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Completed

NCT Number: NCT04275245

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tangdu Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

meplazumab for injection

Drug

humanized MAb against CD147

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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