Post-COVID-19 Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Loaded Phase III Clinical Trial on the Efficacy and Safety of Mepozumab for Injection in the Treatment of Post-COVID-19
This trial was a 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. ;