Back to resultsClinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
Primary Purpose
Coronavirus Disease 2019 (COVID-19)
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Meplazumab for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Disease 2019 (COVID-19) focused on measuring COVID-19, pneumonia
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Tangdu Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Meplazumab
Arm Description
10mg Meplazumab by intravenous infusion, every day for 2 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Recovery of body temperature
Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)
Recovery of resting respiratory rate
Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)
Recovery of SPO2
Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Chest CT / chest film changes
Rate of lung imaging recovery
PaO2 / FiO2
Rate of PaO2 / FiO2 recovery
Time to reach the isolation release standard
Days to reach the isolation release standard
Changes of inflammatory immune status
Rate of CRP, D-Dimer test recovery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04275245
Brief Title
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.
Detailed Description
According to the results of nonclinical study of humanized Meplazumab for Injection, a single dose will be used for the treatment. The treatment plan is first dose on the first day (0d) and second dose on the second day (1D) of the treatment period by intravenous(IV) infusion, each dose 10mg; The third dose will be given within 3-5 days after the second dose according to the patient's 2019-nCoV nucleic acid load, clinical manifestations and the overall evaluation of doctors, dose is 10mg. 30 mg of methylprednisolone will be given intravenously 30 minutes before each administration. Each subject will be evaluated the therapeutic effect within 28 days after the first administration, and to determine the preliminary therapeutic effect, safety and tolerability of humanized Meplazumab for Injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019 (COVID-19)
Keywords
COVID-19, pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meplazumab
Arm Type
Experimental
Arm Description
10mg Meplazumab by intravenous infusion, every day for 2 days
Intervention Type
Drug
Intervention Name(s)
Meplazumab for Injection
Intervention Description
humanized MAb against CD147
Primary Outcome Measure Information:
Title
2019 nCoV nucleic acid detection
Description
Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Recovery of body temperature
Description
Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)
Time Frame
14 days
Title
Recovery of resting respiratory rate
Description
Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)
Time Frame
14 days
Title
Recovery of SPO2
Description
Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Time Frame
14 days
Title
Chest CT / chest film changes
Description
Rate of lung imaging recovery
Time Frame
28 days
Title
PaO2 / FiO2
Description
Rate of PaO2 / FiO2 recovery
Time Frame
14 days
Title
Time to reach the isolation release standard
Description
Days to reach the isolation release standard
Time Frame
28 days
Title
Changes of inflammatory immune status
Description
Rate of CRP, D-Dimer test recovery
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Facility Information:
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34473343
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia
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