Tangdu Hospital
Xi'an, Shaanxi, 710032, China
NCT Number: NCT04275245
To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Xi'an, Shaanxi, 710032, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
humanized MAb against CD147
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.
Time frame: 14 days
Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)
Time frame: 14 days
Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)
Time frame: 14 days
Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%)
Time frame: 28 days
Rate of lung imaging recovery
Time frame: 14 days
Rate of PaO2 / FiO2 recovery
Time frame: 28 days
Days to reach the isolation release standard
Time frame: 14 days
Rate of CRP, D-Dimer test recovery
Tang-Du Hospital
Other
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
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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