Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial.

Background: Some studies suggested that adequate levels of vitamin D (VD) decrease the risk of severe COVID-19. Information about the effectiveness of VD supplementation in children is scarce. Objective: To assess the efficacy and safety of VD supplementation compared to the standard of care in hospitalized children with COVID-19. Patients and methods: An open-label randomized controlled single-blind clinical trial was carried out. We included patients from 1 month to 17 years, with moderate COVID-19, who required hospitalization and supplemental oxygen. They were randomized into two groups: the VD group, which received doses of 1,000 (children < 1 year) or 2,000 IU/day (from 1 to 17 years) and the group without VD (control). The outcome variables were the progression of oxygen requirement, the development of complications, and death. Statistical analysis: For comparison between groups, we used the chi-squared test or Fisher's exact test and the Mann-Whitney U test. Absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated. p ≤ 0.05 was considered statistically significant. Results: From 24 March 2020 to 31 March 2021, 87 patients were eligible to participate in the trial; 45 patients were randomized: 20 to the VD group and 25 to the control group. There was no difference in general characteristics at baseline, including serum VD levels (median 13.8 ng/ml in the VD group and 11.4 ng/ml in the control group). Outcomes: 2/20 (10%) in the VD group vs. 9/25 (36%) in the control group progressed to a superior ventilation modality (p = 0.10); one patient in the VD group died (5%) compared to 6 (24%) patients in the control group (p = 0.23). ARR was 26% (95% CI 8.8 to 60.2%) and NNT was 3 (2 to 11) for progression and ARR was 19% (95% CI -3.9 to 42.8%) and NNT was 6 (2 to 26) for death. None of the patients receiving VD had adverse effects. The trial was stopped for ethical reasons; since after receiving the results of the basal VD values, none of the patients had normal levels. Conclusion: In this trial, VD supplementation in pediatric patients seems to decrease the risk of COVID-19 progression and death. More studies are needed to confirm these findings. Clinical Trial Registration: This protocol was registered on ClinicalTrials.gov with the registration number NCT04502667.

Clinical presentation of pediatric patients with symptomatic SARS-CoV-2 infection during the first months of the COVID-19 pandemic in a single center in Mexico City

Background The clinical spectrum of COVID-19 is broad, from asymptomatic to severe cases and death. The objective of this study is to analyze the clinical course of patients attended during the first months of the SARS-CoV-2 pandemic in a third-level pediatric hospital. Methods Design: prospective cohort study. Patients with viral respiratory disease or suspected cases of COVID-19 were evaluated at the Pediatric Hospital, National Medical Center XXI Century, Mexico City, from 21 March 2020 to 13 January 2021. Statistical analysis: Chi-square test and Fisher’s exact test were used for comparisons;a logistic regression model was constructed to identify clinical or laboratory characteristics associated with critical disease. A p-value < 0.05 was considered statistically significant. Results A total of 697 patients met the operational definition of viral respiratory disease or suspected cases of COVID-19 and underwent real-time reverse transcription polymerase chain reaction (rRT-PCR) SARS-CoV-2 testing. Patients with a positive result were included. Of the 181 patients (26%), 121 (66.8%) had mild disease and were treated as outpatients and 60 (33.1%) were hospitalized. A total of six patients met the criteria for multisystem inflammatory syndrome in children (MIS-C). Of the 60 inpatients, 65% were males, and 82% had one or more comorbidities. The main comorbidities were cancer (42%) and overweight (15%). The median hospital stay was 9 days. The inpatients had a higher frequency of fever, general malaise, dyspnea, chills, polypnea, and cyanosis than the outpatients (p < 0.05). Only 21.4% of the outpatients had one or more comorbidities, which were lower than in the hospitalized patients (p < 0.001). Laboratory data at admission were similar between critically ill and those with moderate and severe disease. The patients who developed pneumonia were at higher risk of critical disease, while older age was associated with a better prognosis. A total of 13 of the 60 inpatients died (mortality 7.1%). All but one had one or more comorbidities: four had cancer, four congenital heart disease, one chronic kidney disease and epilepsy, one Epstein–Barr virus-induced hemophagocytic lymphohistiocytosis, one obesity, and one diabetes mellitus. Conclusion Hospital mortality is high, especially in children with comorbidities. Despite 2 years having passed since the beginning of the COVID-19 pandemic, the epidemiological and clinical data on children are still helpful to improve their prognosis.

Usefulness of High-Resolution Computed Tomography in Early Diagnosis of Patients with Suspected COVID-19.

BACKGROUND: Diagnosis of coronavirus disease 2019 (COVID-19) is mainly based on molecular testing. General population studies have shown that chest Computed Tomography (CT) can also be useful. OBJECTIVE: The study aims to examine the usefulness of high-resolution chest CT for early diagnosis of patients with suspected COVID-19. DESIGN AND SETTING: This is a cross-sectional study from May 1, 2020, to August 31, 2021, at the COVID Hospital, Mexico City. METHODS: This study examined the clinical, high-resolution chest CT imaging, and laboratory data of 160 patients who were suspected to have COVID-19. Patients with positive Reverse Transcription- Polymerase Chain Reaction (RT-PCR) testing and those with negative RT-PCR testing but clinical data compatible with COVID-19 and positive antibody testing were considered to have COVID-19 (positive). Sensitivity and specificity of CT for diagnosis of COVID-19 were calculated. p < 0.05 was considered significant. RESULTS: Median age of 160 study patients was 58 years. The proportion of patients with groundglass pattern was significantly higher in patients with COVID-19 than in those without COVID (65.1% versus 0%; P = 0.005). COVID-19 was ruled out in sixteen (11.1%). Only four of the 132 patients diagnosed with COVID-19 (3.0%) did not show CT alterations (p < 0.001). Sensitivity and specificity of CT for COVID-19 diagnosis were 96.7% and 42.8%, respectively. CONCLUSIONS: Chest CT can identify patients with COVID-19, as characteristic disease patterns are observed on CT in the early disease stage.

Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial.

BACKGROUND: Associations between vitamin D (VD) deficiency and the risk of SARS-CoV-2 infection have been documented in cross-sectional population studies. Intervention studies in patients with moderate to severe COVID-19 have failed to consistently document a beneficial effect. OBJECTIVE: To determine the efficacy and safety of VD-supplementation in the prevention of SARS-CoV-2 infection in highly exposed individuals. METHODS: A double-blind, parallel, randomized trial was conducted. Frontline healthcare workers from four hospitals in Mexico City, who tested negative for SARS-CoV-2 infection, were enrolled between July 15 and December 30, 2020. Participants were randomly assigned to receive 4,000 IU VD (VDG) or placebo (PG) daily for 30 d. RT-PCR tests were taken at baseline and repeated if COVID-19 manifestations appeared during follow-up. Serum 25-hydroxyvitamin D3 and antibody tests were measured at baseline and at day 45. Per-protocol and intention-to-treat analysis were conducted. RESULTS: Of 321 recruited subjects, 94 VDG and 98 PG completed follow-up. SARS-CoV-2 infection rate was lower in VDG than in PG (6.4 vs. 24.5%, p <0.001). The risk of acquiring SARS-CoV-2 infection was lower in the VDG than in the PG (RR: 0.23; 95% CI: 0.09-0.55) and was associated with an increment in serum levels of 25-hydroxyvitamin D3 (RR: 0.87; 95% CI: 0.82-0.93), independently of VD deficiency. No significant adverse events were identified. CONCLUSIONS: Our results suggest that VD-supplementation in highly exposed individuals prevents SARS-CoV-2 infection without serious AEs and regardless of VD status.

25-Hydroxyvitamin D level is associated with mortality in patients with critical COVID-19: a prospective observational study in Mexico City.

BACKGROUND/OBJECTIVES: Considering the high number of deaths from coronavirus disease 2019 (COVID-19) in Latin American countries, together with multiple factors that increase the prevalence of vitamin D deficiency, we aimed to determine 25-hydroxyvitamin D (25[OH]D) levels and its association with mortality in patients with critical COVID-19. SUBJECTS/METHODS: This was a prospective observational study including adult patients with critical COVID-19. Data, including clinical characteristics and 25(OH)D levels measured at the time of intensive care unit admission, were collected. All patients were followed until hospital discharge or in-hospital death. The patients were divided into those surviving and deceased patient groups, and univariate and multivariate logistic regression analyses were performed to determine independent predictors of in hospital mortality. RESULTS: The entire cohort comprised 94 patients with critical COVID-19 (males, 59.6%; median age, 61.5 years). The median 25(OH)D level was 12.7 ng/mL, and 15 (16%) and 79 (84%) patients had vitamin D insufficiency and vitamin D deficiency, respectively. The median serum 25(OH)D level was significantly lower in deceased patients compared with surviving (12.1 vs. 18.7 ng/mL, P < 0.001). Vitamin D deficiency was present in 100% of the deceased patients. Multivariate logistic regression analysis revealed that age, body mass index, other risk factors, and 25(OH)D level were independent predictors of mortality. CONCLUSIONS: Vitamin D deficiency was present in 84% of critical COVID-19 patients. Serum 25(OH)D was independently associated with mortality in critical patients with COVID-19.

Screening for COVID-19 in Children Undergoing Elective Invasive Procedures.

OBJECTIVE: To report the frequency of asymptomatic infection with SARS-CoV-2 in pediatric patients undergoing invasive medical procedures in a tertiary pediatric hospital. METHODS: From June to October 2020, a SARS-CoV-2 real-time reverse-transcription polymerase chain reaction (rRT-PCR) test was performed for all pediatric patients scheduled to undergo an elective invasive procedure. None of the patients was symptomatic. The cycle threshold (Ct) values of the ORF1ab gene were recorded for all patients. RESULTS: A total of 700 patients were screened for SARS-CoV-2 infection. The median age was 5.7 y old. In total, 46.6% (n = 326) of the patients were male, and 53.4% (n = 374) were female. The most common underlying diseases were hemato-oncological (25.3%), gastrointestinal (24.9%), and genitourinary (10.3%). The main scheduled surgical-medical procedures were surgical treatment for acquired congenital diseases, biopsy sampling, local therapy administration, organ transplantation, and the placement of central venous catheters, among others. The SARS-CoV-2 rRT-PCR test was positive in 9.4% (66), and the median Ct value was 35.8. None of the patients developed COVID-19. CONCLUSIONS: The frequency of asymptomatic SARS-CoV-2 infection was detected in less than 10% of pediatric patients scheduled to undergo an elective invasive procedure in a tertiary hospital. This frequency is higher than those in reports from different countries.