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Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)

Primary Purpose

COVID-19, SARS-CoV-2

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
JS016
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, JS016, spike (S) protein, SARS-CoV-2

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) infection
  • 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:

  • Sever Covid-19 Infection patients
  • 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

Sites / Locations

  • Li WengRecruiting
  • Shi Jiazhuang People's HospitalRecruiting
  • The First Affliated Hospital of Harbin Medical UniversityRecruiting
  • Suihua first hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

JS016 treatment group

Control group

Arm Description

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.

Standard therapy Standard therapy includes vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition.

Outcomes

Primary Outcome Measures

Clinical status at 28 days
Clinical status at 28 days assessed using a six level ordinal scale，in this scale, 1 is the minimum score and presenting a better outcome as discharge, 2 means still in-hospital but no need of oxygen therapy, 3 presents in-hospital and needing of oxygen therapy, 4 presents in-hospital needing high flow nasal oxygen therapy or non-invasive mechanical ventilation, 5 presents in-hospital needing invasive mechanical ventilation or ECMO, 6 presents death and is the worse outcome as well.

Secondary Outcome Measures

All cause mortality ascertained from data analysed to day 28
All cause mortality ascertained from data analysed to day 28
Ventilator-free days within 28 days
Ventilator-free days within 28 days
Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization
Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after
Average length of hospital stay
Average length of hospital stay

Full Information

First Posted
June 13, 2021
Last Updated
October 13, 2021
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04931238
Brief Title
Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)
Official Title
Efficacy and Safety of a Recombinant Neutralizing Human Anti-SARS-CoV-2 Monoclonal Antibody JS016 in Chinese Hospitalized Patients With SARS-CoV-2 Infection (COVID-19): a Multicenter, Randomized, Open-label, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.
Detailed Description
As the COVID-19 pandemic is emerging as a global healthcare crisis, scientists worldwide are actively developing prophylactic and therapeutic interventions. Neutralizing antibody therapies are being developed for the treatment of COVID-19. The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. The LALA mutation was introduced to the Fc portion of CB6 (CB6-LALA) to lower the risk of Fc-mediated acute lung injury in animals. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19. The data from this study will inform decisions of the clinical use of JS016.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
COVID-19, JS016, spike (S) protein, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JS016 treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard therapy Standard therapy includes vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition.
Intervention Type
Drug
Intervention Name(s)
JS016
Other Intervention Name(s)
CB6-LALA
Intervention Description
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Primary Outcome Measure Information:
Title
Clinical status at 28 days
Description
Clinical status at 28 days assessed using a six level ordinal scale，in this scale, 1 is the minimum score and presenting a better outcome as discharge, 2 means still in-hospital but no need of oxygen therapy, 3 presents in-hospital and needing of oxygen therapy, 4 presents in-hospital needing high flow nasal oxygen therapy or non-invasive mechanical ventilation, 5 presents in-hospital needing invasive mechanical ventilation or ECMO, 6 presents death and is the worse outcome as well.
Time Frame
At 28 days from inclusion
Secondary Outcome Measure Information:
Title
All cause mortality ascertained from data analysed to day 28
Description
All cause mortality ascertained from data analysed to day 28
Time Frame
At 28 days from inclusion
Title
Ventilator-free days within 28 days
Description
Ventilator-free days within 28 days
Time Frame
At 28 days from inclusion
Title
Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization
Description
Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after
Time Frame
At 14 days from inclusion
Title
Average length of hospital stay
Description
Average length of hospital stay
Time Frame
At 28 days from inclusion
Other Pre-specified Outcome Measures:
Title
The incidence Treatment-Emergent Adverse Events of JS016
Description
Incidence of Treatment-Emergent Adverse Events of JS016 includes the incidence of allergic reaction, secondary infection, liver dysfunction, acute kidney injury.
Time Frame
Everyday after inclusion up to 28 days from inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) infection 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: Sever Covid-19 Infection patients 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin DU, Prof.
Phone
+86 13601366216
Email
dubin98@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Weng, Prof.
Phone
+86 18600017819
Email
wengli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin DU, Prof.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Li Weng
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Weng, professor
Phone
15601348897
Email
wengli@gmail.com
First Name & Middle Initial & Last Name & Degree
Bin Du, professor
Phone
+8618600017819
Email
dubin98@gmail.com
Facility Name
Shi Jiazhuang People's Hospital
City
Shijia Zhuang
State/Province
He Bei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinying Cao, Prof.
Phone
+86 13363882361
Email
sjzcqy@126.com
First Name & Middle Initial & Last Name & Degree
Ling Cui, Master
Facility Name
The First Affliated Hospital of Harbin Medical University
City
Harbin
State/Province
Hei Longjiang
ZIP/Postal Code
0451
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaijiang Yu, MD
Phone
010-13303608899
Email
kaijiangyu002@163.com
First Name & Middle Initial & Last Name & Degree
Kaijiang Yu, MD
Facility Name
Suihua first hospital
City
Suihua
State/Province
Hei Longjiang
ZIP/Postal Code
0455
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinyang Zhang, Prof.
Phone
+86 13804867215
Email
xinshuang_1986@126.com
First Name & Middle Initial & Last Name & Degree
Xibin Wang, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33215063
Citation
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.
Results Reference
result
PubMed Identifier
35713300
Citation
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.
Results Reference
derived
PubMed Identifier
35191746
Citation
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.
Results Reference
derived

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Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)

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