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

October 13, 2021 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100102
        • Recruiting
        • Li Weng
    • He Bei
      • Shijia Zhuang, He Bei, China
        • Recruiting
        • Shi Jiazhuang People's Hospital
        • Contact:
          • Qinying Cao, Prof.
          • Phone Number: +86 13363882361
          • Email: sjzcqy@126.com
        • Principal Investigator:
          • Ling Cui, Master
    • Hei Longjiang
      • Harbin, Hei Longjiang, China, 0451
        • Recruiting
        • The First Affliated Hospital of Harbin Medical University
        • Contact:
        • Principal Investigator:
          • Kaijiang Yu, MD
      • Suihua, Hei Longjiang, China, 0455
        • Recruiting
        • Suihua First Hospital
        • Contact:
        • Principal Investigator:
          • Xibin Wang, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: JS016
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Other Names:
  • CB6-LALA
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical status at 28 days
Time Frame: At 28 days from inclusion
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.
At 28 days from inclusion

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence Treatment-Emergent Adverse Events of JS016
Time Frame: Everyday after inclusion up to 28 days from inclusion
Incidence of Treatment-Emergent Adverse Events of JS016 includes the incidence of allergic reaction, secondary infection, liver dysfunction, acute kidney injury.
Everyday after inclusion up to 28 days from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Bin DU, Prof., Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Peking JS016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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