Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of a Recombinant Neutralizing Human Anti-SARS-CoV-2 Monoclonal Antibody JS016 in Chinese Hospitalized Patients With SARS-CoV-2 Infection (COVID-19): a Multicenter, Randomized, Open-label, Controlled Trial

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Drug: JS016


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JS016 treatment group<br>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<br>* Single Intravenous Injection of JS016 with a dose of 50mg/kg<br>* Other names: CB6-LALA;|
| No Intervention: Control group<br>Standard therapy Standard therapy includes vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical 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. | At 28 days from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality ascertained from data analysed to day 28 | All cause mortality ascertained from data analysed to day 28 | At 28 days from inclusion | 
| Ventilator-free days within 28 days | Ventilator-free days within 28 days | 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 | At 14 days from inclusion | 
| Average length of hospital stay | Average length of hospital stay | At 28 days from inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, JS016, spike (S) protein, SARS-CoV-2