Clinical trial NCT04931238: Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
SARS-CoV-2
Keywords: COVID-19
JS016
spike (S) protein
SARS-CoV-2
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical status at 28 days
timeFrame: At 28 days from inclusion
Secondary outcomes:
measure: All cause mortality ascertained from data analysed to day 28
timeFrame: At 28 days from inclusion
measure: Ventilator-free days within 28 days
timeFrame: At 28 days from inclusion
measure: Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization
timeFrame: At 14 days from inclusion
measure: Average length of hospital stay
timeFrame: At 28 days from inclusion
Other outcomes:
measure: The incidence Treatment-Emergent Adverse Events of JS016
timeFrame: Everyday after inclusion up to 28 days from inclusion
Locations:
city: Beijing
country: China
facility: Li Weng
state: Beijing
city: Shijia Zhuang
country: China
facility: Shi Jiazhuang People's Hospital
state: He Bei
city: Harbin
country: China
facility: The First Affliated Hospital of Harbin Medical University
state: Hei Longjiang
city: Suihua
country: China
facility: Suihua first hospital
state: Hei Longjiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Bin DU, Prof.
role: STUDY_CHAIR
References:
citation: Yang L, Liu W, Yu X, Wu M, Reichert JM, Ho M. COVID-19 antibody therapeutics tracker: a global online database of antibody therapeutics for the prevention and treatment of COVID-19. Antib Ther. 2020 Jul;3(3):205-212. doi: 10.1093/abt/tbaa020. Epub 2020 Aug 19.
citation: Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
citation: Dong R, Jiang L, Yang T, Wang C, Zhang Y, Chen X, Xie J, Guo Y, Weng L, Kang Y, Yu K, Qiu H, Du B; China Critical Care Clinical Trials Group (CCCCTG). Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody JS016 in Hospitalized Chinese Patients with COVID-19: a Phase 2/3, Multicenter, Randomized, Open-Label, Controlled Trial. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0204521. doi: 10.1128/AAC.02045-21. Epub 2022 Mar 15.