Background Protease inhibitor lopinavir/ritonavir has been used alone or in combination with other therapeutics as treatment of COVID-19. Data on paediatric population are scarce.
Objectives To assess efficacy and safety of lopinavir/ritonavir for treating paediatric patients with COVID-19.
Methods From March to August 2020, patients aged 18 years or below with confirmed COVID-19 diagnosed by positive SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) in their respiratory specimens in Department of Paediatrics, Queen Elizabeth Hospital and Princess Margaret Hospital, Hong Kong, were included. Patients were treated with lopinavir/ritonavir at decision of primary physician for 14 days or shorter when patient was fit for discharge or PCR in nasopharyngeal swab (NPS) turned negative. NPS viral load, which was determined by RT-qPCR targeting the RdRp-Hel gene, was obtained at different study time points. Clinical features including demographics, duration of symptom and hospitalization, time to negative PCR in NPS, need of oxygen therapy or intensive care were retrieved from medical records.
Results 80 patients admitted from March 2020 to August 2020 for COVID-19 were recruited. 27(33.8%) received lopinavir/ritonavir and 53(66.2%) patients received standard of care. Median age of patients in both groups were 8 years. Most patients have no co-morbidity. 16(59.3%), 8(29.6%) and 3(11.1%) patients in treatment group while 33(62.3%), 20(37.7%) and none of patients in control group have upper respiratory infections, asymptomatic infection and pneumonia respectively. The median days from symptom onset to admission was 1 (IQR 0–2) in treatment and 3(IQR 1–5) in control group. The median days from symptom onset to start of lopinavir/ritonavir was 1(IQR 1–3). The NPS viral load reduction from baseline to day 7 was greater in treatment group. Viral load dropped from mean 6.5 log10 copies/ml (SD 2.1) on admission to mean 4.6 log10 copies/ml (SD 2.1) on day 7 in patients treated with lopinavir/ritonavir. Viral load dropped from mean 6.4 log10 copies/ml (SD 1.8) on admission to mean 5.3 log10 copies/ml (SD 1.5) on day 7 in patient who did not receive lopinavir/ritonavir. However, the difference was not statistically significant. There was no significant difference in viral load on day 10 and day 14 between the two groups. There was also no significant difference in time to symptom resolution, PCR negativity or duration of hospitalization. No patient in the cohort require oxygen or intensive care. Among those received treatment, 7(25.9%) patients experienced gastrointestinal symptoms possibly drug adverse effects with self-limited nausea, vomiting or diarrhea, as compared to 9(17%) patients in control group. 1(3.7%) and 3(5.7%) patients in treatment and control group have mild deranged liver function. There was no significant difference in rate of gastrointestinal symptom or liver function derangement among the two groups. There was no QT interval prolongation or serious adverse effect noted in patients received treatment.
Conclusions There was no statistically significant difference in NPS viral load clearance, time to symptom resolution, PCR negativity and duration of hospitalization between paediatric COVID-19 patients treated with lopinavir/ritonavir and control. Self-limited gastrointestinal symptoms were common but use of lopinavir/ritonavir appeared to be safe in children with no serious side effect noted.
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