Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)
- Registration Number
- NCT04931238
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JS016 treatment group JS016 Standard therapy + JS016 injection Standard therapy including vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (4)
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
Li Weng
🇨🇳Beijing, Beijing, China