Study to Assess the Effect of Meplazumab on COVID-19

NCT04586153 | Completed Phase 2 FDA Drug

• 1 other identifier: MPZ-II-02
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

This phase2/3 study will be conducted to evaluate the safety and efficacy of Meplazumab in addition to Standard of Care for the treatment of Corona Virus Disease(COVID) 19 in hospitalized adults

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Mortality (based on the interim analysis of Stage 1 data)

  Mortality (based on the interim analysis of Stage 1 data)

  During the evaluation period (Day 1 to Day 29)

• Proportion of subjects alive and discharged without supplemental oxygen

  To evaluate live discharge

  During the evaluation period (Day 1 to Day 29)

Secondary Outcomes (3)

• Changes from baseline in cytokine, chemokines and related inflammatory factors.

  During the evaluation period (Day 1 to Day 29)

• Viral load

  During the evaluation period (Day 1 to Day 29)

• Viral negative rate of SARS-Cov-2 nucleic acid

  During the evaluation period (Day 1 to Day 29)

Study Arms (2)

Meplzaumb

EXPERIMENTAL

This arm is combined with 3 groups, low dose, middle dose, and high dose. Low dose group: First dose: 0.12 mg/kg - Day 1; second dose: control - Day 8 Middle dose group: First dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8 High dose group: First dose: 0.3 mg/kg - Day 1; second dose: 0.3 mg/kg - Day 8

Drug: Meplazumab for Injection

Placebo

PLACEBO COMPARATOR

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

Drug: Sterile normal saline (0.9%)

Interventions

Meplazumab for Injection DRUG

humanized antibody target CD147

Meplzaumb

Sterile normal saline (0.9%) DRUG

Sterile normal saline (0.9%)

Placebo

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years) with laboratory-confirmed SARS CoV 2 infection as determined by PCR or other commercial or public health assay, which is FDA cleared or approved for emergency use (test results must be obtained within 72 hours of Day
• A score of Grade 3 (hospitalized, requiring supplemental oxygen) or Grade 4 (hospitalized, on non-invasive ventilation or high flow oxygen devices) on the 6-point ordinal scale.
• Willingness and ability to comply with study-related procedures and assessments.
• Ability to provide informed consent signed by study subject or legally authorized representative.
• Male and/or female
• a)Male subjects:
• A male subject must agree to use contraception as detailed in Appendix 12.3 of this protocol during the treatment period and for at least 6 months, corresponding to time needed to eliminate study treatment for both genotoxic and teratogenic study treatments, after the last dose of study treatment.
• b)Female subjects:
• A female subject is eligible to participate if she is not pregnant (see Appendix 12.3), not planning to get pregnant in the next 6 months, not breastfeeding, and at least 1 of the following conditions applies:
• i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 12.3. OR ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 12.3 during the treatment period and for at least 130 days, (5 terminal half lives and, for genotoxic products, an additional 30 days, corresponding to time needed to eliminate study treatment plus 30 days for study treatments with genotoxic potential) after the last dose of study treatment.

You may not qualify if:

• Any physical examination findings, laboratory abnormality, and/or history of any illness, that in the study Investigator's judgment, could jeopardize the safety of the subject by their participation in the study.
• Subjects with evidence of critical COVID 19 illness, defined by at least 1 of the following: respiratory failure; shock (defined by systolic blood pressure \<90 mm Hg, or diastolic blood pressure \<60 mm Hg, or requiring vasopressors); or multi-organ dysfunction/failure.
• Subjects requiring extracorporeal membrane oxygenation (ECMO).
• Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate(eGFR) mL/min/1.73 m2 \< 30).
• Pregnant or breast feeding.
• Anticipated transfer to another hospital which is not a study site within 72 hours.
• Allergy to any study medication.
• Use of anticancer, antitransplant rejection, or immunomodulatory biological drug or kinase inhibitor (eg, tocilizumab, sarilumab) or Janus kinase inhibitors (within 30 days of enrollment or 5 times the half-life \[whichever is longer\]).
• Chronic glucocorticosteroid use equivalent to daily oral prednisone \>10 mg per day (10 mg oral prednisone every other day is allowed).
• Live (live-attenuated) vaccines are not permitted within 2 weeks prior to randomization or during the study treatment and safety follow-up periods.
• 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.
• Total bilirubin (TBL) \>2 × upper limit of normal (ULN), or alanine aminotransferase (ALT) \>5 × ULN, or aspartate aminotransferase (AST) \>5 × ULN, or alkaline phosphatase \>5 × ULN.
• Platelet \<50×109/L, or hemoglobin \<60g/L.
• Glomerular filtration rate \<30 milliliter(mL)/min/1.73 m2, or serum creatinine increased by 0.5 mg/dL within 7 days, or oliguria (\<400 mL/24 hour), or anuria (\<100 mL/24 hour).
• Any physical examination findings, laboratory abnormality, and/or history of any illness, that in the study Investigator's judgment, could jeopardize the safety of the subject by their participation in the study.

Sponsors & Collaborators

• Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd: lead

Study Sites (1)

Pesquisare Saúde

Santo André, São Paulo, Brazil

Location

Related Publications (2)

• Bian H, Chen L, Zheng ZH, Sun XX, Geng JJ, Chen R, Wang K, Yang X, Chen SR, Chen SY, Xie RH, Zhang K, Miao JL, Jia JF, Tang H, Liu SS, Shi HW, Yang Y, Chen XC, Malhotra V, Nasir N, Khanum I, Mahmood F, Hamid S, Stadnik CMB, Itinose K, de Oliveira CCC, Dusilek C, Rivabem L, Cavalcante AJW, Lopes SS, Saporito WF, Fucci FJC, Simon-Campos JA, Wang L, Liu LN, Wang QY, Wei D, Zhang Z, Chen ZN, Zhu P. Meplazumab in hospitalized adults with severe COVID-19 (DEFLECT): a multicenter, seamless phase 2/3, randomized, third-party double-blind clinical trial. Signal Transduct Target Ther. 2023 Jan 30;8(1):46. doi: 10.1038/s41392-023-01323-9.

  PMID: 36717539 DERIVED

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

meplazumab; Injections

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)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 14, 2020
• Study Start: February 15, 2021
• Primary Completion: December 2, 2022
• Study Completion: December 18, 2022
• Last Updated: September 15, 2023

Record last verified: 2022-05

Locations

BR (1)