Clinical trial NCT04275245: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronavirus Disease 2019 (COVID-19)
Keywords: COVID-19, pneumonia
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 2019 nCoV nucleic acid detection
timeFrame: 14 days
Secondary outcomes:
measure: Recovery of body temperature
timeFrame: 14 days
measure: Recovery of resting respiratory rate
timeFrame: 14 days
measure: Recovery of SPO2
timeFrame: 14 days
measure: Chest CT / chest film changes
timeFrame: 28 days
measure: PaO2 / FiO2
timeFrame: 14 days
measure: Time to reach the isolation release standard
timeFrame: 28 days
measure: Changes of inflammatory immune status
timeFrame: 14 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
References:
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.