The human monoclonal antibody CB6 showed potent neutralization activity in vitro againstSARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase Itrials among healthy volunteers has demonstrated a tolerable and safe drug profile ofJS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized withCOVID-19.
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.
Drug: JS016
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Other Name: CB6-LALA
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
Li Weng
Beijing, Beijing, China
Shi Jiazhuang People's Hospital
Shijia Zhuang, He Bei, China
The First Affliated Hospital of Harbin Medical University
Harbin, Hei Longjiang, China
Suihua first hospital
Suihua, Hei Longjiang, China
Bin DU, Prof.
+86 13601366216
dubin98@gmail.com
Li Weng, Prof.
+86 18600017819
wengli@gmail.com
Bin DU, Prof., Study Chair
Peking Union Medical College Hospital