Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JS016 treatment group 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. |
Drug: JS016
Single Intravenous Injection of JS016 with a dose of 50mg/kg
Other Names:
|
| No Intervention: Control group Standard therapy Standard therapy includes vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Li Weng | Beijing | Beijing | China | 100102 |
| 2 | Shi Jiazhuang People's Hospital | Shijia Zhuang | He Bei | China | |
| 3 | The First Affliated Hospital of Harbin Medical University | Harbin | Hei Longjiang | China | 0451 |
| 4 | Suihua first hospital | Suihua | Hei Longjiang | China | 0455 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Study Chair: Bin DU, Prof., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Peking JS016