Covid19Phase 2/3NCT05113784

the Safety and Efficacy of Meplazumab in Patients With COVID-19

A Phase 2/3 study testing Meplazumab for Injection and Sterile normal saline (0.9%) in people with Covid19, run by Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Covid19
What is being tested?: Meplazumab for Injection and Sterile normal saline (0.9%)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 2 sitesChina
Study dates: 21 Jan 2022to 8 Oct 2022
Phase: Phase 2/3
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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;

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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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
The Third People's Hospital Of Shenzhen
Shenzhen

Other trials in China

About this study

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

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.

Conditions: Covid19
Being tested: Meplazumab for Injection, Sterile normal saline (0.9%)
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 InjectionDrug
humanized antibody target CD147
Sterile normal saline (0.9%)Drug
Sterile normal saline (0.9%)

Study groups in NCT05113784
Study group	Role	What they receive
Meplazumab for Injection	Experimental	First dose: 0.2 mg/kg - Day 1; Second dose: 0.2 mg/kg - Day 8 Receives: Drug: Meplazumab for Injection
Placebo	Placebo comparator	First dose: control - Day 1; Second dose: control -Day 8 Receives: Drug: Sterile normal saline (0.9%)

What is being measured

The primary outcome is the main question the study is designed to answer.

Time of virus nucleic acid test turning negative
Time of virus nucleic acid test turning negative
Measured: up to 14 days

Secondary outcomes (5)

Treatment to discharge time
Treatment to discharge time
Measured: up to 28 days
Evolution of the imaging parameters
Changes from pre-dose baseline in CT
Measured: up to day28
Assessment of the immune response profile
Immune response profile characterized according immune cells and subsets and CRP.
Measured: up to day28
Assessment of the biochemistry profile
Change from pre-dose baseline in blood biochemistry:Fbg,Cr,BUN,UA,AST,ALT,g-GT,TBIL,ALB,TP,NA,K,Ca,CL
Measured: up to day28
Assessment of the cytokines profile
Change from pre-dose baseline in cytokines:IL-1b、IL-6、IL-8、IL-10、IL-17、CCL2、CXCL-1、CXCL-2、IFN-γ、TNFα、CyPA
Measured: up to day28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 20228 Oct 2022

First posted9 Nov 2021
Study start21 Jan 2022
Primary completion20 Sep 2022
Study completion8 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05113784
Sponsor's protocol ID: MPZ-II-01-CN
Status last verified: Mar 2022
First submitted: 17 Sep 2021
Last updated: 15 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05113784
Acronym / sponsor ID: MPZ-II-01-CN
Conditions: Covid19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
Study start: 21 Jan 2022 (actual)
Primary completion: 20 Sep 2022 (actual)
Study completion: 8 Oct 2022 (actual)
First posted: 9 Nov 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Meplazumab for Injection	Experimental	Drug: Meplazumab for InjectionFirst dose: 0.2 mg/kg - Day 1; Second dose: 0.2 mg/kg - Day 8
Placebo	Placebo comparator	Drug: Sterile normal saline (0.9%)First dose: control - Day 1; Second dose: control -Day 8

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (9 listed)

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);

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 Injectionhumanized antibody target CD147	Drug	Meplazumab for Injection
Sterile normal saline (0.9%)Sterile normal saline (0.9%)	Drug	Placebo

Primary outcome

Time of virus nucleic acid test turning negative
Time frame: up to 14 days
Time of virus nucleic acid test turning negative

5 secondary outcomes

Treatment to discharge time
Time frame: up to 28 days
Evolution of the imaging parameters
Time frame: up to day28
Assessment of the immune response profile
Time frame: up to day28
Assessment of the biochemistry profile
Time frame: up to day28
Assessment of the cytokines profile
Time frame: up to day28

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 15 Sep 2023.

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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.

Hongzhou Lu principal investigator

Shenzhen Third People's Hospital

Yinzhong Shen principal investigator

Shanghai Public Health Clinical Center

Yingxia Liu principal investigator

Shenzhen Third People's Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Meplazumab for Injection and Sterile normal saline (0.9%) in people with Covid19, run by Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd at 2 sites 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 3 inclusion and 9 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Time of virus nucleic acid test turning negative (time frame: up to 14 days). 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 NCT05113784.

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 15 Sep 2023.