ABSTRACT
Background. More data are needed to understand the risk for COVID-19 severity among pediatric asthma patients. We present findings from a national registry characterizing COVID-19 hospitalizations among pediatric asthma patients. Methods. Data were obtained from the Pediatric COVID-19 US Registry, which included medical records of COVID-19 cases < 21 years old between March 2020 and May 2021. Those with asthma were eligible while immunocompromised and transplant cases were excluded. Descriptive statistics and chi-square tests were performed. Results. Of the 1089 eligible asthma cases, half were 12 to 17 years old [Figure 1], the majority were male [Figure 2], a third Black African American [Figure 3], and most were Non-Hispanic/Latino 825 (76%). 242 (22%) reported a history of smoking. A fourth of cases (257 (23.6%) were hospitalized for COVID-19. More than half (54%) reported asthma as their only pre-existing condition. The majority (n=71, 28%) were taking regular inhaled corticosteroids. Almost half (n=120, 47%) had abnormal chest radiographic findings, 20 (7.8%) had abnormal CT findings, and 24 (9%) progressed to lower respiratory infection. About 10% (n=25) needed mechanical ventilation. A third (n=88, 34%) required ICU care with 33% of those receiving inhaled corticosteroids. A quarter needed mechanical ventilation [Figure 5]. Compared to asthma patients not hospitalized for COVID-19, those hospitalized were significantly (P< 0.05) more likely to be non-Hispanic, have multiple pre-existing conditions, and be obese [Figure 6]. Compared to those not admitted to ICU, ICU cases were significantly more likely to be obese and be diagnosed with MIS-C [Figure 7]. Demographics Conclusion. This is one of the first national studies examining COVID-19 among pediatric cases with asthma. Our data suggest that children with asthma who have multiple pre-existing conditions and/or are obese have a higher risk for hospitalization. These early data may aid clinicians in developing future prospective studies to understand COVID-19 risk among this vulnerable population. (Figure Presented).
ABSTRACT
Background. Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in infants. Nirsevimab is a single-dose monoclonal antibody with extended half-life that was shown to protect preterm infants 29 to < 35 weeks gestation against RSV LRTI. However, most medically attended (MA) cases occur in otherwise healthy, term infants for whom there is currently no effective RSV prevention strategy. We report the primary analysis of efficacy and safety, along with the impact of nirsevimab in late preterm and term infants (≥ 35 weeks gestation) in the phase 3 MELODY study (NCT03979313). Methods. Infants were randomized 2:1 to receive one intramuscular injection of nirsevimab (50 mg if < 5 kg;100 mg if ≥ 5 kg at dosing) or placebo entering their first RSV season. The primary endpoint was the incidence of MA RSV LRTI over 150 days postdose. Cases met predefined clinical criteria of disease severity and were confirmed by real-time reverse-transcriptase PCR. Safety was evaluated through 360 days postdose. Enrollment started on 23 July 2019 and was suspended following the declaration of the COVID-19 pandemic by the WHO on 11 March 2020. Results. Overall, 1490 infants were randomized and included in the intent-totreat population;1465 (98%) completed the 150-day efficacy follow-up, and 1367 (92%) completed the 360-day safety follow-up. The incidence of MA RSV LRTI was 1.2% (n=12/994) in the nirsevimab group and 5.0% (n=25/496) in the placebo group, giving nirsevimab an efficacy of 74.5% (95% confidence interval [CI]: 49.6, 87.1;p< 0.0001). Nirsevimab averted 93.6 (95% CI 63.0, 124.0) MA LRTIs per 1000 infants dosed. Nirsevimab was well tolerated, with similar rates of adverse events (87.4% nirsevimab;86.8% placebo) and serious adverse events (6.8% nirsevimab;7.3% placebo) between groups. Conclusion. In this phase 3 study, a single dose of nirsevimab protected late preterm and term infants against MA RSV LRTI over an RSV season with a favorable safety profile. Approximately 11 infants need to be immunized to prevent 1 case of LRTI;nirsevimab has the potential to be an important intervention to reduce the burden of RSV LRTI in healthy infants.