ABSTRACT
Background: Long term evolution of Multisystem Inflammatory Syndrome in children (MIS-C) is poorly understood. In this report, we described the frequency of persistent symptoms and sequels after one-year monitoring in a cohort of MIS-C patients. Method(s): This is a prospective observational study in under-18-aged patients diagnosed with MIS-C between October 2020 and April 2021 in a tertiary hospital. Data from initial episode was obtained from the Spanish national database and the medical history. A standardized phone questionnaire was done one year after the acute episode. As patients pared by age and sex were included with i) history of acute COVID-19, from the same national database, and ii) with peritonitis diagnosis in the electronic medical record. Data was collected using REDCap and analysed with R. Ethics committee approval was obtained. Result(s): A total of 48 patients were included in the study, 16 in each group. Average age at hospitalization was 11,2 years old [IQR: 6,6-14,4] and 52% (23/48) were male. MIS-C patients presented high frequently 94% (15/16) cardiological complications during hospitalization, in contrast with 19% (3/16) of acute COVID-19 patients and 25% (4/16) of peritonitis group (p< 0.01). All of them resolved after a year except the ones associated to hypoxic ischemic encephalopathy in a patient with MIS-C that need ECMO assistance. Summary characteristics during acute episode are shown in Table 1. After one-year follow-up, 88% MIS-C patients suffered one or more symptoms, more frequently: headache (44%), fatigue (38%), insomnia (38%) and concentration problems (38%). A total of 56% of COVID-19 patients presented persisted symptoms, mainly fatigue and concentration problems (19%), and 31% in peritonitis group (19% loss of appetite and abdominal pain), (p< 0.001). MIS-C patients visited more frequently the medical professionals due to emotional change, behaviour or interpersonal relationships after the disease [4/16 (25%) in MIS-C vs. 0/16 (0%) in both control groups, p= 0.028]. Conclusion(s): Majority of MIS-C patients have persistent symptoms one year after acute episode, even with the resolution of cardiological complications. Frequency of long term symptoms in MIS-C patients is significantly higher than in COVID-19 hospitalized and than in a control group of surgical peritonitis patients. Summary characteristics during acute episode.
ABSTRACT
P168 Table 1Overall safety showing proportion of participants with AEsParticipants, n (%) Cohort 1n=12 Cohort 2n=12 Cohort 3n=12 Cohort 4n=12 Cohort 8n=5 TotalN=53 Any AE 11 (92) 7 (58) 9 (75) 7 (58) 4 (80) 38 (72) Grade ≥3 AE 6 (50) 2 (17) 1 (8) 4 (33) 2 (40) 15 (28) SAE 5 (42) 2 (17) 0 3 (25) 1 (20) 11 (21) Treatment discontinuation due to AE 2 (17) 0 0 0 0 2 (4) Treatment-emergent death 1 (8) 1 (8) 0 0 1 (20) 3 (6) Grade 3–4 laboratory abnormalities 9 (75) 2 (17) 4 (33) 4 (36) 3 (60) 22 (42) ConclusionsRDV was generally well tolerated in children hospitalised for COVID-19 who were 28 days and older, weighing at least 3 kg. No new safety trends for RDV were identified and a high proportion of participants had clinical improvement. CARAVAN is ongoing for enrolment of full term and preterm neonates.
ABSTRACT
Background: Remdesivir (RDV) has been shown to shorten time to recovery in hospitalized adults with COVID-19. Some children who develop COVID-19 require hospitalization. Here we characterize the safety profile of RDV in 53 pediatric patients age 28 days to <18 years and describe clinical and virologic outcomes. Methods: CARAVAN (NCT04431453) is an ongoing open-label, single arm study of RDV in hospitalized patients <18 years with PCR-confirmed COVID-19. IV RDV was given for up to 10 days: 200mg on Day 1 followed by 100mg daily in Cohort 1 and 8 (<18y, weight ≥40kg) or 5mg/kg on Day 1 followed by 2.5mg/kg daily in Cohorts 2-4 (28 days to <18y, stratified by weight). Safety was assessed by adverse events (AEs) and lab tests (hematology, chemistry, urine, inflammatory, coagulation). Clinical outcomes included improvement on a 7-point ordinal scale, time to discharge, and oxygenation modality. Virologic outcomes included days to confirmed negative SARS-CoV-2 PCR (defined as 2 consecutive negative results). Results: At enrollment, median (IQR) age was 7y (2, 12) and weight was 24.6 (12.8, 55.1) Kg, 57% were female, 76% required supplemental oxygen, including 23% on invasive ventilation and 34% on high-flow oxygen (Table). Median number of RDV doses was 5 (4,8). Most patients (72%) experienced ≥1 AE;most common was constipation (17%). Serious AEs were reported for 21% of patients and none were study-drug related. Two patients with baseline transaminitis had non-serious AE of increased ALT contributing to premature discontinuation. Two patients died within the 30-day study period. Grade ≥ 3 lab abnormalities were reported in 42%;most common being decreased haemoglobin (n=9) and decreased eGFR levels (n=7). No safety trends related to RDV were apparent. In total, 85% showed clinical improvement on the 7-point ordinal scale by last assessment. Median (IQR) time to discharge was 8 (5, 17) days. By last assessment, 8% required supplemental oxygen, all of whom were invasively ventilated. Time to confirmed negative SARS-CoV-2 PCR CoV-2 PCR was 5 and 7 days from nasal/oropharyngeal samples in cohort 2 and 3, respectively, and not estimable in the other cohorts. Conclusion:RDV was safe and well tolerated among children 28 days to <18y treated for COVID-19. Overall, no safety trends for RDV were apparent and a high proportion, 85%, had clinical improvement. The study is ongoing with enrolment of full term and preterm neonates pending dose determination.
ABSTRACT
Background: The COVID-19 pandemic has emerged as the most important international health problem of the last decades. This study explores the psychopathological implications that Covid-19 has caused on cancer patients during the first wave of the pandemic in Spain. Methods: In this prospective study, we included cancer patients in active treatment from March to June 2020. A 24-question semi-structured questionnaire was designed to measure baseline demographic, clinical and Covid-19 exposure characteristics. Mental health was assessed using the validated Hospital Anxiety and Depression Scale. A descriptive and analytical univariate analysis of the variables studied was performed. Results have been compared with baseline emotional distress rates from historical cohorts in cancer patients. Results: 104 cancer patients were included;a 52.8% of emotional distress, 42.3% of anxiety and 58.6% of depression were detected. 51% of patients expressed higher concern about cancer diagnosis vs COVID-19 infection. Tumor type, stage, type of oncologic treatment or rescheduling of cancer therapy were not related with higher levels of psychological symptomatology. Patients with previous consumption of psychotropic drugs and those who adopted additional infection prevention measures because they considered themselves at risk of having a more aggressive COVID-19 disease had higher levels of emotional distress (p=0.008;p=0.003), anxiety (p=0.026;p=0.004) and depression (p=0.013;p=0.008). Emotional distress was higher in patients whose financial status had worsened (p=0.002). Anxiety rates were higher among patients who often used relaxing therapies (p=0.011) and those who were frequently exposed to media (p=0.05). Depression rates were higher among patients with lower educational level (p=0.032), in those whose economic situation had worsened (p=0.003), and those who relied on Religion or Faith (p=0.029). Conclusions: High rates of emotional distress have been detected during the first wave of the Covid-19 pandemic among cancer patients in active treatment, however, not higher than expected in this population. The cancer disease itself continues to be the main factor of concern for cancer patients, above and beyond the distress generated by Covid-19 pandemic. Legal entity responsible for the study: Hospital Universitario De La Princesa, Medical Oncology Department. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background: COVID-19 is generally a mild disease in children and infants. However, a small proportion develop severe disease requiring intensive care and ventilatory support. Remdesivir (RDV), a direct-acting nucleotide pro-drug inhibitor of viral RNA-dependent RNA polymerases, has been shown to shorten time to recovery in adults with severe COVID-19. The aim of this study is to evaluate the safety and efficacy of RDV in pediatric patients. Methods: CARAVAN (NCT04431453) is an ongoing open-label study of RDV in hospitalized pediatric patients with PCR-confirmed COVID-19. IV RDV is given for up to 10 days: 200mg on Day 1 followed by 100mg daily in Cohort 1 (12 to <18y, weight ≥40kg) or 5mg/kg on Day 1 followed by 2.5mg/kg daily in Cohorts 2-4 (28 days to <18y, stratified by weight). Safety is assessed by adverse events (AEs) and laboratory tests. Efficacy assessments include change in oxygen requirements and clinical status on a 7-point ordinal scale through Day 10. Results: Preliminary results for the first 27 patients are presented. Median (range) age and weight were: Cohort 1, 15 (12-17)y and 84 (47-192)kg;Cohort 2, 8 (4-16)y and 27 (25-39)kg;Cohort 3, 3 (2-5)y and 16 (12-18)kg;Cohort 4, 6 (2-11)m and 7 (3-10)kg. Overall, 52% were <12y, 56% were female, and 96% had ≥1 comorbid medical condition. Median number of RDV doses was 5;most RDV discontinuations were due to clinical improvement. At baseline, 67% required supplemental oxygen, including 22% on invasive ventilation;at Day 10, the values were 26% and 15%, respectively. In total, 70% showed clinical improvement on the 7-point ordinal scale at Day 10. Most (78%) had ≥1 AE, including 17% with study drug-related AEs;7% discontinued study drug due to an AE. Serious AEs were reported for 33% of patients;no SAEs were study drug related. Two patients died within 30 days of completing treatment. Grade 3 or 4 lab abnormalities were reported in 52%;those reported in ≥1 patient were decreased hemoglobin (n=5), and hypoglycemia, glycosuria, and increased PTT (n=2 each). No safety trends related to RDV were apparent. Conclusion: Among pediatric patients aged 2m to 17y treated with RDV for COVID-19, 70% had clinical improvement. The study is ongoing;enrolment of full term and preterm neonates is pending determination of the dose to be evaluated.