Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)
NCT ID: NCT04931238
Last Updated: 2021-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2021-01-20
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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JS016 treatment group
Standard therapy + JS016 injection Standard therapy including vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition.
JS016
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Control group
Standard therapy Standard therapy includes vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition.
No interventions assigned to this group
Interventions
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JS016
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Within 7 days from the onset of clinical symptoms or 4 days from the onset of severe symptoms
* Consistent with the National Health Committee New Coronavirus pneumonia diagnosis and treatment plan (Eighth Edition), general or heavy diagnostic criteria.
Exclusion Criteria
* SARS-Cov-2 specific antibodies (including IgM and IgG) were positive before included
* Cardiac function grade III or IV, or left ventricular ejection fraction \< 30%
* History of known or suspected active pulmonary tuberculosis or extra-pulmonary tuberculosis
* Chronic renal failure needs maintenance dialysis
* History of solid malignant/tumor or hematological malignancy
* Pregnancy or lactation
18 Years
85 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Bin DU, Prof.
Role: STUDY_CHAIR
Peking Union Medical College Hospital
Locations
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Li Weng
Beijing, Beijing Municipality, China
Shi Jiazhuang People's Hospital
Shijiazhuang, Hebei, China
The First Affliated Hospital of Harbin Medical University
Harbin, Hei Longjiang, China
Suihua first hospital
Suihua, Hei Longjiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yang L, Liu W, Yu X, Wu M, Reichert JM, Ho M. COVID-19 antibody therapeutics tracker: a global online database of antibody therapeutics for the prevention and treatment of COVID-19. Antib Ther. 2020 Jul;3(3):205-212. doi: 10.1093/abt/tbaa020. Epub 2020 Aug 19.
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Dong R, Jiang L, Yang T, Wang C, Zhang Y, Chen X, Xie J, Guo Y, Weng L, Kang Y, Yu K, Qiu H, Du B; China Critical Care Clinical Trials Group (CCCCTG). Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody JS016 in Hospitalized Chinese Patients with COVID-19: a Phase 2/3, Multicenter, Randomized, Open-Label, Controlled Trial. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0204521. doi: 10.1128/AAC.02045-21. Epub 2022 Mar 15.
Other Identifiers
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Peking JS016
Identifier Type: -
Identifier Source: org_study_id