Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19

NCT05679492 | Withdrawn Phase 3

• 1 other identifier: MPZ-III-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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)".

  Day 28

Secondary Outcomes (5)

• The time and proportion of SARS-CoV-2 nucleic acid to turn negative

  Day 28

• 12clinical symptoms of SARS-CoV-2 infection reached the proportion of clinical sustained recovery

  Day 28

• The proportion of light/medium to heavy/critical types

  Day 28

• Change from baseline in each of the 12 clinical symptom assessments of SARS-Cov-2 infection

  Day 28

• The time and rate of improvement from baseline in lung imaging during the 28-day tria

  Day 28

Study Arms (2)

Meplazumab

EXPERIMENTAL

First dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8

Biological: Meplazumab foe injection

Placebo

PLACEBO COMPARATOR

First dose: control - Day 1; second dose: control - Day 8

Other: Normal saline

Interventions

Meplazumab foe injection BIOLOGICAL

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.

Meplazumab

Normal saline OTHER

Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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%
• (2) Critically ill patients with SARS-CoV-2 meet any of the following criteria
• Respiratory failure occurs and requires mechanical ventilation
• 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

Sponsors & Collaborators

• Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd: lead

Study Sites (1)

First Affiliated Hospital of the Air Force Medical University

Xi'an, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 11, 2023
• Study Start: May 30, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-01

Locations

CN (1)