Protocol Phase III Clinical Trial on the Efficacy and Safety of Meplazumab ... in the Treatment of Post-covid-19, 2023

The actual study start date was March 2023, the estimated primary end date was 1 June 2023 and the estimated study completion date is 1 October 2023.

Clinical Trials link: https://clinicaltrials.gov/ct2/show/NCT05813587?term=Meplazumab&draw=2&rank=8

Randomized, double-blind, placebo-controlled, loading phase III clinical study.

"This test is in the new type of coronavirus infection therapy and 10 (trial version) "and" new coronavirus pneumonia antiviral drug clinical trial technical guidelines (try out) ", on the basis of according to the results of the phase I and phase II clinical study to set up an experimental group and a placebo group, experimental group on the basis of medicines for load test, The control group was loaded with placebo as the base treatment.

A planned cohort of 144 patients with Post-COVID-19 (120 +20% dropped out) was randomly assigned in a 1:1 ratio to the experimental group or the placebo group. Mepozumab or placebo was intravenously infused at a dose of 0.2 mg/kg on day 1 (D0). If the clinical symptoms of Post-COVID-19 were not relieved (remission was defined as a decrease in the Post-COVID-19 composite score for at least 2 days), an additional dose of 0.2 mg/kg was administered on day 7 after the first dose, and the actual dose was calculated according to the body weight of the subject. The participants were asked to record the clinical symptoms of Post-COVID-19 daily during the trial. The absent clinical symptoms were evaluated as "zero (none)", and the present clinical symptoms were recorded until they returned to normal (score: zero), which lasted for at least 2 days.

On the 28th day (D28±3) after the first dose, the subjects were required to return to the study center again, return their diary cards, and complete each exit examination. If a participant stops the trial early for various reasons, laboratory testing is required to complete the efficacy and safety assessment. During the trial, the subjects were treated according to the type and severity of adverse events according to the clinical diagnosis and treatment standards."

Sponsor:Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
First Affiliated Hospital of the Air Force Medical University
Xi'an, China

"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."

 

So, a sizeable Stage 3 study in China of an anti-viral expected to target SARS-CoV-2, as a treatment for Post-Covid-19. The underlying hypothesis presumably is that a persisting SARS-CoV-2 infection is causing the symptoms.

Inclusion criteria:

1. Age 18 to 84 (including 18 and 84), male and female
2. 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
3. According to the Post-COVID-19 Clinical symptom assessment form , the total symptom assessment score of the subjects was ≥2 before randomization
4. Agree to use highly effective birth control within 3 months of using the experimental drug
5. 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

 

It looks as though Meplazumab has been found to be useful in the treatment of severe Covid-19, substantially reducing mortality - 2023 Chinese study:

Some of the authors of that Covid-19 study are also employees of the sponsor of this post-Covid study (Jiangsu Pacific Meinuoke Biopharmaceutical).

 

Article about the drug and its use for Covid-19.