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To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19

Primary Purpose

Post-COVID-19

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Meplazumab for injection
Normal saline
Sponsored by
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 84 (including 18 and 84), male and female Patients had been infected with 2019-ncov and had at least one symptom of Post-COVID-19 after infection, such as insomnia, memory loss, smell change, taste change, fatigue or fatigue, headache, chest pain, muscle/joint pain, shortness of breath, cough, palpitation, arrhythmia, and aggravation of the primary disease According to the Post-COVID-19 Clinical symptom assessment form , the total symptom assessment score of the subjects was ≥2 before randomization Agree to use highly effective birth control within 3 months of using the experimental drug The subjects were able to communicate well with the investigators, understand and comply with the requirements of the study, and understand and sign the informed consent Exclusion Criteria: 1. Patients with allergic constitution and known allergic to the test drug and its components 2. Patients who underwent surgery or chemotherapy or radiotherapy within 28 days before screening 3. Patients had a serious systemic disease, condition, or disorder, etc., that was deemed by the investigator to be inappropriate for participation in the study 4. Use of an anti-coronavirus treatment such as Paxlovid (nematavir/ritonavir packaged in combination) within three half-lives before the first dose or during the study period, About 18 h at t1/2), Azvudine tablets (about 9 h at t1/2), and monolavir capsules (about 3.3 h at t1/2) h), ambavirumab/romisivir injection (t1/2 about 45 days /75 days), COVID-19 human immunoglobulin (t1/2 about 3-4 weeks) or recovery plasma (t1/2 about 21 days), deuremidvir hydrobromide tablets (t1/2 about 4.80-6.95 hours), etc 5. At the time of screening, any of the laboratory test indicators meet the following criteria ALT or AST >3ULN Total bilirubin ≥2 ULN White blood cell count > 2 ULN Neutrophil absolute value<0.5×109/L Platelet count < 80×109/L eGFR <60 mL/min/1.73 m2 (calculated by CKD-EPI formula) Note: For patients with connective tissue diseases such as systemic lupus erythematosus, Sjogren's syndrome, and inflammatory myopathy, including but not limited to the above three diseases, the value of this index was determined by the investigator 6. Weight ≤40 kg 7. Dizzy with needles and blood 8. Had participated in other drug clinical trials within 3 months before screening 9. Pregnant, lactating women or those with a positive pregnancy 10. Other factors that the investigators considered inappropriate for trial entry

Sites / Locations

  • First Affiliated Hospital of the Air Force Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Meplazumab

Placebo

Arm Description

First dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8

First dose: control - Day 1; second dose: control - Day 8

Outcomes

Primary Outcome Measures

During the trial (28 days), the duration/degree of relief/recovery of four types of clinical symptoms of Post-COVID-19
The clinical symptoms of Post-COVID-19 mainly involved the nervous system and physical ability (insomnia, memory loss, olfactory changes, taste changes, fatigue or fatigue, headache, chest pain, muscle/joint pain), respiratory system (shortness of breath, cough), cardiovascular system (palpitation, arrhythmia), and aggravation of primary diseases. Clinical symptoms/restore definition: new crown sequela comprehensive score decline, and continue for at least 2 days. Patients with the above symptoms were evaluated according to the actual clinical symptoms, and the clinical symptoms that did not appear were evaluated as "0 (none)"

Secondary Outcome Measures

Full Information

First Posted
April 10, 2023
Last Updated
September 14, 2023
Sponsor
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05813587
Brief Title
To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19
Official Title
A Randomized, Double-blind, Placebo-controlled, Loaded Phase III Clinical Trial on the Efficacy and Safety of Mepozumab for Injection in the Treatment of Post-COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
September 7, 2023 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This trial was a randomized, double-blind, placebo-controlled, loading phase III clinical study.
Detailed Description
This test is in the new type of coronavirus infection therapy and 10 (trial version) "and" new coronavirus pneumonia antiviral drug clinical trial technical guidelines (try out) ", on the basis of according to the results of the phase I and phase II clinical study to set up an experimental group and a placebo group, experimental group on the basis of medicines for load test, The control group was loaded with placebo as the base treatment. A planned cohort of 144 patients with Post-COVID-19 (120 +20% dropped out) was randomly assigned in a 1:1 ratio to the experimental group or the placebo group. Mepozumab or placebo was intravenously infused at a dose of 0.2 mg/kg on day 1 (D0). If the clinical symptoms of Post-COVID-19 were not relieved (remission was defined as a decrease in the Post-COVID-19 composite score for at least 2 days), an additional dose of 0.2 mg/kg was administered on day 7 after the first dose, and the actual dose was calculated according to the body weight of the subject. The participants were asked to record the clinical symptoms of Post-COVID-19 daily during the trial. The absent clinical symptoms were evaluated as "zero (none)", and the present clinical symptoms were recorded until they returned to normal (score: zero), which lasted for at least 2 days. On the 28th day (D28±3) after the first dose, the subjects were required to return to the study center again, return their diary cards, and complete each exit examination. If a participant stops the trial early for various reasons, laboratory testing is required to complete the efficacy and safety assessment. During the trial, the subjects were treated according to the type and severity of adverse events according to the clinical diagnosis and treatment standards.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meplazumab
Arm Type
Experimental
Arm Description
First dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
First dose: control - Day 1; second dose: control - Day 8
Intervention Type
Biological
Intervention Name(s)
Meplazumab for injection
Intervention Description
Meplazumab is a humanized anti-CD147 immunoglobulin 2 (IgG2) monoclonal antibody which is expected to block the binding of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human host-cell-expressed CD147, thereby blocking entry of SARS-CoV-2 into human tissue. This expectation is based on in vitro functional studies using Vero E6 cells infected with SARS-CoV-2 that demonstrated effective meplazumab mediated virus gene copy number inhibition upwards of 90% as evaluated by quantitative polymerase chain reaction. Meplazumab may also inhibit COVID-19 associated cytokine storm syndrome based on inhibition of the pro inflammatory factor Cyclophilin A host-cell CD147 interaction.
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
During the trial (28 days), the duration/degree of relief/recovery of four types of clinical symptoms of Post-COVID-19
Description
The clinical symptoms of Post-COVID-19 mainly involved the nervous system and physical ability (insomnia, memory loss, olfactory changes, taste changes, fatigue or fatigue, headache, chest pain, muscle/joint pain), respiratory system (shortness of breath, cough), cardiovascular system (palpitation, arrhythmia), and aggravation of primary diseases. Clinical symptoms/restore definition: new crown sequela comprehensive score decline, and continue for at least 2 days. Patients with the above symptoms were evaluated according to the actual clinical symptoms, and the clinical symptoms that did not appear were evaluated as "0 (none)"
Time Frame
Day28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 84 (including 18 and 84), male and female Patients had been infected with 2019-ncov and had at least one symptom of Post-COVID-19 after infection, such as insomnia, memory loss, smell change, taste change, fatigue or fatigue, headache, chest pain, muscle/joint pain, shortness of breath, cough, palpitation, arrhythmia, and aggravation of the primary disease According to the Post-COVID-19 Clinical symptom assessment form , the total symptom assessment score of the subjects was ≥2 before randomization Agree to use highly effective birth control within 3 months of using the experimental drug The subjects were able to communicate well with the investigators, understand and comply with the requirements of the study, and understand and sign the informed consent Exclusion Criteria: 1. Patients with allergic constitution and known allergic to the test drug and its components 2. Patients who underwent surgery or chemotherapy or radiotherapy within 28 days before screening 3. Patients had a serious systemic disease, condition, or disorder, etc., that was deemed by the investigator to be inappropriate for participation in the study 4. Use of an anti-coronavirus treatment such as Paxlovid (nematavir/ritonavir packaged in combination) within three half-lives before the first dose or during the study period, About 18 h at t1/2), Azvudine tablets (about 9 h at t1/2), and monolavir capsules (about 3.3 h at t1/2) h), ambavirumab/romisivir injection (t1/2 about 45 days /75 days), COVID-19 human immunoglobulin (t1/2 about 3-4 weeks) or recovery plasma (t1/2 about 21 days), deuremidvir hydrobromide tablets (t1/2 about 4.80-6.95 hours), etc 5. At the time of screening, any of the laboratory test indicators meet the following criteria ALT or AST >3ULN Total bilirubin ≥2 ULN White blood cell count > 2 ULN Neutrophil absolute value<0.5×109/L Platelet count < 80×109/L eGFR <60 mL/min/1.73 m2 (calculated by CKD-EPI formula) Note: For patients with connective tissue diseases such as systemic lupus erythematosus, Sjogren's syndrome, and inflammatory myopathy, including but not limited to the above three diseases, the value of this index was determined by the investigator 6. Weight ≤40 kg 7. Dizzy with needles and blood 8. Had participated in other drug clinical trials within 3 months before screening 9. Pregnant, lactating women or those with a positive pregnancy 10. Other factors that the investigators considered inappropriate for trial entry
Facility Information:
Facility Name
First Affiliated Hospital of the Air Force Medical University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuangshuang Liu
Phone
+86 15061133961
Email
lss@pmbp.cn

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19

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