Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-01 @ 1:13 AM
Study NCT ID:
NCT05387369
Status:
RECRUITING
Last Update Posted:
2022-05-24
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719967', 'term': 'nirmatrelvir and ritonavir drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral shedding time', 'timeFrame': 'up to 28 days', 'description': 'time from the first positive testing to the first day of nucleic acid Ct value\\> 35 for both ORF1ab and N gene (in two consecutive).'}, {'measure': 'Percentage of the participants who have progression of COVID-19', 'timeFrame': 'up to 28 days', 'description': 'Percentage of participants who experience these events by Day 28 Progress to severe and/or critical COVID-19; Death from any cause'}], 'secondaryOutcomes': [{'measure': 'AEs and SAEs through Day 28', 'timeFrame': 'up to 28 days', 'description': 'Adverse events and Serious adverse events through Day 28'}, {'measure': 'Percentage of participants who turned negative for SARS-CoV-2', 'timeFrame': 'up to 28 days', 'description': 'Percentage of participants who turned negative for SARS-COV-2 at Day 3, 5, 7, 10, 14'}, {'measure': 'Time to sustained clinical recovery', 'timeFrame': 'up to 28 days', 'description': 'Time to sustained clinical recovery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['paxlovid'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The study was designed to analyze the efficacy and safety of Paxlovid for the treatment of COVID-19.', 'detailedDescription': 'The study is a real-world study and the case records of patients with COVID-19 who visit Huashan Hospital affiliated to Fudan University from 2022 to 2027 and receive Paxlovid therapy will be collected in this study. The medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COVID-19 who were admitted to Huashan Hospital, Fudan University from 2022 to 2027', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who have a positive SARS-CoV-2 test result;\n* Participants who have one or more mild or moderate COVID-19 symptoms.\n\nExclusion Criteria:\n\n* No specific exclusion criteria in this real world study.'}, 'identificationModule': {'nctId': 'NCT05387369', 'briefTitle': 'A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'A Real World Study of Paxlovid for the Treatment of Hospitalized Patients Confirmed With COVID-19', 'orgStudyIdInfo': {'id': 'KY2022-552'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Paxlovid', 'description': 'Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive Paxlovid therapy', 'interventionNames': ['Drug: Paxlovid']}, {'label': 'Routine therapy', 'description': 'Patients with COVID-19 who visit Huashan Hospital,Fudan University from 2022 to 2027 and receive routine therapy without paxlovid'}], 'interventions': [{'name': 'Paxlovid', 'type': 'DRUG', 'description': 'The study is a real-world study. According to the actual medical history of patients, the usage of paxlovid will be collected.', 'armGroupLabels': ['Paxlovid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiming Zhang, M.D.', 'role': 'CONTACT', 'email': 'jmzhang@vip.126.com', 'phone': '+86 021-52887948'}, {'name': 'Jiming Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Feng Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huashan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Feng Sun, MD', 'role': 'CONTACT', 'email': 'aaronsf1125@126.com', 'phone': '+86 02152889999'}], 'overallOfficials': [{'name': 'Feng Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital affliatied to Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jiming Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}