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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931238
• Other study ID #: Peking JS016
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Peking Union Medical College Hospital
• Contact: Bin DU, Prof.
• Phone: +86 13601366216
• Email: dubin98[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
China	Li Weng	Beijing	Beijing
China	The First Affliated Hospital of Harbin Medical University	Harbin	Hei Longjiang
China	Shi Jiazhuang People's Hospital	Shijia Zhuang	He Bei
China	Suihua first hospital	Suihua	Hei Longjiang

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Au — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence Treatment-Emergent Adverse Events of JS016	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
Primary	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	All cause mortality ascertained from data analysed to day 28	All cause mortality ascertained from data analysed to day 28	At 28 days from inclusion
Secondary	Ventilator-free days within 28 days	Ventilator-free days within 28 days	At 28 days from inclusion
Secondary	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	At 14 days from inclusion
Secondary	Average length of hospital stay	Average length of hospital stay	At 28 days from inclusion