Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19

Overview

This is a multicenter, randomized, double-blind, placebo-controlled, add-on Phase III clinical study. Based on the "Diagnosis and Treatment Protocol for COVID-19 Pneumonia (Trial 10th edition)" and according to the results of phase I and Phase II clinical studies, one dose group and one placebo group were used in this experiment. The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment. The clinical study was led by the First Affiliated Hospital of the Chinese People's Liberation Army, and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese People's Liberation Army, the Second Affiliated Hospital of the Chinese People's Liberation Army, the Special Medical Center of the Air Force, and the Third People's Hospital of Shenzhen. A ratio of 1 to 1 was randomly assigned to the experimental or placebo groups.Subjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication. The administration schedule was on day 1 of the trial (intravenous infusion of Meplazumab or placebo once in the morning of D0; The dosage was 0.2 mg/kg. If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved.the first administration of D7, an additional dose of 0.2 mg/kg is given based on the body weight of the subjects.

This is a multicenter, randomized, double-blind, placebo-controlled, add-on Phase III clinical study. Based on the "Diagnosis and Treatment Protocol for COVID-19 Pneumonia (Trial 10th edition)" and according to the results of phase I and Phase II clinical studies, one dose group and one placebo group were used in this experiment. The experimental group was add-on experimental drugs for basic treatment and the control group was add-on placebo for basic treatment. The clinical study was led by the First Affiliated Hospital of the Chinese People's Liberation Army, and 1320 adult subjects with mild and medium COVID-19 infection were enrolled in the First Affiliated Hospital of the Chinese People's Liberation Army, the Second Affiliated Hospital of the Chinese People's Liberation Army, the Special Medical Center of the Air Force, and the Third People's Hospital of Shenzhen. A ratio of 1 to 1 was randomly assigned to the experimental or placebo groups.Subjects should have tested positive for COVID-19 nucleic acid in a laboratory and developed at least one symptom of SARS-CoV-2 within 96 hours prior to medication. The administration schedule was on day 1 of the trial (intravenous infusion of Meplazumab or placebo once in the morning of D0; The dosage was 0.2 mg/kg. If the 12 common clinical symptoms of SARS-CoV-2 infection are not relieved (remission is defined as: the comprehensive score of the 12 common clinical symptoms of SARS-CoV-2 infection is reduced by at least 1 grade), after the first administration of D7, an additional dose of 0.2 mg/kg is given based on the body weight of the subjects.During hospitalization, each subject completed the relevant examination indicators of each visit according to the test requirements. The subjects can be discharged if they meet one of the following conditions: ① The discharge criteria of Diagnosis and Treatment Protocol for COVID-19 Infection (Trial 10th edition) (the condition is significantly improved, vital signs are stable, body temperature is normal for more than 24 hours, lung imaging lesion is significantly improved) and the nucleic acid test of COVID-19 is negative for 1 time; ② to the 14th day after the first administration; Before discharge, subjects should complete all discharge examinations, and after discharge, subjects do not need to do other examinations, but 12 common clinical symptoms of SARS-CoV-2 infection should be recorded every day until the symptoms return to normal (score: 0), and continue for at least 2 days. Long-term follow-up evaluation was conducted at D15-21 and D22-27 after administration by telephone to determine the safety of the test drug.On day 28 after the first dose (D28±2), subjects returned to the study center again for all group exit examinations. If the subject terminates the trial early for any reason, laboratory testing and chest imaging evaluation are required to complete the efficacy and safety assessment. During the trial, subjects were given. Both the experimental group and the control group received basic treatment, including symptomatic drugs for 12 common clinical symptoms of SARS-CoV-2 infection. Because NSaids, glucocorticoids and antiviral drugs have great influence on the evaluation of experimental drugs, the following restrictions are made: 1. Subjects are not allowed to self-administer NSaids during the study if their fever is ≥38.5℃ and/or pain related symptoms are assessed as severe among the 12 common clinical symptoms of SARS-CoV-2 infection (score: 3 points), loxoprofen sodium 60 mg/ time, not more than 2 times during the test, and the specific medication information was truthfully recorded; 2. When the subject's symptoms are further aggravated and require loxoprofen sodium for more than 3 times or glucocorticoid drugs, Antiviral therapy (such as Paxlovid (Nematvir tablet/Ritonavir tablet combination package), azivudine tablets, Monoravir capsules, ambavir mab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for convalescent patients), and other antipyretic and analgesic agents other than loxoprofen sodium prescribed in the protocol, The subjects were required to leave the group and complete the last follow-up before leaving the group. During the study, the researcher can add examination items according to the actual situation, and all abnormal and clinically significant changes occurred in the subjects during the observation period and before leaving the group shall be followed up until the subjects return to normal or are deemed to be clinically insignificant by the researcher. Study end is defined as the last visit of the last subject or the last data point used for statistical analysis, whichever is the latest. The last subject refers to the last enrolled case.