Clinical trial NCT05113784: the Safety and Efficacy of Meplazumab in Patients With COVID-19
Official title: A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Lead sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, double-blind, randomized, placebo-controlled phase 2/3 clinical study. Based on the results of the Phase I clinical study, one repeat dose group and one placebo group are used for the standard treatment of the Novel Coronavirus Pneumonia Protocol (Trial 8) The treatment regimen is a one-time intravenous infusion of either mprozumab or placebo on day 1 (D1) and day 8 (D8) of the treatment period at a dose of 0.2 mg/kg based on body weight. An estimated 150 subjects will be randomly assigned to either Meplazumab or placebo in a 2:1 ratio A short-term efficacy evaluation was performed to determine the efficacy and safety of Meplazumab in each subject within 14 days of initial administration and a long-term follow-up evaluation was performed 28 days after initial administration to determine the safety of Meplazumab.


Eligibility criteria: Inclusion Criteria:

* 18 years ≤Subject ≤ 75 years, Male and/or female;
* Clinical confirmation of COVID-19 patients in accordance with novel Coronavirus Diagnosis and Treatment Protocol (Trial Version 8) of the NHC
* Participants must be able to understand and willing to participate in this research, this study and signed informed consent form (if incapacitated subjects, the researchers believe the subjects to the test in its own interests, should be signed by its legal guardian informed consent, or telephone inform consent (recording) and note it in the original medical records and other relevant documents)

Exclusion Criteria:

* Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent;
* SARS-CoV-2 infection by PCR ≥ 96h;
* Platelet (PLT) \< 50×10\^9/L, or hemoglobin (HGB) \< 60g/L;
* Total bilirubin (TBIL) \> 2×ULN (upper limit of normal value), or alanine transferase (ALT), aspartate transferase (AST), alkaline phosphatase (ALP) \> 5×ULN;
* glomerular filtration rate (GFR) \< 30mL/min·1.73m\^2, or serum creatinine increased by 0.5mg/ dL within 7 days, or oliguria (\<400mL/24hr), or anuria (\<100mL/24hr);
* Pregnant or breast feeding;
* Persons who have family planning or do not agree to use effective non-drug contraceptive measures within 6 months after signing the ICF;
* Subjects participating in another clinical study. There will be a need for washout with 5 half lives depending on the study treatment or 30 days since any previous study, whichever is longer;
* he inestigators concluded that the patients had other reasons for not being eligible for the study.

Primary outcomes:
measure: Time of virus nucleic acid test turning negative
timeFrame: up to 14 days
Secondary outcomes:
measure: Treatment to discharge time
timeFrame: up to 28 days
measure: Evolution of the imaging parameters
timeFrame: up to day28
measure: Assessment of the immune response profile
timeFrame: up to day28
measure: Assessment of the biochemistry profile
timeFrame: up to day28
measure: Assessment of the cytokines profile
timeFrame: up to day28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Shenzhen
country: China
facility: The Third People's Hospital Of Shenzhen
Study officials:
affiliation: Shenzhen Third People's Hospital
name: Hongzhou Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Public Health Clinical Center
name: Yinzhong Shen
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Third People's Hospital
name: Yingxia Liu
role: PRINCIPAL_INVESTIGATOR
References: