Publications by authors named "Manuel Baca Cots"
Article Synopsis
- The Phase 3 MELODY trial evaluated the effectiveness of nirsevimab in preventing RSV in children during their second RSV season.
- Results showed that there was no increase in medically attended RSV lower respiratory infections or disease severity in children who received nirsevimab compared to those who received a placebo.
- The clinical trial is registered at Clinicaltrials.gov under NCT03979313, confirming its scientific validity.
Efficacy of nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: a pooled analysis of randomised controlled trials.
Eric A F Simões Shabir A Madhi William J Muller Victoria Atanasova Miroslava Bosheva Manuel Baca Cots
Lancet Child Adolesc Health
March 2023
Article Synopsis
- Nirsevimab is a monoclonal antibody shown to protect healthy infants from RSV-related lower respiratory tract infections in two clinical trials (phase 2b and MELODY), demonstrating safety similar to the existing drug palivizumab!* -
- Infants were dosed based on weight (50 mg for those <5 kg and 100 mg for ≥5 kg) and both the pooled efficacy and safety of nirsevimab were analyzed, particularly in infants at higher risk for severe RSV infections due to health conditions or preterm birth.* -
- The primary goal was to determine the incidence of RSV LRTI requiring medical attention within 150 days post-injection, with secondary focuses on hospital admissions and very
Article Synopsis
- Respiratory syncytial virus (RSV) significantly affects infants, leading to serious lower respiratory infections, and nirsevimab is a monoclonal antibody designed to combat this infection.
- In a study involving 1490 infants, those receiving nirsevimab showed a 74.5% effectiveness in preventing medically attended RSV-associated infections compared to the placebo group.
- The results indicate that while nirsevimab reduced the incidence of RSV-related complications, the overall rate of serious adverse events was similar between the nirsevimab and placebo groups, suggesting a reasonable safety profile for the treatment.