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AzTrials

COVID-19Phase 1/2NCT04780321

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

A Phase 1/2 study testing Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg) in people with COVID-19, run by Shanghai Junshi Bioscience Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID-19
What is being tested?
Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
2 sitesChina
Study dates
30 Oct 2020to 31 Aug 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Ditan Hospital affiliated to Capital Medical University

    Beijing, 100010

  • Huashan Hospital affiliated to Fudan University

    Shanghai

Other trials in China

About this study

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

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.

Read the 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.

Conditions
COVID-19
Being tested
Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg), Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)Biological

    use dose 1/2/3 60 patients receipt JS016 intravenous infusion on day 1

  • PlaceboDrug

    30 patients receipt placebo intravenous infusion on day 1

Study groups in NCT04780321
Study groupRoleWhat they receive
Anti-SARS-CoV-2 Monoclonal Antibody dose 1/2/3Active comparatoruse Anti-SARS-CoV-2 Monoclonal Antibody,dose 1/2/3 to treat COVID-19
Receives: Biological: Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)
PlaceboPlacebo comparatoruse placebo to treat COVID-19
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 0-85days

  2. 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

    Measured: 0-85days

Secondary outcomes (9)

  1. PK Measures:AUC0-tau

    Area under the plasma drug concentration-time curve from time 0 to one dosing interval (AUC0-tau)

    Measured: Day 0 to Day 85

  2. PK Measures：Cmax

    Maximum plasma drug concentration after administration (Cmax)

    Measured: Day 0 to Day 85

  3. PK Measures：Tmax

    Time to the maximum plasma drug concentrations after administration (Tmax)

    Measured: Day 0 to Day 85

  4. PK Measures：t1/2

    Terminal half life (t1/2)

    Measured: Day 0 to Day 85

  5. PK Measures：CL

    Total clearance (CL)

    Measured: Day 0 to Day 85

  6. PK Measures：Vd

    Apparent volume of distribution (Vd)

    Measured: Day 0 to Day 85

  7. 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)

    Measured: Day 0 to Day 85

  8. 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)

    Measured: Day 0 to Day 85

  9. Pulmonary CT（observe by imaging reports to degree of pulmonary inflammation, degree of vitreous fibrosis)

    Pulmonary CT changes during the study period

    Measured: Day 0 to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start30 Oct 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04780321
Sponsor's protocol ID
JS016-002-Ib/II
Status last verified
Jul 2022
First submitted
23 Sep 2020
Last updated
18 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg) in people with COVID-19, run by Shanghai Junshi Bioscience Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples) (time frame: 0-85days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04780321, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.

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