Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-02-09 @ 9:32 PM
Study NCT ID:
NCT05398705
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2022-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C006947', 'term': 'cepharanthine'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection in alternate care site will be randomized (1:1:1) to receive low-dose cepharanthine, high-dose cepharanthine or placebo orally every 8 hours for 5 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2022-05-29', 'studyFirstSubmitQcDate': '2022-05-29', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to viral clearance', 'timeFrame': 'Day 1 through Day 28', 'description': 'The time to viral clearance was defined as first positive nucleic acid test（or randomization） to the date of the first negative test (in two consecutive point)'}, {'measure': 'SARS-CoV-2 viral load', 'timeFrame': 'Day 1 through Day 28', 'description': 'SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value\\>35 for both ORF1ab and N gene was considered as negativity.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants developing COVID-19 pneumonia', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Proportion of participants developing severe pneumonia', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of CEP relative to placebo.', 'timeFrame': 'Day 1 through Day 28'}, {'measure': 'Number of days from the onset of fever until the temperature drops below 37.3°C', 'timeFrame': 'Day 1 through Day 28'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asymptomatic COVID-19', 'cepharanthine', 'adult'], 'conditions': ['Asymptomatic COVID-19']}, 'referencesModule': {'references': [{'pmid': '35579892', 'type': 'RESULT', 'citation': 'Shen Y, Ai J, Lin N, Zhang H, Li Y, Wang H, Wang S, Wang Z, Li T, Sun F, Fan Z, Li L, Lu Y, Meng X, Xiao H, Hu H, Ling Y, Li F, Li H, Xi C, Gu L, Zhang W, Fan X. An open, prospective cohort study of VV116 in Chinese participants infected with SARS-CoV-2 omicron variants. Emerg Microbes Infect. 2022 Dec;11(1):1518-1523. doi: 10.1080/22221751.2022.2078230.'}, {'pmid': '35172054', 'type': 'RESULT', 'citation': 'Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.'}, {'pmid': '39890847', 'type': 'DERIVED', 'citation': 'Wei J, Liu S, Bian Y, Li L, Qian B, Shen Z, Zhang Y, Abuduaini A, Dong F, Zhang X, Li J, Yu Y, Zhang W, Wang J, Zhai W, Song Q, Zheng Y, Pan W, Yu L, Zhan Q, Zhang N, Zheng J, Pan S, Yao C, Li H. Safety and efficacy of oral administrated cepharanthine in non-hospitalized, asymptomatic or mild COVID-19 patients: a Double-blind, randomized, placebo-controlled trial : Author detials. Sci Rep. 2025 Jan 31;15(1):3875. doi: 10.1038/s41598-024-75891-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of high/low-dose cepharanthine for the Treatment of COVID-19 in asymptomatic and non-pneumonia mild adult participants with COVID-19 who do not need to be in the hospital, but in alternate care site.', 'detailedDescription': 'Screening participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.\n\nPatients will be randomized to one of three arms, all participants will receive standardized medical treatment (SMT) according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.\n\n* low-dose experimental arm：cepharanthine 60mg/day + SMT\n* high-dose experimental arm：cepharanthine 120mg/day + SMT\n* placebo control arm：placebo + SMT\n\nThe primary outcome measure is the time to viral clearance which defined as first positive nucleic acid test to the date of the first negative test (in two consecutive point). SARS-CoV-2 viral load was detected and quantified by RT-PCR using nasopharyngeal swabs . Ct value\\>35 for both ORF1ab and N gene was considered as negativity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged over 16 years old with all genders\n* SARS-CoV-2 positive（laboratory-confirmed reverse transcription polymerase chain reaction (RT PCR) test)\n* patient or immediate adult family member agrees to participate in this study and signs an informed consent form\n* asymptomatic or patients with mild covid-19 symptoms\n* confirmed SARS-CoV-2 infection within 5 days prior to randomization\n\nExclusion Criteria:\n\n* Confirmed SARS-CoV-2 infection within \\> 5 days prior to randomization\n* CT shows pneumonia on admission\n* diagnosed as severe or critical COVID-19 before intervention\n* has a history of chronic underlying disease and acute exacerbation of that underlying disease at the time of admission\n* Females who are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05398705', 'briefTitle': 'Study of Oral High/Low-dose Cepharanthine Compared With Placebo in Non Hospitalized Adults With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'An Interventional Efficacy and Safety, Phase 2, Double-blind, 3-arm Study to Investigate Orally Administered High/Low-dose Cepharanthine Compared With Placebo in Nonhospitalized Asymptomatic or Mild Adult Participants With COVID-19', 'orgStudyIdInfo': {'id': 'CEP-Omicron'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose cepharanthine + standardized medical treatment', 'description': 'Drug: cepharanthine (tablet) Day 1\\~5: 20mg, Q8H X 5 days + standardized medical treatment', 'interventionNames': ['Drug: Cepharanthine']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose cepharanthine + standardized medical treatment', 'description': 'Drug: cepharanthine (tablet) Day 1\\~5: 40mg, Q8H X 5 days + standardized medical treatment', 'interventionNames': ['Drug: Cepharanthine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo+standardized medical treatment', 'description': 'Drug: cepharanthine placebo (tablet) Day 1\\~5: placebo + standardized medical treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cepharanthine', 'type': 'DRUG', 'otherNames': ['Low- dose Cepharanthine (tablet)'], 'description': 'Low-dose: Day 1\\~5: 20mg, Q8H X 5 days (60mg/day)+SMT', 'armGroupLabels': ['Low-dose cepharanthine + standardized medical treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo (tablet)'], 'description': 'Day 1\\~5: placebo+SMT\n\nSMT:standardized medical treatment according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor, antiviral drug and Chinese medicine treatment, etc.', 'armGroupLabels': ['placebo+standardized medical treatment']}, {'name': 'Cepharanthine', 'type': 'DRUG', 'otherNames': ['High- dose Cepharanthine (tablet)'], 'description': 'High-dose: Day 1\\~5: 40mg, Q8H X 5 days (120mg/day) +SMT\n\nSMT:standardized medical treatment according to Scheme for Diagnosis and Treatment of 2019 Novel Coronavirus Pneumonia (The 9th Trial Edition) from health commission of China, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and Chinese traditional medicine, etc.', 'armGroupLabels': ['High-dose cepharanthine + standardized medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao TongUniversity', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Hai Li, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If shared, including protocol, case report form (CRF), Statistical Analysis Plan (SAP), etc.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'YUNNAN BAIYAO GROUP CO.,LTD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of department of gastroenterological division, Renji Hospital', 'investigatorFullName': 'Hai Li', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}