COVID-19Phase 3NCT05679492
Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19
A Phase 3 study testing Meplazumab foe 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, randomized, double-blind, placebo-controlled, add-on Phase III clinical study. Based on the "Diagnosis and Treatment Protocol for COVID-19 Pneumonia (Trial 10th edition)" and according to the results of phase I and Phase II clinical studies, one dose group and one placebo group were used in this… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Meplazumab foe 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 1 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 18 to 80 (including 18 and 80 years old), male or female
- The subject tested positive for SARS-CoV-2 by nucleic acid test within 96 hours (4 days) prior to initial administration
- The patient is confirmed to be infected with the COVID-19, meeting the diagnostic criteria for mild or moderate patients in the latest version of the COVID-19 Pneumonia Diagnosis and Treatment Protocol (Trial 10th Edition) issued by the Chinese Health Commission, and has at least one symptom of SARS-CoV-2, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting and taste disturbance within 96 hours before the first administration of the drug
- According to the 12 common symptom assessment forms of SARS-CoV-2 infection, the total symptom assessment score of the subjects before randomization was ≥ 2 points
- There is at least one possible risk factor for severe/critical SARS-CoV-2: ① Age > 60 years old; (2) Patients with cardiovascular and cerebrovascular diseases (including hypertension), diabetes, chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma), chronic liver and kidney diseases, tumors and other underlying diseases, and the disease should be in a stable period; (3) Immune dysfunction (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs to cause immune dysfunction); ④ Obesity (body mass index ≥30); ⑤ Heavy smokers; ⑥ Those who have not received SARS-CoV-2 vaccine
- Agree to take highly effective contraceptive measures within 3 months after taking the experimental drug
- The subject can communicate well with the researcher, understand and comply with the requirements of the study, and understand and sign the informed consent
Who cannot join
- (1) Severe patients with SARS-CoV-2 meet any of the following criteria
- Shortness of breath, breathing rate ≥ 30 times /min
- At rest, oxygen saturation (SpO2) ≤ 93% during air intake
- Progressive exacerbation of clinical symptoms, lung imaging showed obvious progression of lesions within 24 ~ 48 hours >50%
- Critically ill patients with SARS-CoV-2 meet any of the following criteria
- Respiratory failure occurs and requires mechanical ventilation
Show all 20Show fewer
- Shock occurs
- Combined with other organ failure requires ICU care (3) Allergic constitution, known allergic to the test drug and its components (4) Suspected or confirmed severe, active bacterial, fungal, viral, or other infections (other than COVID-19) that researchers believe may pose a risk when implementing interventions (5) Patients who underwent surgery or chemotherapy or radiotherapy within 28days prior to screening (6) The investigator considers that participation in the study should be prevented from any serious concomitant systemic disease, condition, or disorder (7) Any of the following drugs or treatments were used before screening:
- <!-- -->
- Antiviral therapy (e.g., Paxlovid (nematavir/ritonavir packaged in combination), azvudine tablets, monogravir capsules, ambavirumab/romissuvir injection, or for the duration of the study) is planned to be used within 3 half-life periods before the first dose. COVID-19 human immunoglobulin or convalescent plasma), glucocorticoids, IL-6 inhibitors, non-steroidal anti-inflammatory drugs (nsaids), antineoplastic drugs, anti-transplant rejection drugs, or immunomodulatory biologics
- Those who plan to receive vaccines (including but not limited to COVID-19 vaccine) within 28 days prior to screening or during the study period
- He is on dialysis (8) When screening, any of the laboratory test indicators meet the following standards
- <!-- -->
- ALT or AST >3ULN
- Total bilirubin ≥2 ULN
- White blood cell count > ULN
- Neutrophil absolute value < 0.5×109/L
- Platelet count < 100×109/L
- eGFR <60mL /min/ 1.73m2 (calculated by CKD-EPI formula) (9) Weight ≤40 kg (10) Dizzy needle dizzy blood (11) Participated in other drug clinical trials within 3 months prior to screening (12) Pregnant or lactating women or pregnancy-positive women (13) Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and human immunodeficiency virus (HIV) antibody were positive for any one of the results (14) Patients inappropriate for participation for any other reasons at the investigator's discretion.
- Note:The investigator should ensure that a subject meets all inclusion criteria and does not meet any exclusion criteria at screening.If the conditions of a subject are changed (including laboratory test results)and meet any exclusion criterion at any time from the screening to the first administration,the subject shall beexcluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, add-on Phase III Clinical Study on the Efficacy and Safety of Meplazumab for Injection in Adults With Mild and Moderate COVID-19 Infections
This is a multicenter, randomized, double-blind, placebo-controlled, add-on Phase III clinical study.
Based on the "Diagnosis and Treatment Protocol for COVID-19 Pneumonia (Trial 10th edition)" and according to the results of phase I and Phase II clinical studies, one dose group and one placebo group were used in this experiment. The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment. The clinical study was led by the First Affiliated Hospital of the Chinese People's Liberation Army, and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese People's Liberation Army, the Second Affiliated Hospital of the Chinese People's Liberation Army, the Special Medical Center of the Air Force, and the Third People's Hospital of Shenzhen. A ratio of 1 to 1 was randomly assigned to the experimental or placebo groups.Subjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication. The administration schedule was on day 1 of the trial (intravenous infusion of Meplazumab or placebo once in the morning of D0; The dosage was 0.2 mg/kg. If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved.the first administration of D7, an additional dose of 0.2 mg/kg is given based on the body weight of the subjects.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, add-on Phase III clinical study.
Based on the "Diagnosis and Treatment Protocol for COVID-19 Pneumonia (Trial 10th edition)" and according to the results of phase I and Phase II clinical studies, one dose group and one placebo group were used in this experiment. The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment. The clinical study was led by the First Affiliated Hospital of the Chinese People's Liberation Army, and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese People's Liberation Army, the Second Affiliated Hospital of the Chinese People's Liberation Army, the Special Medical Center of the Air Force, and the Third People's Hospital of Shenzhen. A ratio of 1 to 1 was randomly assigned to the experimental or placebo groups.Subjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication. The administration schedule was on day 1 of the trial (intravenous infusion of Meplazumab or placebo once in the morning of D0; The dosage was 0.2 mg/kg. If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved (remission is defined as: the comprehensive score of the 12 common clinical symptoms of SARS-CoV-2 infection is reduced by at least 1 grade), after the first administration of D7, an additional dose of 0.2 mg/kg is given based on the body weight of the subjects.During hospitalization, each subject completed the relevant examination indicators of each visit according to the test requirements. The subjects can be discharged if they meet one of the following conditions: ① The discharge criteria of Diagnosis and Treatment Protocol for COVID-19 Infection (Trial 10th edition) (the condition is significantly improved, vital signs are stable, body temperature is normal for more than 24 hours, lung imaging lesion is significantly improved) and the nucleic acid test of COVID-19 is negative for 1 time; ② to the 14th day after the first administration; Before discharge, subjects should complete all discharge examinations, and after discharge, subjects do not need to do other examinations, but 12 common clinical symptoms of SARS-CoV-2 infection should be recorded every day until the symptoms return to normal (score: 0), and continue for at least 2 days. Long-term follow-up evaluation was conducted at D15-21 and D22-27 after administration by telephone to determine the safety of the test drug.On day 28 after the first dose (D28±2), subjects returned to the study center again for all group exit examinations. If the subject terminates the trial early for any reason, laboratory testing and chest imaging evaluation are required to complete the efficacy and safety assessment. During the trial, subjects were given.
Both the experimental group and the control group received basic treatment, including symptomatic drugs for 12 common clinical symptoms of SARS-CoV-2 infection. Because NSaids, glucocorticoids and antiviral drugs have great influence on the evaluation of experimental drugs, the following restrictions are made: 1. Subjects are not allowed to self-administer NSaids during the study if their fever is ≥38.5℃ and/or pain related symptoms are assessed as severe among the 12 common clinical symptoms of SARS-CoV-2 infection (score: 3 points), loxoprofen sodium 60 mg/ time, not more than 2 times during the test, and the specific medication information was truthfully recorded; 2. When the subject's symptoms are further aggravated and require loxoprofen sodium for more than 3 times or glucocorticoid drugs, Antiviral therapy (such as Paxlovid (Nematvir tablet/Ritonavir tablet combination package), azivudine tablets, Monoravir capsules, ambavir mab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for convalescent patients), and other antipyretic and analgesic agents other than loxoprofen sodium prescribed in the protocol, The subjects were required to leave the group and complete the last follow-up before leaving the group.
During the study, the researcher can add examination items according to the actual situation, and all abnormal and clinically significant changes occurred in the subjects during the observation period and before leaving the group shall be followed up until the subjects return to normal or are deemed to be clinically insignificant by the researcher.
Study end is defined as the last visit of the last subject or the last data point used for statistical analysis, whichever is the latest. The last subject refers to the last enrolled case.
- Conditions
- COVID-19
- Being tested
- Meplazumab foe 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 foe 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 foe 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.
12 cases of SARS-CoV-2 infection reached the duration of clinical recovery
During the 28-day trial,12 cases of SARS-CoV-2 infection reached the duration of clinical recovery The 12 clinical symptoms of SARS-CoV-2 infection include:nasal congestion or runny nose, dry or sore throat, cough, fever (body temperature), headache, muscle or body pain, shortness of breath (difficulty breathing), weakness or fatigue, shivering or chills, nausea (feeling like vomiting), number of vomiting and number of diarrhea Continuous recovery of clinical symptoms Definition: All 12 common clinical symptoms/signs of SARS-CoV-2 returned to normal and lasted for at least 2 days. Patients with different 12 indicators above were evaluated according to the actual clinical symptoms, and those without clinical symptoms were evaluated with "0 score (none)".
Measured: Day 28
Secondary outcomes (5)
The time and proportion of SARS-CoV-2 nucleic acid to turn negative
The time and proportion of SARS-CoV-2 nucleic acid to turn negative during the 28-day trial
Measured: Day 28
12clinical symptoms of SARS-CoV-2 infection reached the proportion of clinical sustained recovery
During the 28-day trial period,12clinical symptoms of SARS-CoV-2 infection reached the proportion of clinical sustained recovery
Measured: Day 28
The proportion of light/medium to heavy/critical types
The proportion of light/medium to heavy/critical types during the 28-day trial period
Measured: Day 28
Change from baseline in each of the 12 clinical symptom assessments of SARS-Cov-2 infection
Change from baseline in each of the 12 clinical symptom assessments of SARS-Cov-2 infection during the 28-day trial:The score of individual clinical symptoms was performed on a scale scoring of 0 to 3:0 was classified as "none", 1 as "mild", 2 as "moderate", and 3 as "severe"
Measured: Day 28
The time and rate of improvement from baseline in lung imaging during the 28-day tria
Definition of improvement in lung imaging:During the study period,changes in lung imaging from baseline were defined as improvement if they met any of the following criteria:1)Reduction in lesion diameter;2)The number of lesions decreased;3)The number of lung lobes involved in the lesions decreased
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 start30 May 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Based on current epidemic situation in China, there is few Mild and Moderate COVID-19 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT05679492
- Sponsor's protocol ID
- MPZ-III-01
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 15 Sep 2023
- 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, add-on Phase III Clinical Study on the Efficacy and Safety of Meplazumab for Injection in Adults With Mild and Moderate COVID-19 Infections
- ClinicalTrials.gov ID
- NCT05679492
- Acronym / sponsor ID
- MPZ-III-01
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Based on current epidemic situation in China, there is few Mild and Moderate COVID-19 patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jiangsu Pacific Meinuoke Bio Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- 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, randomized, double-blind, placebo-controlled, add-on Phase III clinical study.
Based on the "Diagnosis and Treatment Protocol for COVID-19 Pneumonia (Trial 10th edition)" and according to the results of phase I and Phase II clinical studies, one dose group and one placebo group were used in this experiment. The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment. The clinical study was led by the First Affiliated Hospital of the Chinese People's Liberation Army, and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese People's Liberation Army, the Second Affiliated Hospital of the Chinese People's Liberation Army, the Special Medical Center of the Air Force, and the Third People's Hospital of Shenzhen. A ratio of 1 to 1 was randomly assigned to the experimental or placebo groups.Subjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication. The administration schedule was on day 1 of the trial (intravenous infusion of Meplazumab or placebo once in the morning of D0; The dosage was 0.2 mg/kg. If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved.the first administration of D7, an additional dose of 0.2 mg/kg is given based on the body weight of the subjects.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, add-on Phase III clinical study.
Based on the "Diagnosis and Treatment Protocol for COVID-19 Pneumonia (Trial 10th edition)" and according to the results of phase I and Phase II clinical studies, one dose group and one placebo group were used in this experiment. The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment. The clinical study was led by the First Affiliated Hospital of the Chinese People's Liberation Army, and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese People's Liberation Army, the Second Affiliated Hospital of the Chinese People's Liberation Army, the Special Medical Center of the Air Force, and the Third People's Hospital of Shenzhen. A ratio of 1 to 1 was randomly assigned to the experimental or placebo groups.Subjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication. The administration schedule was on day 1 of the trial (intravenous infusion of Meplazumab or placebo once in the morning of D0; The dosage was 0.2 mg/kg. If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved (remission is defined as: the comprehensive score of the 12 common clinical symptoms of SARS-CoV-2 infection is reduced by at least 1 grade), after the first administration of D7, an additional dose of 0.2 mg/kg is given based on the body weight of the subjects.During hospitalization, each subject completed the relevant examination indicators of each visit according to the test requirements. The subjects can be discharged if they meet one of the following conditions: ① The discharge criteria of Diagnosis and Treatment Protocol for COVID-19 Infection (Trial 10th edition) (the condition is significantly improved, vital signs are stable, body temperature is normal for more than 24 hours, lung imaging lesion is significantly improved) and the nucleic acid test of COVID-19 is negative for 1 time; ② to the 14th day after the first administration; Before discharge, subjects should complete all discharge examinations, and after discharge, subjects do not need to do other examinations, but 12 common clinical symptoms of SARS-CoV-2 infection should be recorded every day until the symptoms return to normal (score: 0), and continue for at least 2 days. Long-term follow-up evaluation was conducted at D15-21 and D22-27 after administration by telephone to determine the safety of the test drug.On day 28 after the first dose (D28±2), subjects returned to the study center again for all group exit examinations. If the subject terminates the trial early for any reason, laboratory testing and chest imaging evaluation are required to complete the efficacy and safety assessment. During the trial, subjects were given.
Both the experimental group and the control group received basic treatment, including symptomatic drugs for 12 common clinical symptoms of SARS-CoV-2 infection. Because NSaids, glucocorticoids and antiviral drugs have great influence on the evaluation of experimental drugs, the following restrictions are made: 1. Subjects are not allowed to self-administer NSaids during the study if their fever is ≥38.5℃ and/or pain related symptoms are assessed as severe among the 12 common clinical symptoms of SARS-CoV-2 infection (score: 3 points), loxoprofen sodium 60 mg/ time, not more than 2 times during the test, and the specific medication information was truthfully recorded; 2. When the subject's symptoms are further aggravated and require loxoprofen sodium for more than 3 times or glucocorticoid drugs, Antiviral therapy (such as Paxlovid (Nematvir tablet/Ritonavir tablet combination package), azivudine tablets, Monoravir capsules, ambavir mab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for convalescent patients), and other antipyretic and analgesic agents other than loxoprofen sodium prescribed in the protocol, The subjects were required to leave the group and complete the last follow-up before leaving the group.
During the study, the researcher can add examination items according to the actual situation, and all abnormal and clinically significant changes occurred in the subjects during the observation period and before leaving the group shall be followed up until the subjects return to normal or are deemed to be clinically insignificant by the researcher.
Study end is defined as the last visit of the last subject or the last data point used for statistical analysis, whichever is the latest. The last subject refers to the last enrolled case.
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 foe 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 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age range from 18 to 80 (including 18 and 80 years old), male or female
- The subject tested positive for SARS-CoV-2 by nucleic acid test within 96 hours (4 days) prior to initial administration
- The patient is confirmed to be infected with the COVID-19, meeting the diagnostic criteria for mild or moderate patients in the latest version of the COVID-19 Pneumonia Diagnosis and Treatment Protocol (Trial 10th Edition) issued by the Chinese Health Commission, and has at least one symptom of SARS-CoV-2, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting and taste disturbance within 96 hours before the first administration of the drug
- According to the 12 common symptom assessment forms of SARS-CoV-2 infection, the total symptom assessment score of the subjects before randomization was ≥ 2 points
- There is at least one possible risk factor for severe/critical SARS-CoV-2: ① Age > 60 years old; (2) Patients with cardiovascular and cerebrovascular diseases (including hypertension), diabetes, chronic pulmonary diseases (chronic obstructive pulmonary disease, moderate to severe asthma), chronic liver and kidney diseases, tumors and other underlying diseases, and the disease should be in a stable period; (3) Immune dysfunction (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs to cause immune dysfunction); ④ Obesity (body mass index ≥30); ⑤ Heavy smokers; ⑥ Those who have not received SARS-CoV-2 vaccine
Key exclusion criteria (20 listed)
- (1) Severe patients with SARS-CoV-2 meet any of the following criteria
- <!-- -->
- <!-- -->
- Note:The investigator should ensure that a subject meets all inclusion criteria and does not meet any exclusion criteria at screening.If the conditions of a subject are changed (including laboratory test results)and meet any exclusion criterion at any time from the screening to the first administration,the subject shall beexcluded from the study.
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 foe 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
12 cases of SARS-CoV-2 infection reached the duration of clinical recovery
Time frame: Day 28
During the 28-day trial,12 cases of SARS-CoV-2 infection reached the duration of clinical recovery The 12 clinical symptoms of SARS-CoV-2 infection include:nasal congestion or runny nose, dry or sore throat, cough, fever (body temperature), headache, muscle or body pain, shortness of breath (difficulty breathing), weakness or fatigue, shivering or chills, nausea (feeling like vomiting), number of vomiting and number of diarrhea Continuous recovery of clinical symptoms Definition: All 12 common clinical symptoms/signs of SARS-CoV-2 returned to normal and lasted for at least 2 days. Patients with different 12 indicators above were evaluated according to the actual clinical symptoms, and those without clinical symptoms were evaluated with "0 score (none)".
5 secondary outcomes
The time and proportion of SARS-CoV-2 nucleic acid to turn negative
Time frame: Day 28
12clinical symptoms of SARS-CoV-2 infection reached the proportion of clinical sustained recovery
Time frame: Day 28
The proportion of light/medium to heavy/critical types
Time frame: Day 28
Change from baseline in each of the 12 clinical symptom assessments of SARS-Cov-2 infection
Time frame: Day 28
The time and rate of improvement from baseline in lung imaging during the 28-day tria
Time frame: Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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 foe 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 7 inclusion and 20 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: withdrawn, 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 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 was withdrawn before enrolling participants, so there are no results.
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?
12 cases of SARS-CoV-2 infection reached the duration of clinical recovery (time frame: Day 28). 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 15 Sep 2023.