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

NCT04931238 | Unknown Phase 2 DMC

• 1 other identifier: Peking JS016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19; SARS-CoV-2

Keywords

COVID-19; JS016; spike (S) protein; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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.

  At 28 days from inclusion

Secondary Outcomes (4)

• All cause mortality ascertained from data analysed to day 28

  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

  At 14 days from inclusion

• Average length of hospital stay

  At 28 days from inclusion

Other Outcomes (1)

• The incidence Treatment-Emergent Adverse Events of JS016

  Everyday after inclusion up to 28 days from inclusion

Study Arms (2)

JS016 treatment group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

JS016 DRUG

Single Intravenous Injection of JS016 with a dose of 50mg/kg

Also known as: CB6-LALA

JS016 treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (4)

Li Weng

Beijing, Beijing Municipality, 100102, China

RECRUITING

Shi Jiazhuang People's Hospital

Shijiazhuang, Hebei, China

RECRUITING

The First Affliated Hospital of Harbin Medical University

Harbin, Hei Longjiang, 0451, China

RECRUITING

Suihua first hospital

Suihua, Hei Longjiang, 0455, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 33215063 RESULT

• 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.

  PMID: 35713300 DERIVED

• 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.

  PMID: 35191746 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

etesevimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bin DU, Prof.

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Bin DU, Prof.

CONTACT

+86 13601366216; dubin98@gmail.com

Li Weng, Prof.

CONTACT

+86 18600017819; wengli@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 18, 2021
• Study Start: January 20, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)