Meplazumab treats COVID-19 pneumonia: an open-labelled, concurrent controlled add-on clinical trial

  1. Huijie Bian
  2. Zhao-Hui Zheng
  3. Ding Wei
  4. Zheng Zhang
  5. Wen-Zhen Kang
  6. Chun-Qiu Hao
  7. Ke Dong
  8. Wen Kang
  9. Jie-Lai Xia
  10. Jin-Lin Miao
  11. Rong-Hua Xie
  12. Bin Wang
  13. Xiu-Xuan Sun
  14. Xiang-Min Yang
  15. Peng Lin
  16. Jie-Jie Geng
  17. Ke Wang
  18. Hong-Yong Cui
  19. Kui Zhang
  20. Xiao-Chun Chen
  21. Hao Tang
  22. Hong Du
  23. Na Yao
  24. Shuang-Shuang Liu
  25. Lin-Na Liu
  26. Zhe Zhang
  27. Zhao-Wei Gao
  28. Gang Nan
  29. Qing-Yi Wang
  30. Jian-Qi Lian
  31. Zhi-Nan Chen
  32. Ping Zhu
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Abstract

Background

SARS-CoV-2 is a novel human coronavirus, there is no specific antiviral drugs. It has been proved that host-cell-expressed CD147 could bind spike protein of SARS-CoV-2 and involve in host cell invasion. Antibody against CD147 could block the infection of SARS-CoV-2. We aimed to assess the efficacy and safety of meplazumab, a humanized anti-CD147 antibody, as add-on therapy in patients with COVID-19 pneumonia.

Methods

All patients received recommended strategy from Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatments released by National Health Commission of China. Eligible patients were add-on administered 10 mg meplazumab intravenously at days 1, 2, and 5. Patients hospitalized in the same period were observed as concurrent control. The endpoints include virological clearance rate, case severity, chest radiographic, and laboratory test. This trial was approved by the Ethics Committee of Institution at the Tangdu hospital, and registered with ClinicalTrials.gov, NCT 04275245.

Findings

17 patients were enrolled and assigned to meplazumab group between Feb 3, 2020 and Feb 10, 2020. 11 hospitalized patients served as concurrent control. Baseline characteristics were generally balanced across two groups. Compared to control group, meplazumab treatment significantly improved the discharged (p=0.005) and case severity (p=0.021) in patients. The time to virus negative in meplazumab group was reduced than that in control group (median 3, 95%CI[1.5-4.5] vs. 13, [6.5-19.5]; p=0.045, HR=0.374, 95%CI[0.143-0.978]). The percentages of patients recovered to the normal lymphocyte count and CRP concentration were also increased remarkably and rapidly in meplazumab group. No adverse effect was found in meplazumab-treated patients.

Interpretation

Meplazumab efficiently improved the recovery of patients with SARS-CoV-2 pneumonia with a favorable safety profile. Our results support to carry out a large-scale investigation of meplazumab as a treatment for COVID-19 pneumonia.

Funding

National Science and Technology Major Project.

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