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.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)
