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

Coronavirus Disease 2019 (COVID-19) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275245
• Other study ID #: 20200101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 3, 2020
• Est. completion date: March 9, 2020

Study information

• Verified date: April 2021
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019 (COVID-19)
• Pneumonia

Intervention

Drug:
• Meplazumab for Injection
humanized MAb against CD147

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recovery of body temperature	Time (days) from initiation of Meplazumab treatment until normalization of body temperature (=37? axilla)	14 days
Secondary	Recovery of resting respiratory rate	Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (=24/min)	14 days
Secondary	Recovery of SPO2	Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)	14 days
Secondary	Chest CT / chest film changes	Rate of lung imaging recovery	28 days
Secondary	PaO2 / FiO2	Rate of PaO2 / FiO2 recovery	14 days
Secondary	Time to reach the isolation release standard	Days to reach the isolation release standard	28 days
Secondary	Changes of inflammatory immune status	Rate of CRP, D-Dimer test recovery	14 days