Remdesivir has been safely used to treat an infant with severe COVID-19-related acute respiratory distress syndrome (ARDS), according to a case report.
Remdesivir has shown promise for treating adults infected with SARS-CoV-2, but there are no previous reports of children with COVID-19 treated with the drug.
Dr. Alasdair Bamford of Great Ormond Street Hospital for Children NHS Trust in London and colleagues describe their experience using remdesivir to treat a five-week-old infant who had been born premature and presented with SARS-CoV-2 infection.
One of twins, the boy developed respiratory distress at home where he had been in recent contact with both family members and asymptomatic healthcare workers who subsequently developed symptoms and were confirmed to have a SARS-CoV-2 infection. Nasopharyngeal aspirate of the infant tested positive for SARS-CoV-2 RNA.
In the emergency department, several attempts at intubation to treat progressive hypoxia failed, but he was successfully intubated after transfer to a quaternary center. After several days, his ventilation parameters improved and he was deemed suitable for a trial of extubation.
After prophylactic steroids to optimize laryngeal conditions for extubation, but before extubation, the patient deteriorated, developing fulminant ARDS, the authors report in Pediatrics.
Conventional ventilation was no longer sufficient, so the infant was treated with high-frequency oscillatory ventilation, nitric oxide, prone ventilation, and inotropic support to maintain oxygenation and ventilation.
At this point, an urgent multidisciplinary meeting was held to consider additional treatment, and a compassionate access application for remdesivir was agreed on and was granted following a mandatory second opinion from another institution.
The infant received a loading dose of 5 mg/kg remdesivir, followed by 1.25 mg/kg daily maintenance doses for 10 days.
Tracheal aspirates became negative for SARS-CoV-2 RNA after five days of treatment with remdesivir (excluding an isolated positive result on day 10 of treatment, tests through hospital day 24 remained negative).
There was no evidence of toxicity associated with remdesivir treatment.
Ventilatory and inotropic support were weaned, extubation was successful on day 18 of illness, and the boy was discharged on day 24.
“This information provides urgent first data to inform the treatment of children presenting with SARS-CoV-2 disease as the pandemic affects children across the globe,” the authors conclude.
Dr. Hanna Wardell of Boston Children’s Hospital and Harvard Medical School, who recently reported a series of four full-term neonates infected with SARS-CoV-2, told Reuters Health by email, “As we continue to await pediatric clinical trial data, case reports such as this one contribute to our understanding of the spectrum of disease severity in children, therapeutic management, and, significantly, evidence of novel drug (remdesivir) tolerability in the neonatal age group.”
“Fortunately, most SARS-CoV-2 infections in pediatric patients are mild or asymptomatic, but infants have been noted to be a higher-risk group,” she said. “Since the majority of ill or febrile neonates require hospitalization for evaluation of serious bacterial infections, even mild symptoms from SARS-CoV-2 infection can carry significant repercussions. In those with more significant symptoms, the short- and long-term outcomes of infants with COVID-19 are still being elucidated, especially in the context of MIS-C (multi-system inflammatory syndrome in children).”
“Extrapolating from the promising results of numerous clinic trials in adults with COVID-19, remdesivir is considered the first-line therapeutic in pediatric patients hospitalized with SARS-CoV-2 infection, as well,” said Dr. Wardell, who was not involved in the new report. “While the risk-benefit assessment of which pediatric patients to treat and at what points in their illness courses might differ somewhat from that assessment in adult patients, I would say the standard of care is moving towards considering remdesivir in every pediatric patient with severe symptoms.”
“Thus far,” she added, “only anecdotal reports suggest the drug is well tolerated in infants and children. Crucial pediatric clinical trials are currently underway around the globe to establish the efficacy, safety, and pharmacokinetics of remdesivir in infants and children so more evidence-based risk-benefit assessments can be made to determine in whom and when to treat.”
“The infant reported in this case was noted to have contact with asymptomatically infected family members and healthcare workers, underscoring the household and asymptomatic transmission commonly noted in epidemiologic pediatric studies,” Dr. Wardell said. “This highlights the importance of considering the unique vulnerabilities of infants and children as we develop realistic strategies to mitigate community transmission.”