COVID-19Phase 3NCT05679479
Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19
A Phase 3 study testing Meplazumab for injection and Normal saline in people with COVID-19, run by Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd at 1 site in China.
Trial summary
This is a multicenter, double-blind, randomized, placebo-controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of the standard treatments according to the results of clinical studies have been obtained… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Meplazumab for injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2024to 18 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, male or female;
- Patients with clinically confirmed 2019-ncov infection (severe) in accordance with the National Health Commission's "Diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10)";;
- Agree to use a highly effective non-pharmacologic contraceptive method within 3 months after signing ICF to the end of the trial;
- Subjects must be able to understand the study and willing to participate in the study, and sign an informed consent form (if the researcher believes that it is in the interests of the subjects to participate in the study, the informed consent form should be signed by the legal guardian of the subjects and explained in the original medical records and other relevant documents).
Who cannot join
- Any physical examination results, laboratory abnormalities and/or any medical history of the subject may, in the investigator's judgment, endanger the subject's safety by participating in the study;
- Use of an anti-coronavirus treatment such as Paxlovid (nematavir/ritonavir combination package) within 3 half-lives before the first dose or during the study period, About 6.05 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), senotevir tablets/ritonavir tablets The combination package (t1/2 about 4.14 h), baritinib (t1/2 about 12.5 h), tocilizumab (t1/2 about 21.5 days), remdesivir (t1/2 about 27 h), lenreterivir (t1/2 about 14.9 h), favelavir (t1/2 about 4.5 h) h), 2-deoxy-D-glucose (t1/2 about 50 min), etc.
- Critically ill patients with clinically confirmed 2019-ncov infection according to the Diagnosis and Treatment Protocol for 2019 novel Coronavirus Infection (Trial version 10) issued by the National Health Commission of the People's Republic of China;
- Stage 4 severe chronic kidney disease requiring dialysis (i.e., estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2), an increase in serum creatinine of 44.2 μmol/L within 7 days, oliguria (< 400 mL/24 hours) or anuria (< 100 mL/24 hours);
- During pregnancy or lactation;
- They will be transferred to another hospital other than the study site within 72 hours;
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- Known to be allergic to the test drug and its components;
- No live vaccine (live attenuated vaccine) was administered within 2 weeks before randomization or during study treatment and safety follow-up;
- Subjects participating in another clinical study at the same time. A washout period of 5 half-lives is required (depending on the study drug or 30 days from any previous study, whichever is longer);
- Total bilirubin (TBL) > 2× upper limit of normal (ULN), alanine aminotransferase (ALT) > 5×ULN, aspartate aminotransferase (AST) > 5×ULN, or alkaline phosphatase > 5×ULN;
- Platelet count < 50×109/L or hemoglobin < 70 g/L;
- Other factors that the investigator deemed inappropriate for trial entry.
- Note: researchers should ensure that participants when screening meets all inclusion/exclusion standard. If a subject's status changes (including laboratory results) between screening and initial dosing and if the subject meets one of the exclusion criteria, the subject shall be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Loaded Phase III Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19
This is a multicenter, double-blind, randomized, placebo-controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of the standard treatments according to the results of clinical studies have been obtained, using a dose of 0.2 mg/kg, and a placebo. The regimen consisted of a single intravenous infusion of Meplazumab or placebo on day 1 (d0) of the treatment period and d7 after initial administration at a dose of 0.2 mg/kg calculated according to body weight. It is expected that 350 subjects will be randomly assigned to Meplazumab or placebo in a 1:1 ratio. Short-term efficacy evaluation was performed for each subject within 28 days after initial administration to determine the therapeutic efficacy and safety of Meplazumab. Long-term follow-up evaluation was performed within 56 days of initial administration to determine the safety of Meplazumab in each subject.
- Conditions
- COVID-19
- Being tested
- Meplazumab for injection, Normal saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meplazumab for injectionBiological
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.
Normal salineOther
0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Meplzaumb | Experimental | First dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8 Receives: Biological: Meplazumab for injection |
| Placebo | Placebo comparator | First dose: control - Day 1; second dose: control - Day 8 Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality at day 28 (d28)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start19 Jan 2024
- Primary completion30 Jan 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679479
- Sponsor's protocol ID
- MPZ-III-01-CN
- Status last verified
- May 2024
- First submitted
- 10 Jan 2023
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bian H, Chen L, Zhang Z, Wen AD, Zheng ZH, Song LQ, Yao MY, Liu YX, Zhang XJ, Dong HL, Lian JQ, Pan L, Liu Y, Gu X, Zhao H, Wang JW, Wang QY, Zhang K, Jia JF, Xie RH, Luo X, Fu XH, Jia YY, Hou JN, Tan QY, Chen XX, Yang LQ, Lin YL, Wang XX, Zhang L, Zeng QJ, Li WJ, Wang RX, Zhang Y, Sun XX, Wang B, Yang X, Jiang JL, Li L, Wu J, Yang XM, Zhang H, Shi Y, Chen XC, Tang H, Shi HW, Liu SS, Yang Y, Yang TY, Wei D, Chen ZN, Zhu P. Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial. Signal Transduct Target Ther. 2025 Apr 14;10(1):119. doi: 10.1038/s41392-025-02208-9.
PubMed 40222976
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled, Loaded Phase III Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05679479
- Acronym / sponsor ID
- MPZ-III-01-CN
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Jiangsu Pacific Meinuoke Bio Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, double-blind, randomized, placebo-controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of the standard treatments according to the results of clinical studies have been obtained, using a dose of 0.2 mg/kg, and a placebo. The regimen consisted of a single intravenous infusion of Meplazumab or placebo on day 1 (d0) of the treatment period and d7 after initial administration at a dose of 0.2 mg/kg calculated according to body weight. It is expected that 350 subjects will be randomly assigned to Meplazumab or placebo in a 1:1 ratio. Short-term efficacy evaluation was performed for each subject within 28 days after initial administration to determine the therapeutic efficacy and safety of Meplazumab. Long-term follow-up evaluation was performed within 56 days of initial administration to determine the safety of Meplazumab in each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meplzaumb | Experimental | Biological: Meplazumab for injectionFirst dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8 |
| Placebo | Placebo comparator | Other: Normal salineFirst dose: control - Day 1; second dose: control - Day 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old, male or female;
- Patients with clinically confirmed 2019-ncov infection (severe) in accordance with the National Health Commission's "Diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10)";;
- Agree to use a highly effective non-pharmacologic contraceptive method within 3 months after signing ICF to the end of the trial;
- Subjects must be able to understand the study and willing to participate in the study, and sign an informed consent form (if the researcher believes that it is in the interests of the subjects to participate in the study, the informed consent form should be signed by the legal guardian of the subjects and explained in the original medical records and other relevant documents).
Key exclusion criteria (13 listed)
- Any physical examination results, laboratory abnormalities and/or any medical history of the subject may, in the investigator's judgment, endanger the subject's safety by participating in the study;
- Use of an anti-coronavirus treatment such as Paxlovid (nematavir/ritonavir combination package) within 3 half-lives before the first dose or during the study period, About 6.05 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), senotevir tablets/ritonavir tablets The combination package (t1/2 about 4.14 h), baritinib (t1/2 about 12.5 h), tocilizumab (t1/2 about 21.5 days), remdesivir (t1/2 about 27 h), lenreterivir (t1/2 about 14.9 h), favelavir (t1/2 about 4.5 h) h), 2-deoxy-D-glucose (t1/2 about 50 min), etc.
- Critically ill patients with clinically confirmed 2019-ncov infection according to the Diagnosis and Treatment Protocol for 2019 novel Coronavirus Infection (Trial version 10) issued by the National Health Commission of the People's Republic of China;
- Stage 4 severe chronic kidney disease requiring dialysis (i.e., estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2), an increase in serum creatinine of 44.2 μmol/L within 7 days, oliguria (< 400 mL/24 hours) or anuria (< 100 mL/24 hours);
- During pregnancy or lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meplazumab for injectionMeplazumab 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. | Biological | Meplzaumb |
| Normal saline0.9% normal saline | Other | Placebo |
Primary outcome
Mortality
Time frame: Day 28
All-cause mortality at day 28 (d28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 40222976Bian H, Chen L, Zhang Z, Wen AD, Zheng ZH, Song LQ, Yao MY, Liu YX, Zhang XJ, Dong HL, Lian JQ, Pan L, Liu Y, Gu X, Zhao H, Wang JW, Wang QY, Zhang K, Jia JF, Xie RH, Luo X, Fu XH, Jia YY, Hou JN, Tan QY, Chen XX, Yang LQ, Lin YL, Wang XX, Zhang L, Zeng QJ, Li WJ, Wang RX, Zhang Y, Sun XX, Wang B, Yang X, Jiang JL, Li L, Wu J, Yang XM, Zhang H, Shi Y, Chen XC, Tang H, Shi HW, Liu SS, Yang Y, Yang TY, Wei D, Chen ZN, Zhu P. Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial. Signal Transduct Target Ther. 2025 Apr 14;10(1):119. doi: 10.1038/s41392-025-02208-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meplazumab for injection and Normal saline in people with COVID-19, run by Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05679479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.