ABSTRACT
Background: Recent studies suggest that baricitinib added to dexamethasone may reduce mortality in hospitalized COVID-19 patients requiring supplemental oxygen Methods: In a multicenter open-label, pragmatic, randomized clinical trial in 25 hospitals in Spain we included symptomatic participants with SARS-CoV-2 detected by PCR or antigenic test, with a creatinine clearance >60 mL/min, > 60 years or younger if they had at least two comorbidities (hypertension, obesity, diabetes, cirrhosis, chronic neurologic disease, active cancer, heart failure, coronary heart disease or COPD). Participants were initially randomized to receive or not tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). At any moment during the trial participants with room air 02 saturation < 95% and at least one increased inflammatory biomarker could be randomized to dexamethasone (D) or dexamethasone plus baricitinib (DB). Primary outcome was 28 days mortality. Secondary outcomes were disease progression (increase of O2 requirements, mechanical ventilation or increase in medical therapy: steroid dose, need for starting tocilizumab) Results: Out of the 355 participants included in the trial 287 (80.8%) were randomized to D (n=142) or DB (n=145), 264 (91.9%) simultaneously with the TDF/FTC randomization and 23 (8.1%) later on. Median age 67 years (IQR 62, 73), male (65.5%), with median 8 days of symptoms (IQR 5-10), 28.6% with ≤ 5 days of symptoms, 100% hospitalized, 31.6% with one and 38.7% with ≥ 2 comorbidities (most common: 35.9% hypertension, 9.4% diabetes, 1.7 % obesity), 14.3% receiving remdesivir and 49.1% TDF/FTC. Endpoints in participants treated with D vs. those treated with DB favored DB without achieving statistical significance: mortality 4.9%/2.1%, disease progression 27.5%/24.8%, mechanical ventilation (invasive or noninvasive) 25.4%/23.4%, days since randomization until discharge (median [IQR]) 7 [5, 12]/7 [5, 13.5], discharge before 28 days 89%/94.2%. By Cox regression Hazard Ratio (95% CI) of 28-day mortality was 0.51 (0.13-2.06) for participants treated with DB. Serious adverse events occurred in 9.9%/9.7% of participants treated with D or DB respectively. Adverse events leading to B discontinuation occurred in 3.45% of participants. Conclusion: In this clinical trial of high-risk patients with COVID-19 all disease outcomes favored baricitinb added to dexamethasone but differences did not reach statistical significance. Overall mortality was unexpectedly low.
ABSTRACT
Background: For newly diagnosed persons with HIV (PWH), early initiation of ART is essential in reducing morbidity and mortality and decreasing the risk of transmitting HIV. We have previously reported the trends in linkage to HIV medical care within one month of HIV diagnosis (LC-1Mo) and viral suppression within three months of HIV diagnosis (VS-3Mo) among PWH in Spain from 2004 to 2018. We herein update this information up to 2020. Methods: Longitudinal study based on the Cohort of the Spanish AIDS Research Network (CoRIS). VS was defined as ever having an HIV-RNA <200 copies/mL. We used logistic regression to assess differences by sex, age, country of birth, transmission category, and baseline CD4+ cell count. Results: A total of 13,632 PWH were enrolled in CoRIS in the study period: males 85%, men having sex with men (MSM) 62%, median age 35 (IQR: 28-43) years. LC-1Mo increased from 41% (95% CI, 37%-45%) in 2004 to 83% (79%-87%) in 2020 (P trend <0.001) (Figure). Median CD4+ cell counts at ART initiation increased from < 250/mm3 in 2004-2005 to > 350/mm3 since 2012 (P for trend <0.001). The percentage of initial ART regimens based on integrase strand transfer inhibitors (InSTI) increased from 3% in 2004 to > 70% from 2016 onwards (P trend <0.001). VS-3Mo increased from 6% (4%-8%) in 2004 to 43% (40%-47%) in 2019 with a small decrease to 41% (36%-46%) in 2020 (P trend [for the entire period] <0.001) (Figure). The odds of achieving VS-3Mo was higher among females (aOR, 95% CI: 1.30, 1.12-1.51), among non-Spanish Europeans and Latin Americans compared to native-born Spaniards (1.26, 1.11-1.44 and 1.36, 1.21-1.52, respectively), and among those older than 50 years (1.20, 1.03-1.41). Opposite, the odds of achieving VS-3Mo was lower among IDU compared to MSM (0.53, 0.40-0.70) and those with CD4 counts between 200-500 cells/uL (0.78, 0.69-0.89) and CD4 counts >500 cells/uL (0.51, 0.44-0.60) compared to those with CD4 < 200 cells/uL. Conclusion: Indicators of care have improved among newly diagnosed PWH in Spain over the last 16 years. Elimination of CD4 cell count restrictions for ART initiation and increasing use of InSTI-based regimens was decisive for progress. A slight decrease in VS-3Mo in 2020 compared with 2019 was observed, perhaps because of the COVID-19 pandemic.
Subject(s)
COVID-19/complications , Olfaction Disorders/epidemiology , SARS-CoV-2 , Taste Disorders/epidemiology , Adolescent , Child , Child, Preschool , Female , Humans , Infant , Male , PrevalenceABSTRACT
Rationale: The specific chest X-ray (CXR) abnormalities in pediatric COVID19 and their relation to clinical outcomes remain to be defined. Addressing this gap is important given the age-related differences in the clinical and imaging features of COVID-19 and the challenge of differentiating SARS-CoV-2 infections from other types of viral lower respiratory infections (LRTIs) in young children. Methods: We conducted a single-center crosssectional study that included a sample of children, adolescents, and young adults (0-25 years) who had a (+) PCR test for SARS-CoV-2 and a CXR. We also included a random sample of young children (0-2 years, n=68) diagnosed with PCR-confirmed viral LRTI during 2018-2019 to compare CXR features with those seen in pediatric COVID-19. Results: A total of 422 pediatric COVID19 cases were identified during the study period. We enrolled 104 individuals with (+) PCR for SARS-CoV-2 and available CXR and sub-divided them according to age groups including young children (0-2 years, n=27), school-age children (3-10 years, n= 27), adolescents (11-18 years, n=41) and young adults (19-25 years, n=9). Overall, 52 (50%) of pediatric patients with COVID-19 were hospitalized and 26 (25%) required admission to PICU. The most common imaging abnormality identified was the presence of ground-glass opacifications (GGO)/focal consolidations (36%). The presence of GGO/consolidation was affected by age being more common among young adults (44%). Individuals requiring hospitalization or ICU admission had significantly more GGO/opacities in CXR (p<0.05). Typical lung imaging features of viral respiratory infections in the pediatric population such as increased perihilar markings and hyperinflation were more common in non-COVID-19 viral LRTI cases than in SARS-CoV-2 infection in young children (p<0.05) Conclusions: Chest X-ray imaging is a useful non-invasive tool to evaluate lung compromise in pediatric COVID-19 cases. The severity of GGO/consolidations is predictive of clinically relevant outcomes (e.g. hospitalization). Hyperinflation/perihilar markings could potentially aid in distinguishing COVID-19 from other types of viral LRTI in young children.
ABSTRACT
Background: We compared the characteristics and clinical outcomes of hospitalized patients with COVID-19 with and without HIV infection (HIV-pos and HIV-neg) in Spain during the first wave of the pandemic. Methods: HIV-pos were identified by reviewing clinical records and laboratory registries of 10,922 patients in active-follow-up within the Spanish HIV Research Network (CoRIS) up to June 30, 2020. Each HIV-pos was matched with 5 HIV-neg of the same age and sex randomly selected from COVID-19@Spain, a multicenter cohort of 4,035 patients hospitalized with PCR confirmed COVID-19 in Spain (Clin Microbiol Infect 2020;26:1525-36). Data were collected with the ISARIC-WHO Core case report form (https://isaric.org/document/COVID-19-crf/). The COVID-19 SEIMC score (predictive of 30-day mortality), based on age, sex, dyspnea, O2 saturation, neutrophil-to-lymphocyte ratio, and estimated glomerular filtration rate, was calculated at admission in all patients (ESCMID Conference on Coronavirus Disease, 2020, Abstract#00513). Outcomes included the need for mechanical ventilation and all-cause in-hospital mortality. Results: Forty-five patients with PCR confirmed COVID-19 were identified in CoRIS, 21 of which were hospitalized. A total of 105 age/sex-matched controls were selected from COVID-19@Spain. The median age in both groups was 53 (Q1-Q3, 46-56) years, and 90.5% were men. In HIV-pos, 19.1% were IDUs, 95.2% were on ART, 94.4% had HIV-RNA < 50 copies/mL, and the median (Q1-Q3) CD4+ count was 595 (349-798) cells/mm3. No statistically significant differences were found between groups in number and type of comorbidities, presenting signs and symptoms, laboratory parameters, and radiology findings. The median (Q1-Q3) COVID-19 SEIMC score on admission was 4 (2-7) and 5 (3-7) in HIV-pos and HIV-neg, respectively;P=.890. Corticosteroids were administered to 33.3% and 27,4% HIV-pos and HIV-neg, respectively;P=.58. Remdesivir was administered to 0 and 2.9% of HIV-pos and HIV-neg, respectively;P=.426. During admission, 9.5% HIV-pos and 23.3% HIV-neg underwent mechanical ventilation;P=.158. In-hospital mortality was 9.5% in HIV-pos and 11.4% in HIV-neg;P=.800. Conclusion: Our findings suggest that well-controlled HIV infection does not modify the clinical presentation or worsen clinical outcomes in patients hospitalized with COVID-19. (Figure Presented).
ABSTRACT
Background: Within a prospective cohort of people with HIV (PWH) in Spain, we assessed the prevalence of SARS-CoV-2 antibodies (Ab), the proportion of asymptomatic COVID-19, and identified predictors of infection. Methods: We determined SARS-CoV-2 Ab in plasma samples collected from April 1st to September 30th, 2020, from enrollees in the Spanish HIV Research Network Cohort (CoRIS), a prospective national cohort of PWH, naive to ART at study entry, seen for the first time from January 1st, 2004. Samples were stored at-80°C in the Spanish HIV BioBank, and serology was performed using the Platelia SARS-CoV-2 Total Ab assays (BioRad, Hercules, CA, USA). Illness severity (NIH criteria) was assessed by medical records review and, if needed, participant interviews. Multivariable logistic regression analysis was used to identify predictors of seropositivity among the following variables: sex, age, country of birth, education level, comorbidities (hypertension, chronic heart disease, diabetes, non-AIDS related cancer, chronic kidney disease, cirrhosis), route of HIV acquisition, prior AIDS, CD4+ cell count, HIV viral load, and N(t)RTI backbone. Results: During the study period, blood samples were collected and stored in the HIV BioBank from 1,076 consecutive PWH in CoRIS: 88.0% male at birth, median age 43 yr., 72.3% MSM, 97.7% on ART, median CD4+ 688 cells/mm3, 91.4% undetectable HIV viral load. SARS-CoV-2 Ab were detected in 91 PWH, for a seroprevalence of 8.5% (95%CI: 6.9%-10.3%). A total of 41 PWH (45.0%) had asymptomatic infections;the disease was mild in 43 (47.3%), moderate in 4 (4.4%), severe in 3 (3.3%), and 0 critical. Seven PWH (7.7%) were hospitalized. COVID-19 was confirmed by RT-PCR in 22 (24.2%) PWH. Variables independently associated with SARS-CoV-2 seropositivity were birth in Latin American (LA) Countries vs. Spain (adjusted odds ratio [aOR]: 2.34, 95%CI: 1.42-3.85;P=.001);arterial hypertension (aOR: 1.63, 95%CI: 1.00-2.67;P=.050);and therapy with tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) vs tenofovir alafenamide (TAF)/FTC as the N(t)RTI backbone (aOR: 0.32, 95%CI: 0.12-0.84;P=.021). (Table). Conclusion: A large proportion of SARS-CoV-2 infections among PWH were asymptomatic. Birth in LA-countries and arterial hypertension were associated with increased risk of SARS-CoV-2 seropositivity. Our analysis, adjusted by comorbidities and other variables, suggest that TDF/FTC may prevent SARS-CoV-2 infection among PWH. (Figure Presented).