To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19

NCT05813587 | Completed Phase 3

• 1 other identifier: MPZ-III-02
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was a randomized, double-blind, placebo-controlled, loading phase III clinical study.

Conditions

Post-COVID-19

Outcome Measures

Primary Outcomes (1)

• 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)"

  Day28

Study Arms (2)

Meplazumab

EXPERIMENTAL

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

Biological: Meplazumab for injection

Placebo

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

Meplazumab for 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 - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Patients with allergic constitution and known allergic to the test drug and its components
• \. Patients who underwent surgery or chemotherapy or radiotherapy within 28 days before screening
• \. Patients had a serious systemic disease, condition, or disorder, etc., that was deemed by the investigator to be inappropriate for participation in the study
• \. 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
• \. At the time of screening, any of the laboratory test indicators meet the following criteria
• ALT or AST \>3ULN
• 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
• \. Weight ≤40 kg
• \. Dizzy with needles and blood
• \. Had participated in other drug clinical trials within 3 months before screening

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

Interventions

meplazumab; Injections; Saline Solution

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; 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: April 10, 2023
• First Posted: April 14, 2023
• Study Start: March 23, 2023
• Primary Completion: September 14, 2023
• Study Completion: October 26, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-02

Locations

CN (1)