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

NCT04931238 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

JS016

Single Intravenous Injection of JS016 with a dose of 50mg/kg

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Bin DU, Prof. · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04931238 on ClinicalTrials.gov