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Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04275245
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Brief Summary:
To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.

Condition or disease Intervention/treatment Phase
2019-nCoVs Infection Pneumonia Drug: Meplazumab for Injection Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Meplazumab
10mg Meplazumab by intravenous infusion, every day for 2 days
Drug: Meplazumab for Injection
humanized MAb against CD147




Primary Outcome Measures :
  1. 2019 nCoV nucleic acid detection [ Time Frame: 14 days ]
    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 :
  1. Recovery of body temperature [ Time Frame: 14 days ]
    Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)

  2. Recovery of resting respiratory rate [ Time Frame: 14 days ]
    Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)

  3. Recovery of SPO2 [ Time Frame: 14 days ]
    Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)

  4. Chest CT / chest film changes [ Time Frame: 28 days ]
    Rate of lung imaging recovery

  5. PaO2 / FiO2 [ Time Frame: 14 days ]
    Rate of PaO2 / FiO2 recovery

  6. Time to reach the isolation release standard [ Time Frame: 28 days ]
    Days to reach the isolation release standard

  7. Changes of inflammatory immune status [ Time Frame: 14 days ]
    Rate of CRP, D-Dimer test recovery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275245


Contacts
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Contact: Jianqi Lian, MD +86-13571892829 liangjq@fmmu.edu.cn
Contact: Huijie Bian, PhD +86-029-84774547 hjbian@fmmu.edu.cn

Locations
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China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Sicao Li    +86-029-84777631      
Sponsors and Collaborators
Tang-Du Hospital

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT04275245    
Other Study ID Numbers: 20200101
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections