Coronavirus Disease 2019 (COVID-19)
Conditions
Keywords
COVID-19, pneumonia
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.
Interventions
humanized MAb against CD147
Sponsors
Tang-Du Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2019 nCoV nucleic acid detection | 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
| Measure | Time frame | Description |
|---|---|---|
| Recovery of resting respiratory rate | 14 days | Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min) |
| Recovery of SPO2 | 14 days | Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (\>94%) |
| Chest CT / chest film changes | 28 days | Rate of lung imaging recovery |
| Recovery of body temperature | 14 days | Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla) |
| Time to reach the isolation release standard | 28 days | Days to reach the isolation release standard |
| Changes of inflammatory immune status | 14 days | Rate of CRP, D-Dimer test recovery |
| PaO2 / FiO2 | 14 days | Rate of PaO2 / FiO2 recovery |
Countries
China
Outcome results
None listed