- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05813587
To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Xi'an, China
- First Affiliated Hospital of the Air Force Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
First dose: control - Day 1; second dose: control - Day 8
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Normal saline
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Experimental: Meplazumab
First dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
During the trial (28 days), the duration/degree of relief/recovery of four types of clinical symptoms of Post-COVID-19
Time Frame: Day28
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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)"
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Day28
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPZ-III-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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