 116-N1.'}, {'measure': 'Area under the plasma concentration time curve from time zero to the last(AUC0-t)', 'timeFrame': 'From baseline up to Day2-7', 'description': 'Area under the plasma concentration time curve from time zero to the last of 116-N1.'}, {'measure': 'apparent volume of distribution(V)', 'timeFrame': 'From baseline up to Day2-7', 'description': 'Apparent volume of distribution during the terminal phase of 116-N1.'}], 'secondaryOutcomes': [{'measure': 'The correlation between viral load and the resolution time of 6 clinical signs related to RSV infection', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'Check if there is a positive correlation between viral load and the resolution time of 6 clinical signs'}, {'measure': 'The correlation between viral load and bronchiolitis score', 'timeFrame': 'From baseline up to Day2-7and Day14', 'description': 'Check if there is a positive correlation between changes in viral load and changes in bronchiolitis score.'}, {'measure': 'The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (clinical signs、change in bronchiolitis score from baseline) in subjects', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The effect of the duration of RSV infection onset to the first use of the investigational drug on the treatment efficacy (clinical signs、change in bronchiolitis score from baseline) in subjects.'}, {'measure': 'The difference in length of hospital stay', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The difference in length of hospital stay between the experimental drug group and the placebo group due to RSV infection related diseases.'}, {'measure': 'Proportions of subjects with viral load below LLOQ', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The proportion of subjects whose viral load values are below LLOQ (lower limit of quantitation) after treatment.'}, {'measure': 'The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and the resolution time of clinical signs', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and the resolution time of clinical signs'}, {'measure': 'The correlation between AUC0-t （ Area under the plasma concentration time curve from time zero to the last）and bronchiolitis score and RSV viral load (VL) in respiratory sample', 'timeFrame': 'From baseline up to Day2-7 and Day14', 'description': 'The correlation between AUC0-t（ Area under the plasma concentration time curve from time zero to the last） and bronchiolitis score and RSV viral load (VL) in respiratory sample.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus Infection']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, efficacy, pharmacokinetic (PK) characteristics and antiviral activity of different doses of Deuterium Hydrobromide for suspension in the treatment of respiratory syncytial virus infection in infants.', 'detailedDescription': 'This trial is a randomized, double-blind, placebo-controlled, dose-ascending trial, and the subjects are infants infected with RSV from 1 to 24 months.\n\nIt is estimated that 60 subjects will be included and divided into low-dose group (15 mg/kg，BID), middle-dose group (20 mg/kg,BID) and high-dose group (20 mg/kg,TID), with 20 cases in each group, and they will be randomly assigned to the experimental drug group and the placebo group according to the ratio of 3: 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female infants ≥1 month and ≤24 months；\n2. Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；\n3. Onset of RSV infection symptoms should be ≤ 5 days；\n4. Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；\n5. Patient must have a Wang Respiratory Score ≥ 5;\n6. Patient who are hospitalized or in emergency/outpatient department and are expected to be hospitalized;\n7. The parent/legal guardian must have provided written informed consent for the patient to participate.\n\nExclusion Criteria:\n\n1. Patients who are less than 12 months old and whose head circumference is not within the normal range corresponding to their age and gender at the time of screening;\n2. Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.\n3. Requires vasopressors or inotropic support at the time of enrollment;\n4. Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；\n5. Patients with hypercapnia (Except for patients who have recovered at the time of screening);\n6. Chronic or persistent feeding difficulties;\n7. Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product;\n8. Symptomatic because of inborn errors of metabolism;\n9. Bronchopulmonary dysplasia requiring assisted ventilationor with clinically significant congenital respiratory abnormalities, except for the result of RSV infection;\n10. Patients with congenital heart disease (CHD) with significant hemodynamic changes, except simple CHD (such as patent ductus arteriosus, atrial septal defect or ventricular septal defect without hemodynamic influence).\n11. Clinical evidence of hepatic decompensation\n12. Renal failure including renal anomalies likely to be associated with renal insufficiency;\n13. Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged \\<6 months);\n14. Suspected or known to have congenital acquired immunodeficiency;\n15. A history of epilepsy or seizures;\n16. A history of high allergies;\n17. Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrollment;\n18. Participation in an investigational drug or device study within 30 days prior to the date of screening;\n19. Failure to satisfy the investigator of fitness to participate for any other reason.'}, 'identificationModule': {'nctId': 'NCT06206720', 'briefTitle': 'A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vigonvita Life Sciences'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus.', 'orgStudyIdInfo': {'id': 'VV116-RSV-II/III-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deuremidevir Hydrobromide for Suspension', 'description': 'Deuremidevir Hydrobromide for Suspension will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.', 'interventionNames': ['Drug: Deuremidevir Hydrobromide for Suspension']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo will be orally administered at the dosing levels of 15 mg/kg BID, 20 mg/kg BID, or 20 mg/kg TID for five days according to the weight of patients.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Deuremidevir Hydrobromide for Suspension', 'type': 'DRUG', 'otherNames': ['VV116'], 'description': '15 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times.\n\n20 mg/kg BID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension once every 12 hours, total 10 times.\n\n20 mg/kg TID group: 15 subjects will receive Deuremidevir Hydrobromide for Suspension 3 times every day, total 15 times.', 'armGroupLabels': ['Deuremidevir Hydrobromide for Suspension']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['VV116 placebo'], 'description': '15 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times.\n\n20 mg/kg BID group: 5 subjects will receive placebo once every 12 hours, total 10 times.\n\n20 mg/kg TID group: 5 subjects will receive placebo 3 times every day, total 15 times.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The first Affiliated hospital of Bengbu Medical University', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Chongqing University Jiangjin Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '361006', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': "Xiamen Children's Hospital", 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Xiamen Maternity and Child Healthcare Hospital', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Women and Children's Hospital and Health Institute", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Panyu Maternal and Child care Service centre of Guangzhou', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Sceond Affiliated hospital of Shantou University Medical college', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '518106', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen Guangming District People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '545006', 'city': 'Liuchow', 'state': 'Guangxi', 'country': 'China', 'facility': "Liuzhou People's Hospital", 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': "Hainan women and children's Medical centre", 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Sanmenxia', 'state': 'Henan', 'country': 'China', 'facility': 'Sanmenxia Central Hospital', 'geoPoint': {'lat': 34.78081, 'lon': 111.19287}}, {'city': 'Changde', 'state': 'Hunan', 'country': 'China', 'facility': "Changde First people's Hospital", 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Provincial Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '215003', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Children's Hospital of Soochow University", 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Jiangxi Maternal and Child Health', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': "Liaocheng People's Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'zip': '041000', 'city': 'Linfen', 'state': 'Shanxi', 'country': 'China', 'facility': 'Linfen Central Hospital', 'geoPoint': {'lat': 36.08889, 'lon': 111.51889}}, {'city': 'Mianyang', 'state': 'Sichuan', 'country': 'China', 'facility': 'Mianyang Central Hospital', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Shulan (hangzhou) Hosipital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Children's Hospital of Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First people's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'lanjuan li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shulan (Hangzhou) Hospital'}, {'name': 'Zhen Qin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shulan (Hangzhou) Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vigonvita Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}