Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 11:58 PM
Study NCT ID:
NCT06873633
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'C000606551', 'term': 'remdesivir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-07', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of Remdesivir', 'timeFrame': '1 Week', 'description': 'Outcome Measures:\n\nOccurrence of the following events from the time of randomization until the last study visit:\n\n* serious adverse events (SAEs);\n* adverse events (AEs) of Grade 3 or higher\n* treatment-related AEs\n* AEs leading to treatment discontinuation\n* treatment-related AEs leading to treatment discontinuation\n* AEs of Grade 3 or higher leading to treatment discontinuation\n\nAcceptability of daily remdesivir infusions to children, health care personnel, and caregivers assessed through questionnaires and direct observation.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the RSV RNA viral load', 'timeFrame': '1 Week', 'description': 'Outcome measures:\n\n* Reduction in RSV RNA viral load reduction from Day 1 to Day 6, i.e. one day after the end of treatment.\n* Time from Day 1 to RSV RNA viral load drop below the RT-PCR quantification limit until Day 6.\n* Area under the RSV RNA viral load-time curve (AUC) from Day 1 until Day 6.'}, {'measure': 'Efficacy of Remdesivir', 'timeFrame': '1 Week', 'description': 'Ourtome Measures:\n\nImprovement on the PRESS 6-step ordinal scale from Day 1 until Day 6. PK parameters will be estimated for remdesivir and its metabolites GS-704277 and GS-44152417.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiration disorders', 'RSV infection', 'Respiratory Syncytial Virus Hospitalizations'], 'conditions': ['Respiratory Syncytial Virus (RSV)']}, 'descriptionModule': {'briefSummary': "THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir (VEKLURY®) in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.", 'detailedDescription': 'An overall target of 120 participants will be involved in the study. Eligible participants will be randomized (1:1) to receive ARM 1: Standard of care alone (control arm). ARM 2: Remdesivir in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days. Each participant will be followed during hospitalization plus 7-10 days after Day 6\\* for final visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent from parents/caregivers\n* Aged 0 to \\<2 years\n* Weighing at least 2.0 kg\n* Onset of RSV associated-symptoms within 1 week of screening\n* Confirmed\\* with RSV infection (by rapid antigen test or RT PCR)\n* Hospitalized children fulfilling at least two of the following three RSV disease severity criteria:\n\n * Inadequate oral feeding\n * Inadequate oxygen saturation (peripheral capillary oxygen saturation \\[SpO2\\] \\<95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%)\n * Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use \\[subcostal, intercostal, or suprasternal retraction\\], or both)\n\nExclusion Criteria:\n\n* Preterm infants (gestational age at birth less than 37 weeks) who are aged \\<56 days\n* Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)\n* Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \\<24 hours prior to study drug dosing (e.g. ribavirin)\n* ALT or AST \\> 5 × ULN\n* eGFR \\<30 mL/min/1.73m2 using the Schwartz formula if aged ≥1 year; or if aged \\<1 year based on a creatinine value cut off dependent on chronological age\n* Any major congenital renal anomaly if \\<28 days\n* Apgar score \\< 5 when last recorded if age \\<24 hours\n* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.\n* On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)\n* Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives'}, 'identificationModule': {'nctId': 'NCT06873633', 'acronym': 'THAI-CARES RSV', 'briefTitle': 'Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV', 'organization': {'class': 'NETWORK', 'fullName': 'PENTA Foundation'}, 'officialTitle': 'A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.', 'orgStudyIdInfo': {'id': 'THAI-CARES RSV'}, 'secondaryIdInfos': [{'id': 'CO-US-540-7443', 'type': 'OTHER_GRANT', 'domain': 'Gilead'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of care (control arm).', 'description': 'Standard of care treatments will be delivered according to local practice at each hospital. The standard of care for lower respiratory tract infection includes oxygen therapy as needed, bronchodilators, intravenous fluids, in some cases the use of steroids, antibiotics and any treatment for underlying disease.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': "Remdesivir will be used in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days with a dosage based on the participant's weight at the time of the randomisation.", 'interventionNames': ['Drug: Remdesivir']}], 'interventions': [{'name': 'Remdesivir', 'type': 'DRUG', 'otherNames': ['VEKLURY®'], 'description': 'Remdesivir (RDV) has shown potent antiviral activity against RSV A in an animal model. Remdesivir has been also shown to be a safe treatment option in pediatric patients hospitalized with COVID-19. Based on previous clinical evidence and preclinical data, to address the unmet medical need for safe and effective RSV therapy, this study is being conducted to investigate remdesivir in infants and children (aged 0 days to \\<2 years) as a potential treatment for RSV infection.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Napaporn Chantasrisawad', 'role': 'CONTACT', 'email': 'napaporn.cha@chula.ac.th', 'phone': '+662-2564930'}, {'name': 'Napaporn Chantasrisawad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50180', 'city': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suparat Kanjanavanit', 'role': 'CONTACT', 'email': 'skanjanavanit@gmail.com', 'phone': '+6653-999000', 'phoneExt': 'Ext.0'}, {'name': 'Suparat Kanjanavanit', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nakornping Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '50200', 'city': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Tavitiya Sudjaritruk', 'role': 'CONTACT', 'email': 'tavitiya.s@cmu.ac.th', 'phone': '+66053 936 150'}, {'name': 'Tavitiya Sudjaritruk', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maharaj Nakorn Chiang Mai Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '5700', 'city': 'Chiang Rai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suchada Ruenglerdpong', 'role': 'CONTACT', 'email': 'suchada.lan.rueng@gmail.com', 'phone': '+6653 910 600'}, {'name': 'Suchada Ruenglerdpong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chiangrai Prachanukroh Hospital', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}, {'zip': '40000', 'city': 'Khon Kaen', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Ussanee Srirompotong', 'role': 'CONTACT', 'email': 'u.srirompotong@gmail.com', 'phone': '+6643 009 900'}, {'name': 'Ussanee Srirompotong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Khon Kaen Hospital', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '52000', 'city': 'Lampang', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Mallika Rattanawijit', 'role': 'CONTACT', 'email': 'mrattana121@gmail.com', 'phone': '+6654 237 400'}, {'name': 'Mallika Rattanawijit', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lampang Hospital', 'geoPoint': {'lat': 18.29232, 'lon': 99.49277}}, {'zip': '44000', 'city': 'Maha Sarakham', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Supawan Papakhee', 'role': 'CONTACT', 'email': 'supawan.pa@chula.ac.th', 'phone': '+6643 723 355'}, {'name': 'Supawan Papakhee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mahasarakham Hospital', 'geoPoint': {'lat': 16.18483, 'lon': 103.30067}}, {'zip': '74000', 'city': 'Samut Sakhon', 'status': 'NOT_YET_RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Shalini Sachdev', 'role': 'CONTACT', 'email': 'shalu.sachdev84@gmail.com', 'phone': '+6634 429333'}, {'name': 'Shalini Sachdev', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samut Sakhon Hospital', 'geoPoint': {'lat': 13.54753, 'lon': 100.27362}}], 'centralContacts': [{'name': "Federica D'Ambrosio", 'role': 'CONTACT', 'email': 'federica.dambrosio@pentafoundation.org', 'phone': '+39 049 716 9848'}], 'overallOfficials': [{'name': 'Tim R Cressey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University'}, {'name': 'Tavitiya Sudjaritruk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Faculty of Medicine, Chiang Mai University'}, {'name': 'Pablo Rojo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Materno Infantil 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PENTA Foundation', 'class': 'NETWORK'}, 'collaborators': [{'name': 'AMS-PHPT Research Collaboration', 'class': 'UNKNOWN'}, {'name': 'Chiang Mai University', 'class': 'OTHER'}, {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}