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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: COVID-19; SARS-CoV-2

Treatments: Drug: JS016

Study type: Interventional

Funder types: Other

Identifiers

NCT04931238

Peking JS016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

JS016 treatment group

Experimental group

Description:

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.

Treatment:

Drug: JS016

Control group

No Intervention group

Description:

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