Post-COVID-19Phase 3NCT05813587
To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19
A Phase 3 study testing Meplazumab for injection and Normal saline in people with Post-COVID-19, run by Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd at 1 site in China.
Trial summary
This trial was a randomized, double-blind, placebo-controlled, loading phase III clinical study. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Post-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
- 121 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2023to 26 Oct 2023
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This trial was a randomized, double-blind, placebo-controlled, loading phase III clinical study.
Read the 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.
- Conditions
- Post-COVID-19
- Being tested
- Meplazumab for injection, Normal saline
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
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Meplazumab | 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.
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)"
Measured: Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start23 Mar 2023
- Primary completion14 Sep 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-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
- 121 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
- NCT05813587
- Sponsor's protocol ID
- MPZ-III-02
- Status last verified
- Feb 2024
- First submitted
- 10 Apr 2023
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 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
- ClinicalTrials.gov ID
- NCT05813587
- Acronym / sponsor ID
- MPZ-III-02
- Conditions
- Post-COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Jiangsu Pacific Meinuoke Bio Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 14 Apr 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meplazumab | 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 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 | Meplazumab |
| Normal salineNormal saline | Other | Placebo |
Primary outcome
During the trial (28 days), the duration/degree of relief/recovery of four types of clinical symptoms of Post-COVID-19
Time frame: Day28
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)"
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.
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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 Post-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 5 inclusion and 17 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?
During the trial (28 days), the duration/degree of relief/recovery of four types of clinical symptoms of Post-COVID-19 (time frame: Day28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.