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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Antibodies; Antibodies, Monoclonal

Criteria

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