Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05075304
Other study ID # STS-BDB001-02
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 21, 2020
Est. completion date April 14, 2020

Study information

Verified date August 2021
Source Staidson (Beijing) Biopharmaceuticals Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date April 14, 2020
Est. primary completion date April 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 18= age =60, 18 kg/m2 =BMI =28 kg/m2, male or female; - Diagnosed with 2019-nCoV infection and classified clinically as mild or general; - Agreed not to participate in other clinical studies before completing this study; - With the subject's consent and signed informed consent form by the subject or his/her legal representative. Exclusion Criteria: - Diagnosed with 2019-nCoV infection and classified clinically as severe or critical severe; severe pneumonia or acute respiratory distress syndrome, sepsis and septic shock; - The disease would deteriorate significantly within 48 hours judged by the investigators; - Immunodeficiency or immune related diseases not suitable for participation judged by the investigators (such as autoimmune diseases, IgG4 related diseases, allergic alveolitis, vasculitis, etc); - Lymphocyte count <0.5×109/L; - Neutropenia history (neutrophil absolute count was less than 2×109/L in adults), except for infection; - D- dimer >2000 µg/L; - 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; - The subjects used the following drugs within 2 weeks (including 2 weeks) before screening: 1. Calcineurin inhibitors (such as cyclosporin and tacrolimus); 2. Proliferation inhibitors (such as everolimus, sirolimus, etc); 3. anti-metabolic agents (such as mycophenolate mofetil, mycophenolic acid, purine sulfate, etc); - Pregnant or lactating women.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BDB-001 injection
IV infusions of Injection diluted in sodium chloride
BDB-001 injection
IV infusions of Injection diluted in sodium chloride
BDB-001 injection
IV infusions of Injection diluted in sodium chloride

Locations

Country Name City State
China Shu Lan (Hangzhou) Hospital Hangzhou Zhejiang
China Sanya Central Hospital (Hainan Third People'S Hospital) Sanya Hainan
China General Hospital of Gentral Rheater Command Wuhan Hubei
China Renmin Hospital Of Wuhan University Bubei General Hospital Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd Beijing Defengrui Biotechnology Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with serious adverse events (SAEs) and non-serious adverse events 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. Up to Day 40
Primary Number of participants with abnormal laboratory tests Blood samples were collected for the assessment of laboratory tests. Number of participants with abnormal laboratory tests parameters are presented. Up to Day 40
Primary Number of participants with physical examination Blood samples were collected for the assessment of physical examination. Number of participants with abnormal physical examination parameters are presented. Up to Day 40
Primary Number of participants with abnormal vital signs 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. Up to Day 40
Primary Number of participants with abnormal electrocardiogram (ECG) findings Number of participants with abnormality Abnormal Electrocardiogram (ECG) are presented. Up to Day 40
Primary Plasma concentration of BDB-001 following intravenous administration 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. 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.
Primary Plasma concentration of ADA Within 60 minutes (prior to start of the first and second BDB-001 IV infusion), Day 7 24 hours after infusion, day 14.
See also
  Status Clinical Trial Phase
Recruiting NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Active, not recruiting NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Spikogen Booster Study Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure