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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Li Weng
Beijing, Beijing Municipality, China
RECRUITINGShi Jiazhuang People's Hospital
Shijiazhuang, Hebei, China
RECRUITINGThe First Affliated Hospital of Harbin Medical University
Harbin, Hei Longjiang, China
RECRUITINGClinical 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.
Time frame: At 28 days from inclusion
All cause mortality ascertained from data analysed to day 28
All cause mortality ascertained from data analysed to day 28
Time frame: At 28 days from inclusion
Ventilator-free days within 28 days
Ventilator-free days within 28 days
Time frame: At 28 days from inclusion
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
Time frame: At 14 days from inclusion
Average length of hospital stay
Average length of hospital stay
Time frame: At 28 days from inclusion
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Suihua first hospital
Suihua, Hei Longjiang, China
RECRUITING