COVID-19, SARS-CoV-2
Conditions
Keywords
COVID-19, JS016, spike (S) protein, SARS-CoV-2
Brief 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.
Detailed 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.
Interventions
DRUGJS016
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical status at 28 days | At 28 days from inclusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality ascertained from data analysed to day 28 | At 28 days from inclusion | All cause mortality ascertained from data analysed to day 28 |
| Ventilator-free days within 28 days | At 28 days from inclusion | Ventilator-free days within 28 days |
| Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization | At 14 days from inclusion | Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after |
| Average length of hospital stay | At 28 days from inclusion | Average length of hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| The incidence Treatment-Emergent Adverse Events of JS016 | Everyday after inclusion up to 28 days from inclusion | Incidence of Treatment-Emergent Adverse Events of JS016 includes the incidence of allergic reaction, secondary infection, liver dysfunction, acute kidney injury. |
Countries
China
Contacts
Primary ContactBin DU, Prof.
Backup ContactLi Weng, Prof.
Outcome results
None listed