Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19
brief summary
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.
detailed description
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.
official title
A Multicenter, Randomized, Double-blind, Placebo-controlled, add-on Phase III Clinical Study on the Efficacy and Safety of Meplazumab for Injection in Adults With Mild and Moderate COVID-19 Infections