In a recent study posted to the medRxiv* preprint server, researchers discussed patient features, treatment-associated process measures, and outcomes associated with early monoclonal antibody and antiviral therapy in high-risk pediatric patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant.
The SARS-CoV-2 Omicron surge has resulted in significantly increased hospitalization rates in children of zero to four years of age. Subsequently, Omicron variant predominance has led to the emergence of new coronavirus disease 2019 (COVID-19) therapy regimens in high-risk children and adolescents.
The United States (US) Food and Drug Administration (FDA) has granted emergency use authorization (EUA) of monoclonal antibody sotrovimab and oral antiviral drugs nirmatrelvir/ritonavir for SARS-CoV-2-positive children over 12 years and remdesivir for children less than 12 years.
However, the studies submitted for EUA approval included very limited data for the safety and efficacy of these drugs in pediatric patients. Therefore, information regarding early monoclonal antibody and antiviral therapy in the high-risk pediatric population is essentially required amid the COVID-19 pandemic.
To fill this gap, this study was designed to prioritize the use of monoclonal antibody sotrovimab and antiviral therapy nirmatrelvir/ritonavir or remdesivir for immunocompromised and unvaccinated pediatric and adolescent patients with additional risk factors such as obesity, respiratory technology dependence, etc.
In the present study, the subjects were pediatric and adolescent patients admitted to Seattle Children’s Hospital for whom treatment with COVID-19 therapy was requested between December 22nd, 2021, to January 30th, 2022.
To determine COVID-19 treatment modality, parameters like patient’s location, age, oral treatment tolerance, possible drug interaction, underlying hepatic and renal function and patient bed availability or current infusion center were considered.
Medical records of patients were reviewed to assess demographic characteristics, underlying pathological conditions, COVID-19 vaccination status, number of days since first symptom or positive polymerase chain reaction (PCR) test, medications adherence, treatment-related adverse events, hospitalizations, and emergency department (ED) visits within seven days of receipt of treatment request.
The findings of the study demonstrated that 70% of COVID-19-positive high-risk pediatric patients received approval for nirmatrelvir/ritonavir or remdesivir, and sotrovimab for SARS-CoV-2 treatment. Over 66% of the request were received from immunocompromised patients with malignancy.
The authors observed that vaccination status and refusal for consideration in high-risk categories were the most common reasons for therapy denial. In patients for whom therapy was requested versus patients for whom therapy has been approved, no difference was noted in race and ethnicity categorizations.
SARS-CoV-2 therapy was not administered to 19 patients despite approval due to family refusal and improved symptoms. Remdesivir was administered majorly in inpatient settings, while sotrovimab treatment in the outpatient infusion center.
Adverse events occurrence were rare following the administration of COVID-19 therapies in pediatric patients. Moreover, after remdesivir treatment, no patient showed an increase in creatinine or alanine aminotransferase.
Overall, three new hospitalizations occurred in patients for COVID-19-related disease in the follow-up period. It included one patient for whom treatment approval was denied, one who got approval but did not receive sotrovimab treatment, and one after treatment with remdesivir.
Further, two more patients post sotrovimab and ritonavir treatment had visited ED with symptoms of breathlessness and chest pain, respectively. However, both patients were discharged in good condition.
The authors of this study concluded that early treatment with SARS-CoV-2 monoclonal antibody and antiviral therapies was tolerated well in high-risk children and adolescents with COVID-19. Further COVID-19-related visits to ED or hospitalizations were less frequent in these patients.
Treatment of mild-to-moderate SARS-CoV-2 infection with monoclonal antibodies and antiviral therapies should only be considered in patients at increased risk of progression to severe disease.
The study has limitations such as its observational nature, small sample size at a single center, short follow-up duration, and the probability of non-reporting of all adverse events and outcomes in medical records.
medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.