History
The safety and efficacy of clesrovimab were supported by two clinical trials (trials 004 and 007). [3] The key measure of efficacy was the incidence of RSV-associated medically-attended lower respiratory infection characterized as cough or difficulty breathing and requiring ≥1 indicator of lower respiratory infection (wheezing, rales/crackles) or severity (chest wall in-drawing/retractions, hypoxemia, tachypnea, dehydration due to respiratory symptoms) through 150 days after dosing. [3] Medically attended includes all healthcare provider visits in settings such as outpatient clinic, clinical study site, emergency department, urgent care center, and/or hospital. [3]
Trials 004 and 007 were randomized, multicenter clinical trials to evaluate the safety, pharmacokinetics and efficacy of clesrovimab in preventing RSV-associated medically-attended lower respiratory infection. [3] Trial 004 was a double-blind, placebo-controlled trial in which 3,614 infants (born at ≥29 to <35 weeks GA or at ≥35 weeks GA) were randomized and received at least one dose of either clesrovimab or placebo. [3] Trial 007 was a partially-blind, palivizumab-controlled trial in which 896 infants who were at increased risk for severe RSV disease (born at ≥29 to ≤35 weeks GA or with chronic lung disease of prematurity or congenital heart disease of any GA) were randomized and received at least one dose of clesrovimab or palivizumab. [3] Trial 004 was a randomized, double-blind placebo-controlled, multi-site trial conducted in 22 countries from the Northern and Southern Hemispheres to evaluate the efficacy of clesrovimab in early and moderate preterm infants (≥29 to <35 weeks gestational age) and late preterm and full-term infants (≥35 weeks gestational age). [3] Among 3,614 participants who received clesrovimab or saline placebo, the median age of infants was 3.1 months (range: 0 to 12 months); 80% were younger than 6 months, 16% were between 6 to 9 months, and 4% were 9 months of age and older; and 51% were male. [3] Of these participants, 18% were gestational age between 29 weeks and 35 weeks, and 82% were gestational age 35 weeks and older. [3] Trial 007 was a randomized, partially-blind, palivizumab-controlled, multi-site trial conducted in 27 countries from the Northern and Southern Hemispheres to evaluate the efficacy of clesrovimab in early (<29 weeks gestational age) or moderate preterm infants (≥29 to ≤35 weeks gestational age), and infants with chronic lung disease of prematurity or congenital heart disease of any gestational age, who are at increased risk for severe RSV disease. [3] Among 896 participants who received clesrovimab or palivizumab, the median age of infants was 2.5 months (range: 0 to 12 months); 89% were younger than 6 months, 9% were between 6 to 9 months, and 2% were 9 months of age and older; and 50% were male. [3] Of these participants, 28% had chronic lung disease, 11% had congenital heart disease, 6% were gestational age younger than 29 weeks with neither chronic lung disease nor congenital heart disease and 55% were gestational age 29 weeks and older with neither chronic lung disease nor congenital heart disease. [3]
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