Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
Single Center, Single Arm, Open Clinical Study to Access Safety and Initial Efficacy of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
1 other identifier
interventional
17
1 country
1
Brief Summary
To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2020
CompletedFirst Submitted
Initial submission to the registry
February 6, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2020
CompletedApril 9, 2021
April 1, 2021
1 month
February 6, 2020
April 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2019 nCoV nucleic acid detection
Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively.
14 days
Secondary Outcomes (7)
Recovery of body temperature
14 days
Recovery of resting respiratory rate
14 days
Recovery of SPO2
14 days
Chest CT / chest film changes
28 days
PaO2 / FiO2
14 days
- +2 more secondary outcomes
Study Arms (1)
Meplazumab
EXPERIMENTAL10mg Meplazumab by intravenous infusion, every day for 2 days
Interventions
Eligibility Criteria
You may qualify if:
- Men and women aged 18 to 75 years (inclusive)
- In line with the new coronavirus infection pneumonia diagnosis and treatment plan (trial version 4) issued by the Health Commission, patients with new coronavirus (2019 ncov) pneumonia were clinically diagnosed;
- The subjects must be able to understand the study and willing to participate in the study, and sign the informed consent (if the subjects with no behavioral ability think it is in their own interests to participate in the test, they should sign the informed consent by their legal guardian, or notify the consent by phone (recording) and explain it in the original medical record and other relevant documents).
You may not qualify if:
- Known or expected to have allergic reactions or a history of allergy to any of the ingredients treated in this trial;
- In the judgment of the investigator, there are other reasons that the patient is not suitable to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tang-Du Hospitallead
Study Sites (1)
Tangdu Hospital
Xi'an, Shaanxi, 710032, China
Related Publications (1)
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PMID: 34473343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2020
First Posted
February 19, 2020
Study Start
February 3, 2020
Primary Completion
March 9, 2020
Study Completion
March 9, 2020
Last Updated
April 9, 2021
Record last verified: 2021-04