Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT05075304
Status:
TERMINATED
Last Update Posted:
2024-05-21
First Post:
2021-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients
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': 'C000719787', 'term': 'BDB001'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2021-08-22', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with serious adverse events (SAEs) and non-serious adverse events', 'timeFrame': 'Up to Day 40', 'description': 'An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented.'}, {'measure': 'Number of participants with abnormal laboratory tests', 'timeFrame': 'Up to Day 40', 'description': 'Blood samples were collected for the assessment of laboratory tests. Number of participants with abnormal laboratory tests parameters are presented.'}, {'measure': 'Number of participants with physical examination', 'timeFrame': 'Up to Day 40', 'description': 'Blood samples were collected for the assessment of physical examination. Number of participants with abnormal physical examination parameters are presented.'}, {'measure': 'Number of participants with abnormal vital signs', 'timeFrame': 'Up to Day 40', 'description': 'Vital signs were measured in a semi-supine position after five minutes of rest and included temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) , heart rate, respiratory rate. Number of participants with abnormality in any vital signs are presented.'}, {'measure': 'Number of participants with abnormal electrocardiogram (ECG) findings', 'timeFrame': 'Up to Day 40', 'description': 'Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented.'}, {'measure': 'Plasma concentration of BDB-001 following intravenous administration', 'timeFrame': 'Within 60 minutes (prior to start of BDB-001 IV infusion), 10 minutes (end of infusion); at 6, 12,24, 48 hours after end of infusion.', 'description': 'Blood samples were collected at indicated time points for measurement of Plasma concentrations of BDB-001 following intravenous administration. Pharmacokinetic Population comprised of all participants for whom at least one evaluable pharmacokinetic sample was obtained and analyzed.'}, {'measure': 'Plasma concentration of ADA', 'timeFrame': 'Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'This open, multi-center, multiple ascending dose study was designed to evaluate the safety, tolerability, preliminary efficacy and PK/PD of BDB-001 injection in patients with mild, or general COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18≤ age ≤60, 18 kg/m2 ≤BMI ≤28 kg/m2, male or female;\n* Diagnosed with 2019-nCoV infection and classified clinically as mild or general;\n* Agreed not to participate in other clinical studies before completing this study;\n* With the subject's consent and signed informed consent form by the subject or his/her legal representative.\n\nExclusion Criteria:\n\n* Diagnosed with 2019-nCoV infection and classified clinically as severe or critical severe; severe pneumonia or acute respiratory distress syndrome, sepsis and septic shock;\n* The disease would deteriorate significantly within 48 hours judged by the investigators;\n* Immunodeficiency or immune related diseases not suitable for participation judged by the investigators (such as autoimmune diseases, IgG4 related diseases, allergic alveolitis, vasculitis, etc);\n* Lymphocyte count \\<0.5×109/L;\n* Neutropenia history (neutrophil absolute count was less than 2×109/L in adults), except for infection;\n* D- dimer \\>2000 µg/L;\n* Severe history of lung diseases, such as chronic obstructive pulmonary disease, lung cancer, tuberculosis, etc., history of heart disease: unstable angina pectoris, myocardial infarction, cardiac surgery, cardiac function≥ grade 3 (NYHA classification), serious history of liver disease (such as Child Pugh score ≥grade C), serious renal disease history, such as renal insufficiency (GFR ≤ 15ml/min/1.73m2), etc;\n* The subjects used the following drugs within 2 weeks (including 2 weeks) before screening:\n\n 1. Calcineurin inhibitors (such as cyclosporin and tacrolimus);\n 2. Proliferation inhibitors (such as everolimus, sirolimus, etc);\n 3. anti-metabolic agents (such as mycophenolate mofetil, mycophenolic acid, purine sulfate, etc);\n* Pregnant or lactating women."}, 'identificationModule': {'nctId': 'NCT05075304', 'briefTitle': 'A Safety and Tolerability Study of BDB-001 in Mild, Moderate COVID-19 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Staidson (Beijing) Biopharmaceuticals Co., Ltd'}, 'officialTitle': 'A Phase Ib, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BDB-001 Injection in Patients With Novel Coronavirus (2019-nCoV) Infection', 'orgStudyIdInfo': {'id': 'STS-BDB001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A low dose of BDB-001', 'description': '6 patients administered low dose of BDB-001 injection', 'interventionNames': ['Drug: BDB-001 injection']}, {'type': 'EXPERIMENTAL', 'label': 'A intermediate dose of BDB-001', 'description': '6 patients administered intermediate dose of BDB-001 injection', 'interventionNames': ['Drug: BDB-001 injection']}, {'type': 'EXPERIMENTAL', 'label': 'A high dose of BDB-001', 'description': '3-6 patients administered high dose of BDB-001 injection', 'interventionNames': ['Drug: BDB-001 injection']}], 'interventions': [{'name': 'BDB-001 injection', 'type': 'DRUG', 'description': 'IV infusions of Injection diluted in sodium chloride', 'armGroupLabels': ['A low dose of BDB-001']}, {'name': 'BDB-001 injection', 'type': 'DRUG', 'description': 'IV infusions of Injection diluted in sodium chloride', 'armGroupLabels': ['A intermediate dose of BDB-001']}, {'name': 'BDB-001 injection', 'type': 'DRUG', 'description': 'IV infusions of Injection diluted in sodium chloride', 'armGroupLabels': ['A high dose of BDB-001']}]}, 'contactsLocationsModule': {'locations': [{'zip': '572000', 'city': 'Sanya', 'state': 'Hainan', 'country': 'China', 'facility': "Sanya Central Hospital (Hainan Third People'S Hospital)", 'geoPoint': {'lat': 18.25435, 'lon': 109.50947}}, {'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hospital Of Wuhan University Bubei General Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430070', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'General Hospital of Gentral Rheater Command', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Shu Lan (Hangzhou) Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Staidson (Beijing) Biopharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Defengrui Biotechnology Co. Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}