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1.
Gastroenterology ; 162(7):S-600-S-601, 2022.
Article in English | EMBASE | ID: covidwho-1967348

ABSTRACT

Background This study aimed to compare the risk of COVID-19 in patients with IBD versus the general population, and to evaluate predictors of infection acquisition, progression to severe forms, and risk of developing persistent COVID-19. We also assess the differences between cases across the different COVID-19 pandemic waves in our target population. Methods This single-center prospective, cohort study included consecutive IBD patients diagnosed of COVID-19 either by a positive polymerase chain reaction test and/or antigen test in nasopharyngeal swabs, or by anti-SARS-CoV-2 antibodies, and that they had a followup of at least 4 months. Using logistic regression, we evaluated cases versus IBD controls included in the IBD Unit database for predictors of COVID-19 acquisition. COVID-19 cases were distributed according to pandemic waves. Cox regression analysis was used for predictors of severe and persistent COVID-19. Results By May 31, 2021, 160 out of 1911 IBD patients (8.3%) were diagnosed with COVID-19. IBD patients had a similar adjusted incidence of COVID-19 (OR 0.94;95% CI 0.86-1.02;P=0.42), and a similar associated mortality ratio (OR 0.83;95% CI 0.6-1.06;P=0.48), compared to the general population. In multivariable analysis, treatment with biologics was associated with a higher risk (OR 2.22, 95% CI 1.54-3.2, P<0.001), and treatment with salicylates with a lower risk (OR 0.71, 95% CI 0.50-0.99, P=0.048) of contracting COVID-19. Sixty-two COVID-19 cases were diagnosed during the first wave of pandemic (until the end of June 2020), and 54 and 44 cases during the second and third waves (until the end of December 2020 and May 2021, respectively). (Figure 1) In multivariate analysis, first wave cases were associated with a higher risk of progression to severe forms of infection (OR 4.76, 95% CI 1.83-12.37, P= 0.001), and development of persistent COVID-19 (OR 2.4, 95% CI 1.16-4.95, P=0.018). Twenty-nine patients (18.1%) required hospitalization and were classified as severe COVID- 19, which was associated in multivariable analysis with age>48 (HR 3.68, P=0.007), cases diagnosed in the first wave (HR 6.04, P<0.001), and comorbidities (evaluated with Duke Severity of Illness Checklist [DUSOI], P<0.001). (Table 1) During a median follow-up of 8.4 months, 68 patients (42.5%) were diagnosed with persistent COVID-19. Multivariable analysis identified UC (OR 2.00, 95% CI 0.99-4.03, P=0.053), comorbidities (P=0.090), and being diagnosed during the first wave (OR 2.48, 95% CI 1.23-5.00, P=0.011) as risk factors for persistent COVID-19. Conclusion IBD patients have a similar risk of COVID- 19 and associated mortality as the general population. Cases diagnosed during the first wave of the pandemic had severe and persistent forms of COVID-19 more frequently. Age and comorbidity were the main risk factors for severe forms of the disease. (Figure Presented) (Table Presented)

2.
Farmacia Hospitalaria ; 46(3):166-172, 2022.
Article in Spanish | Web of Science Web of Science | ID: covidwho-1884660

ABSTRACT

Objective: One year after the declaration of the SARS-CoV-2 pandemic, only dexamethasone has clearly shown a reduction in mortality for COVID-19 hospitalized patients. For interleukin-6 inhibitors, results are variable and unclear. The objective was to review and analyze the effect of tocilizumab and sarilumab on survival in this setting. Method: The PRISMA statements were fulfilled for the systematic review. A systematic search in Medline, Embase and medRxiv was conducted to identify randomized controlled trials with tocilizumab or sarilumab in hospitalized patients with COVID-19. Mortality data from non-critical and critical patients were extracted. A random-effects (DerSimonian-Laird) meta-analysis was performed for both subgroups and the whole population using MAVIS software v. 1.1.3. Similarity and homogeneity among trials were assessed. Results: Twenty- five and 23 articles were identified in Medline and Embase, respectively, five were trials with tocilizumab and/or sarilumab;two more were identified at medRxiv. Seven randomized clinical trials fulfilled the inclusion criteria. Another trial was pre-published and included post-hoc. The meta-analysis, with eight randomized clinical trials and 6,340 patients, showed a benefit on mortality for interleukin-6 inhibitor (hazard ratio 0.85;confidence interval 95% 0.74-0.99), low heterogeneity (I-2 = 7%), but a low similarity among studies. The results showed no differences among critical and non- critical patients. A sensitivity analysis excluding non-similar or heterogeneous studies showed different results, without benefit and with low precision of the result in non- critical patients. Conclusions: A benefit in mortality for interleukine- 6 inhibitors was found, but with important differences among the scenarios analyzed in the clinical trials. Positive results are mainly caused by two randomized clinical trials which are similar in concomitant use of steroids and veryhigh mortality in critical patents. Sarilumab was poorly represented in the meta-analysis. Nevertheless, an association between the benefit and the critical/non-critical condition was not found. More randomized clinical trials, mainly focused in patients at high mortality risk, are needed to confirm the benefit of interleukine-6 inhibitors for COVID-19. Sarilumab was underrepresented in the meta-analysis.

3.
Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria ; 46(2):57-71, 2022.
Article in English | Scopus | ID: covidwho-1787352

ABSTRACT

OBJECTIVE: To determine the baseline characteristics associated with higher  mortality at 42 days in patients hospitalized for COVID-19 in Spain. METHOD: The study analyzed a prospective cohort of hospitalized COVID-19  patients. The dependent variable was 42-day mortality. Data on the subjects'  demographic and clinical characteristics, comorbidities, usual therapy and  supportive interventions and treatments was collected within 48 hours from  admission. To determine the potential association of the data with mortality, a  multivariate analysis was performed using logistic regression. RESULTS: 15,628 patients were included, 18.2% of whom (n = 2,806) died  during the study period. According to the multivariate analysis, the variables  that were significantly associated (p < 0.05) with mortality upon admission  were: being referred from a nursing home (OR 1.9);having a high respiratory  rate (OR 1,5);having moderate (OR 1.7) or severe (OR 2.9) pneumonia  (CURB-65);aspartate aminotransferase transaminase ≥ 100 IU/l (OR 2.1);  lactate dehydrogenase ≥ 360 IU/L (OR 1.6);procalcitonin > 0.5 ng/mL (OR  1.8);creatine kinase ≥ 294 U/L (OR 1.5);D-dimer > 3,000 ng/mL (OR 1.5);  hemoglobin < 11.6 g/dL (OR 1.4) and C-reactive protein > 120 mg/L (OR 1.2;  requiring respiratory support within the first 48 hours (oxygen therapy [OR  2.0], non-invasive ventilation [OR 2.8], and mechanical ventilation [OR 3.5]);  and being treated with interferon-beta (OR 1.5). On the contrary, being under  80 years of age was associated with lower mortality. CONCLUSIONS: The analysis, based on the data in the RERFAR registry, showed that the factors associated with poorer prognosis were older age,  assessed using the CURB-65 scale, level of respiratory support required,  severe pneumonia (CURB-65), hypertransaminasemia, elevated creatine  kinase, lactate dehydrogenase, and D-dimer levels, anemia, and elevated  respiratory rate. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved. OBJETIVO: Determinar las características basales que se asocian a una mayor  mortalidad a los 42 días en aquellos pacientes hospitalizados por COVID-19 en  España.Método: Cohorte prospectiva de pacientes COVID-19 hospitalizados. La  variable dependiente fue la mortalidad a los 42 días. Además, se recogieron  características demográficas, clínicas, comorbilidades, tratamiento habitual,  intervenciones de soporte y tratamientos en las primeras 48 horas del ingreso.  Para determinar la asociación con la mortalidad, se realizó un análisis  multivariante mediante regresión logística. Resultados: Se incluyeron 15.628 pacientes, de ellos falleció el 18,2% (n =  2.806). El análisis multivariante mostró que las variables asociadas significativamente (p < 0,05) con la mortalidad al ingreso fueron:  proceder de un centro sociosanitario (odds ratio OR 1,9), frecuencia  respiratoria (odds ratio 1,5), gravedad de neumonía (CURB-65) moderada  (odds ratio 1,7) o alta (odds ratio 2,9), transaminasa aspartato  aminotransferasa ≥ 100 UI/l (odds ratio 2,1), lactato-deshidrogenasa ≥ 360  UI/l (odds ratio 1,6), procalcitonina > 0,5 ng/ml (odds ratio 1,8), creatina- quinasa ≥ 294 U/l (odds ratio 1,5), dímero D > 3.000 ng/ml (odds ratio 1,5),  hemoglobina < 11,6 g/dl (odds ratio 1,4) y proteína C reactiva > 120 mg/l  (odds ratio 1,2), necesidad de soporte respiratorio en las primeras 48 horas  (odds ratio 2,0 de oxigenoterapia;odds ratio 2,8 ventilación no invasiva y odds ratio 3,5 ventilación mecánica) y tratamiento con interferón-beta (odds ratio  1,5). Por el contrario, ser menor de 80 años se asoció a una menor mortalidad. Conclusiones: El análisis del Registro Español de Resultados de  farmacoterapia frente a COVID-19 muestra que los factores asociados a peor pronóstico son: mayor edad, valoración mediante la escala CURB‑65, el nivel de requerimiento de soporte respiratorio, neumonía grave (CURB‑65), hipertransaminasemia, elevación de creatina-quinasa, lactato- deshidrogenasa, y dímero-D, anemia y elevación de la frecuencia respiratoria.

4.
Farmacia Hospitalaria ; : 15, 2022.
Article in Spanish | Web of Science | ID: covidwho-1761113

ABSTRACT

Objective: To determine the baseline characteristics associated with higher mortality at 42 days in patients hospitalized for COVID-19 in Spain. Method: The study analyzed a prospective cohort of hospitalized COVID-19 patients. The dependent variable was 42-day mortality. Data on the subjects' demographic and clinical characteristics, comorbidities, usual therapy and supportive interventions and treatments was collected within 48 hours from admission. To determine the potential association of the data with mortality, a multivariate analysis was performed using logistic regression. Results: 15,628 patients were included, 18.2% of whom (n = 2,806) died during the study period. According to the multivariate analysis, the variables that were significantly associated (p < 0.05) with mortality upon admission were: being referred from a nursing home (OR 1.9);having a high respiratory rate (OR 1,5);having moderate (OR 1.7) or severe (OR 2.9) pneumonia (CURB-65);aspartate aminotransferase transami- nase >= 100 IU/l (OR 2.1);lactate dehydrogenase >= 360 IU/L (OR 1.6);procalcitonin > 0.5 ng/mL (OR 1.8);creatine kinase >= 294 U/L (OR 1.5);D-dimer > 3,000 ng/mL (OR 1.5);hemoglobin < 11.6 g/dL (OR 1.4) and C-reactive protein > 120 mg/L (OR 1.2;requiring respiratory support within the first 48 hours (oxygen therapy [OR 2.0], non-invasive ventilation [OR 2.8], and mechanical ventilation [OR 3.5]);and being treated with interferon-beta (OR 1.5). On the contrary, being under 80 years of age was associated with lower mortality. Conclusions: The analysis, based on the data in the RERFAR registry, showed that the factors associated with poorer prognosis were older age, assessed using the CURB-65 scale, level of respiratory support required, severe pneu-monia (CURB-65), hypertransaminasemia, elevated creatine kinase, lactate and D-dimer levels, anemia, and elevated rate.

5.
Rev Esp Quimioter ; 35(3): 249-259, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1744333

ABSTRACT

OBJECTIVE: A possible benefit has been suggested for early treatment of severe coronavirus disease 2019 (COVID-19) with remdesivir. The efficacy of this drug is controversial and could significantly influence the efficiency in healthcare systems. The objective is the methodological interpretation of subgroup analyzes according to starting of remdesivir treatment with respect to symptom onset of COVID-19. METHODS: A search in Pubmed® database was performed. Randomized clinical trials (RCTs) with subgroup analysis regarding early and late use of remdesivir were selected. All endpoints were assessed using two methodologies. First methodology considered statistical interaction, pre-specification, biological plausibility, and consistency of results. Second methodology was a validated tool with preliminary questions to discard subset analysis without relevant minimum conditions, and a checklist with recommendations for applicability. RESULTS: A total of 54 results were found and five RCTs were selected. According first methodology, consistent heterogeneity was only found in time to clinical improvement and better clinical status score at day 15 for patients with severe COVID-19 and <7 days of symptoms. About second methodology, these results about early use of remdesivir may be applied to clinical practice with caution. CONCLUSIONS: We developed a systematic search and application of an established methodology for interpretation of subgroup analysis about early use of remdesivir. Results in severe COVID-19 suggested that early use of remdesivir provides a greater benefit in <7 days of symptoms for time to clinical improvement and better clinical status score at day 15. Future studies could use 7-day cut-off of symptoms to evaluate remdesivir.


Subject(s)
COVID-19 , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/therapeutic use , Alanine/analogs & derivatives , Alanine/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Humans
6.
Journal of Crohn's and Colitis ; 16:i204-i206, 2022.
Article in English | EMBASE | ID: covidwho-1722306

ABSTRACT

Background: This study aimed to compare the risk of COVID-19 in patients with IBD versus the general population, and to evaluate predictors of infection acquisition, progression to severe forms, and risk of developing persistent COVID-19. We also assess the differences between cases across the different COVID-19 pandemic waves in our target population. Methods: This single-centre prospective, cohort study included consecutive IBD patients diagnosed of COVID-19 either by a positive polymerase chain reaction test and/or antigen test in nasopharyngeal swabs, or by anti-SARS-CoV-2 antibodies, and that they had a follow-up of at least 4 months. Using logistic regression, we evaluated cases versus IBD controls included in the IBD Unit database for predictors of COVID-19 acquisition. COVID-19 cases were distributed according to pandemic waves. Cox regression analysis was used for predictors of severe and persistent COVID-19. Results: By May 31, 2021, 160 out of 1911 IBD patients (8.3%) were diagnosed with COVID-19. IBD patients had a similar adjusted incidence of COVID-19 (OR 0.94;95% CI 0.86-1.02;P=0.42), and a similar associated mortality ratio (OR 0.83;95% CI 0.6-1.06;P=0.48), compared to the general population. In multivariable analysis, treatment with biologics was associated with a higher risk (OR 2.22, P<0.001), and treatment with salicylates with a lower risk (OR 0.71, P=0.048) of contracting COVID-19.(Table 1) 62 COVID-19 cases were diagnosed during the first wave of pandemic (until the end of June 2020), and 54 and 44 cases during the second and third waves (until the end of December 2020 and May 2021, respectively).(Figure 1) In multivariate analysis, first wave cases were associated with a higher risk of progression to severe forms of infection (OR 4.76, 95% CI 1.83-12.37, P=0.001), and development of persistent COVID-19 (OR 2.4, 95% CI 1.16-4.95, P=0.018). 29 patients (18.1%) required hospitalisation and were classified as severe COVID-19, which was associated in multivariable analysis with age>48 (HR 3.68, P=0.007), cases diagnosed in the first wave (HR 6.04, P<0.001), and comorbidities (evaluated with Duke Severity of Illness Checklist [DUSOI], P<0.001).(Table 2) During a median follow-up of 8.4 months, 68 patients (42.5%) were diagnosed with persistent COVID-19. Multivariable analysis identified UC (P=0.053), comorbidities (P=0.090), and being diagnosed during the first wave (P=0.011) as risk factors for persistent COVID-19.(Table 3) Conclusion: IBD patients have a similar risk of COVID-19 and associated mortality as the general population. Cases diagnosed during the first wave of the pandemic had severe and persistent forms of COVID-19 more frequently. Age and comorbidity were the main risk factors for severe forms of the disease.

7.
Radiotherapy and Oncology ; 161:S1248-S1249, 2021.
Article in English | EMBASE | ID: covidwho-1492825

ABSTRACT

Purpose or Objective: Cancer diagnostics and surgery have been disrupted by the response of health care services to the coronavirus disease pandemic. With the COVID-19 irruption in 2020, some radiotherapy treatments were omitted, delayed, changed intent or shifted to a hypofractionated scheme. The purpose of this study is to investigate the effect, direct or indirect, that COVID-19 has had on radiotherapy treatments in comparison with previous years. Materials and Methods: All treatments from 2018 (1521), 2019 (1498) and 2020 (1613) were analysed. Treatments were separated into two categories regarding treatment intent: curative or palliative. Moreover curative treatments were classified by site or pathology: H&N, lung, rectum, prostate, breast, central nervous system (CNS), gynaecological, SBRT and other sites. Percentage of hypofractionated treatments per year (for those with curative intent) was also taken into account. Results: Regarding treatment intent, we have found that the number of palliative treatments was similar to previous years: 38% in 2020, 37 % in 2018 and 35% in 2019. Figure I shows the percentage of hypofractionated treatments. During 2020 there were 10% hypofractionated treatments more than 2019, which is more than a threefold increase compared to the growth between 2018 and 2019 (3%). (Figure Presented) Conclusion: On one side, reasons related directly or indirectly with COVID-19 do not had an effect on the treatment intent in our department: similar number of palliative treatments was reported during 2020. On the other side, the use of hypofractionated schemes was accelerated during the pandemic, following national and international recommendations. This has allowed reducing treatment time bringing more comfort to the patients. To resume, it is difficult to assess whether the pandemic had a negative effect on cancer treatments based on treatment intent. Deeper analysis of cancer staging could reveal a different result related to collateral damage to the pandemic.

8.
European Journal of Hospital Pharmacy ; 28(SUPPL 1):A63, 2021.
Article in English | EMBASE | ID: covidwho-1186314

ABSTRACT

Background and importance The SARS-CoV-2 pandemic could have changed the clinical management of cancer patients because of travel restrictions, overloading of hospital systems and disruption of treatment. Lung cancer patients constitute a vulnerable population due to the particular risk of their disease, chemotherapy or immunotherapy. Aim and objectives To analyse disease management and the clinical impact of the COVID-19 pandemic on non-small cell lung cancer (NSCLC) patients receiving intravenous treatment during the social isolation period compared with the normal situation. Material and methods This retrospective observational cohort study included a 2:1 random sample of NSCLC patients in the 'COVID cohort' (patients in isolation February 2020 to June 2020) and the 'no COVID cohort' (patients treated between February 2019 and June 2019). Collected variables from digital clinical history were age, sex, stage, previous lines, type of treatment, number of medical visits and telephone consults, cycles received, worsening of performance status (PS), respiratory infection (COVID-19 and others), delays, therapeutic rest break, disease progression and deaths. Results COVID cohort (CC): 40 patients, 31 (78%) men;mean 67 years (59-84). Cancer stage: IV (69%), IIIB (28%), IIIA (2%) and IIIC (1%). 12 (30%) patients had not received lines previously. 38% of the population received immunotherapy. Median number of medical visits was 3 (14-1) and median number of telephone consults was 3 (1-8). Median number of cycles was 4 (1-16). PS 0 (58%) and PS 1 (42%). No patient had COVID-19. No COVID cohort' (NCC): 20 patients, 15 (75%) men, mean 67 years (54-85). Cancer stage: stage IV (75%), IIIB (25%). All patients had received lines previously and none had received immunotherapy. Median medical visits was 7 (3- 11) with no telephone consults. Median number of cycles was 3 (1-11). PS 0 (70%) and PS1-2 (30%). The rest of the variables are shown in table 1. Conclusion and relevance In spite of the limitations of the study, the new strategies of clinical management during the COVID-19 pandemic (telephone consults and therapeutic tire) did not appear to affect disease progression and NSCLC patient survival although worsening of performance status was observed.

9.
European Journal of Hospital Pharmacy ; 28(SUPPL 1):A7, 2021.
Article in English | EMBASE | ID: covidwho-1186297

ABSTRACT

Background and importance A greater benefit was suggested with early treatment with remdesivir against COVID-19. Aim and objectives To develop a systematic review and methodological interpretation of subgroup analyses according to timing of use of remdesivir in COVID-19. Material and methods A bibliographic review in MEDLINE was conducted up to 10 October 2020. The 'Clinical Queries/ Narrow' tool was used with the search strategy: ((Therapy/ Narrow[filter]) AND (remdesivir AND COVID)). Randomised clinical trials (RCTs) with subset analysis about early and late use of remdesivir (≤10 vs >10 days from symptom onset, or ≤9 vs >9 days) were selected. The rest of the studies were excluded. All endpoints with subgroup analysis regarding timing of remdesivir use were assessed. Two methodologies were applied. The first considered statistical interaction among subsets, prespecification, biological plausibility and consistency of the subgroup analyses of similar RCTs.1 The second methodology was a validated tool with preliminary questions to discard subset analysis without minimal relevance, and a checklist.2 This checklist assigned a score related to a recommendation for applicability of subgroup analysis in clinical practice. Results 20 results were found after review;16 studies were excluded because they were not RCTs and 1 study had no efficacy evaluation of remdesivir. Therefore, three RCTs were selected. Endpoints considered were: time to clinical improvement, mortality, viral load, and clinical status at days 11 and 15. According to the first methodology, no statistical interaction was observed in the outcomes of the RCTs. Prespecification was established in time to clinical improvement, and clinical status at day 15 of an RCT. Biological plausibility was described in the subset analysis of each endpoint of the RCTs. No consistency of subgroup analyses were found. The second methodology discarded the applicability of the subset analysis through preliminary questions in two RCTs because of the absence of minimal relevance. For the third RCT, 'null' recommendation (score -3 points) of clinical applicability was reached for clinical status at day 11. Conclusion and relevance No differences were found between early and late use of remdesivir in COVID-19. We developed the first study with a systematic review and methodology about subgroup analysis of timing of use of remdesivir.

10.
European Journal of Hospital Pharmacy. Science and Practice ; 28(Suppl 1):A63, 2021.
Article in English | ProQuest Central | ID: covidwho-1133242

ABSTRACT

4CPS-296 Table 1CC (%) NCC (%) RAR 30% (95% CI) p value Worsening PS 30 0 15.8 to 44.2 <0.05Therapeutic rest break 35 0 20.2 to 49.7 <0.05 Delays 100 30 −90.1 to −49.9 <0.05 Respiratory infections 10 15 −13.2 to 23.2 >0.05 Disease progression 30 45 −11.2 to 41.2 >0.05 Deaths 18 25 −14.8 to 29.8 >0.05 Conclusion and relevanceIn spite of the limitations of the study, the new strategies of clinical management during the COVID-19 pandemic (telephone consults and therapeutic tire) did not appear to affect disease progression and NSCLC patient survival although worsening of performance status was observed.References and/or acknowledgementsConflict of interestNo conflict of interest

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