Meplazumab treats COVID-19 pneumonia: an open-labelled, concurrent controlled add-on clinical trial
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
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.
Article activity feed
-
-
-
SciScore for 10.1101/2020.03.21.20040691: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The study protocol and consent were approved by the Independent Ethics Committee of Institution for National Drug Clinical Trials at the Tangdu hospital (K202002-01). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The inclusion criteria are as follows: men and women aged 18 to 78 years; patients with common, severe, or critical COVID-19 pneumonia were laboratory and clinical diagnosed according to Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatments released by National Health Commission of China;18 the subjects must understand the study and be willing to participate in the … SciScore for 10.1101/2020.03.21.20040691: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The study protocol and consent were approved by the Independent Ethics Committee of Institution for National Drug Clinical Trials at the Tangdu hospital (K202002-01). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The inclusion criteria are as follows: men and women aged 18 to 78 years; patients with common, severe, or critical COVID-19 pneumonia were laboratory and clinical diagnosed according to Chinese Clinical Guidance for COVID-19 Pneumonia Diagnosis and Treatments released by National Health Commission of China;18 the subjects must understand the study and be willing to participate in the study. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analyses were performed using the SPSS software, version 23.0 and GraphPad Prism software, version 5.0. SPSSsuggested: (SPSS, RRID:SCR_002865)GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04275245 Recruiting Clinical Study of Anti-CD147 Humanized Meplazumab for Inject… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
-