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JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)
Placebo
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age of 18-65 years (inclusive) ,women or man
  2. SARS-CoV-2 detected in the diagnostic specimen (nasopharyngeal swab)
  3. High homology of viral gene sequencing with the known SARS-CoV-2."
  4. Mild/moderateillness COVID-19 or SARS-CoV-2 asymptomatic infection
  5. Within 7 days from the onset time of symptoms to randomization or within 5 days from the first time of SARS-CoV-2 positive test to randomization with required viral load
  6. No plan of pregnancy and being willing to use effective contraceptive measures
  7. Signed the informed consent form, sufficiently understanding of the content

Exclusion Criteria:

  1. positive IgM/IgG against SARS-CoV-2 prior to randomization.
  2. Severeor critical illness
  3. Uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases
  4. Type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes
  5. Liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases
  6. History of SARS-CoV-2 vaccination or participation in clinical trial with neutralizing antibody against SARS-CoV-2.
  7. Use of therapeutic biologics within 3 months prior to screening, or within the elimination period (5 half-lives) of such drugs as the day of dosing
  8. Has participated in any other interventional clinical study involving anstudy drug within 3 months prior to screening, or within the elimination period (5 half-lives) of the study drug as the day of dosing
  9. Platelets and hemoglobin test results during screening period are abnormal and have clinical significanc.
  10. Anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others

Sites / Locations

  • Beijing Ditan Hospital affiliated to Capital Medical University
  • Huashan Hospital affiliated to Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anti-SARS-CoV-2 Monoclonal Antibody dose 1/2/3

Placebo

Arm Description

use Anti-SARS-CoV-2 Monoclonal Antibody,dose 1/2/3 to treat COVID-19

use placebo to treat COVID-19

Outcomes

Primary Outcome Measures

Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples)
Time to negative conversion in viral nucleic acid test (by RT-PCR) for diagnostic samples, negative conversion is defined as two consecutive negative nucleic acid test for diagnostic samples after randomization
Safety Measurements : 90 of participants with treatment-related adverse events as assessed byCTCAE v5.0
Any adverse event, serious adverse events (SAEs) occurring during the clinical study, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, myocardial enzymogram, etc.) and abnormality of 12-lead ECGs will be observed for all the participants

Secondary Outcome Measures

PK Measures:AUC0-tau
Area under the plasma drug concentration-time curve from time 0 to one dosing interval (AUC0-tau)
PK Measures：Cmax
Maximum plasma drug concentration after administration (Cmax)
PK Measures：Tmax
Time to the maximum plasma drug concentrations after administration (Tmax)
PK Measures：t1/2
Terminal half life (t1/2)
PK Measures：CL
Total clearance (CL)
PK Measures：Vd
Apparent volume of distribution (Vd)
Proportions of participants with negative conversion in viral nucleic acid test
Proportions of participants with negative conversion in viral nucleic acid test 7 days and 14 days after administration (performed on each day of the first week after dosing, every other day of the 2nd week, once a week from the 3rd week)
Viral load change from baseline
Viral load change from baseline (performed on each day of the first week after dosing, every other day of the 2nd week, once a week from the 3rd week)
Pulmonary CT（observe by imaging reports to degree of pulmonary inflammation, degree of vitreous fibrosis)
Pulmonary CT changes during the study period

Full Information

First Posted
September 23, 2020
Last Updated
July 14, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04780321
Brief Title
JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy, Safety, Pharmacokinetic Profiles and Immunogenicity of JS016 in Participants With Mild and Moderate COVID-19 or of SARS-CoV-2 Asymptomatic Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
JS016-002-Ib/II is a randomized, double-blinded, placebo-controlled study, to investigate the safety, PK profiles, preliminary efficacy and immunogenicity of intravenous Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody (JS016) in participants with mild and moderate COVID-19 or of SARS-CoV-2 Asymptomatic Infection. Three doses of JS016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given as single dose of intravenous infusion. In total, 90 participants will be enrolled with 30 participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive investigational product or placebo treatment, respectively.
Detailed Description
"Each participant will receive JS016 or matched placebo intravenous infusion on D1 (randomizing day). Non-pharmaceutical supportive background therapy (e.g. oxygen inhalation) for COVID-19 is allowed per clinical needs. Investigators will be kept blinded to review the preliminary efficacy and safety data on a regular basis. Meanwhile, a study evaluation team (SET) composed of medical monitors, safety assessors and statisticians will be set up to review the study status, safety and preliminary efficacy of the participants at the pre-specified time points or as necessary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-SARS-CoV-2 Monoclonal Antibody dose 1/2/3
Arm Type
Active Comparator
Arm Description
use Anti-SARS-CoV-2 Monoclonal Antibody,dose 1/2/3 to treat COVID-19
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
use placebo to treat COVID-19
Intervention Type
Biological
Intervention Name(s)
Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)
Intervention Description
use dose 1/2/3 60 patients receipt JS016 intravenous infusion on day 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
30 patients receipt placebo intravenous infusion on day 1
Primary Outcome Measure Information:
Title
Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples)
Description
Time to negative conversion in viral nucleic acid test (by RT-PCR) for diagnostic samples, negative conversion is defined as two consecutive negative nucleic acid test for diagnostic samples after randomization
Time Frame
0-85days
Title
Safety Measurements : 90 of participants with treatment-related adverse events as assessed byCTCAE v5.0
Description
Any adverse event, serious adverse events (SAEs) occurring during the clinical study, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, myocardial enzymogram, etc.) and abnormality of 12-lead ECGs will be observed for all the participants
Time Frame
0-85days
Secondary Outcome Measure Information:
Title
PK Measures:AUC0-tau
Description
Area under the plasma drug concentration-time curve from time 0 to one dosing interval (AUC0-tau)
Time Frame
Day 0 to Day 85
Title
PK Measures：Cmax
Description
Maximum plasma drug concentration after administration (Cmax)
Time Frame
Day 0 to Day 85
Title
PK Measures：Tmax
Description
Time to the maximum plasma drug concentrations after administration (Tmax)
Time Frame
Day 0 to Day 85
Title
PK Measures：t1/2
Description
Terminal half life (t1/2)
Time Frame
Day 0 to Day 85
Title
PK Measures：CL
Description
Total clearance (CL)
Time Frame
Day 0 to Day 85
Title
PK Measures：Vd
Description
Apparent volume of distribution (Vd)
Time Frame
Day 0 to Day 85
Title
Proportions of participants with negative conversion in viral nucleic acid test
Description
Proportions of participants with negative conversion in viral nucleic acid test 7 days and 14 days after administration (performed on each day of the first week after dosing, every other day of the 2nd week, once a week from the 3rd week)
Time Frame
Day 0 to Day 85
Title
Viral load change from baseline
Description
Viral load change from baseline (performed on each day of the first week after dosing, every other day of the 2nd week, once a week from the 3rd week)
Time Frame
Day 0 to Day 85
Title
Pulmonary CT（observe by imaging reports to degree of pulmonary inflammation, degree of vitreous fibrosis)
Description
Pulmonary CT changes during the study period
Time Frame
Day 0 to Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18-65 years (inclusive) ,women or man SARS-CoV-2 detected in the diagnostic specimen (nasopharyngeal swab) High homology of viral gene sequencing with the known SARS-CoV-2." Mild/moderateillness COVID-19 or SARS-CoV-2 asymptomatic infection Within 7 days from the onset time of symptoms to randomization or within 5 days from the first time of SARS-CoV-2 positive test to randomization with required viral load No plan of pregnancy and being willing to use effective contraceptive measures Signed the informed consent form, sufficiently understanding of the content Exclusion Criteria: positive IgM/IgG against SARS-CoV-2 prior to randomization. Severeor critical illness Uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases Type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes Liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases History of SARS-CoV-2 vaccination or participation in clinical trial with neutralizing antibody against SARS-CoV-2. Use of therapeutic biologics within 3 months prior to screening, or within the elimination period (5 half-lives) of such drugs as the day of dosing Has participated in any other interventional clinical study involving anstudy drug within 3 months prior to screening, or within the elimination period (5 half-lives) of the study drug as the day of dosing Platelets and hemoglobin test results during screening period are abnormal and have clinical significanc. Anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others
Facility Information:
Facility Name
Beijing Ditan Hospital affiliated to Capital Medical University
City
Beijing
ZIP/Postal Code
100010
Country
China
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived

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JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects

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