Characteristics and clinical outcome in 312 patients with moderate to severe pneumonia due to SARS-COV-2 and hyperinflammation treated with anakinra and corticosteroids: A retrospective cohort study.

OBJECTIVE: To assess the clinical outcome (death and/or Intensive Care Unit (ICU) admission) based on the time from hospital admission to the administration of anakinra and the possible usefulness of a "simplified" SCOPE score to stratify the risk of worse prognosis in our cohort of patients with moderate/severe SARS-CoV-2 pneumonia, both vaccinated and unvaccinated, that received anakinra and corticosteroids. In addition, the clinical, analytical, and imaging characteristics of patients at admission are described. METHODS: Retrospective cohort study of 312 patients admitted to Hospital Clínico San Cecilio in Granada for moderate/severe pneumonia caused by SARS-CoV-2 that received anakinra and corticosteroids between March 2020 and January 2022. Clinical and analytical data were collected as well as the patient outcome at 30 and 60 days after admission. Three treatment groups were established according to the time from hospital admission to administration of anakinra: early (1st-2nd day), intermediate (3rd-5th day), and late (after the 5th day). RESULTS: The median age was 67.4 years (IQR 22-97 years) and 204 (65.4%) were male. The most common comorbidity was hypertension (58%). The median time from the start of symptoms to anakinra administration was 6 days (IQR 5-10) and the SaFi (SaO2/FiO2) was 228 (IQR 71-471). The cure rate was higher in the early-onset anakinra group versus the late-onset group (73% vs 56.6%). The latter had a higher percentage of deaths (27.4%) and a greater number of patients remained hospitalized for a month (16%). On admission, the patients had elevated C-reactive protein (CRP), ferritin, and D-dimer values and decreased total lymphocytes. Analytical improvement was observed at both 72 hours and one month after treatment. 42 (13.5%) required ICU admission, and 23 (7.3%) orotracheal intubation. At 60 days, 221 (70.8%) were discharged, 87 (27.8%) had died and 4 (1.4%) remained hospitalized. The mean dose of anakinra was 1000 mg (100-2600 mg) with differences found between the dose administered and the clinical outcome. There were no differences in the primary outcome based on vaccination. A simplified SCOPE score at the start of anakinra administration was lower in patients with better clinical evolution. CONCLUSIONS: Early treatment with anakinra and corticosteroids was associated with a better outcome regardless of vaccination status. A simplified SCOPE was found to be a good prognostic tool.

Dexamethasone versus weight-adjusted methylprednisolone in patients with moderate-severe SARS-CoV-2 pneumonia. / Dexametasona frente a metilprednisolona ajustada al peso en pacientes con neumonía moderada-grave por SARS-CoV-2.

OBJECTIVES: To compare the 30-day outcome (mortality and/or ICU admission) of patients admitted for moderate-severe SARS-CoV-2 pneumonia treated with dexamethasone after the Recovery study versus those treated with weight-adjusted methylprednisolone. METHODS: Retrospective cohort study of 65 patients with moderate-severe pneumonia who received dexamethasone 6 mg/day (DXM group) versus 80 treated with weight-adjusted methylprednisolone (MTPN group). RESULTS: Twenty-one (32.3%) patients in the DXM group died vs. 8 (10%) in the MTPN group (p-value < 0.001) and 29 (44.6%) in the DXM group required ICU admission vs. 2 (2.5%) of the MTPN group (p-value < 0.001). There were no baseline differences regarding sociodemographic characteristics with a higher mean qSOFA in the MTPN group. The hazard ratio for mortality and ICU admission adjusted for age, sex, and admission CRP was 2.189 (1.082-4.426; 95% CI) and 10.589 (2.139-48.347; 95% CI) for the DXM group, respectively, vs. MTPN group. CONCLUSIONS: Mortality and admission to the ICU were lower in patients treated with weight-adjusted methylprednisolone compared to those treated with dexamethasone.

Dexamethasone versus weight-adjusted methylprednisolone in patients with moderate-severe SARS-CoV-2 pneumonia Dexametasona frente a metilprednisolona ajustada al peso en pacientes con Neumonía moderada-grave por SARS-CoV-2

Objectives To compare the 30-day outcome (mortality and/or ICU admission) of patients admitted for moderate-severe SARS-CoV-2 pneumonia treated with dexamethasone after the Recovery study versus those treated with weight-adjusted methylprednisolone. Methods Retrospective cohort study of 65 patients with moderate-severe pneumonia who received dexamethasone 6 mg/day (DXM group) versus 80 treated with weight-adjusted methylprednisolone (MTPN group) Results 21 (32.3%) patients in the DXM group died vs 8 (10%) in the MTPN group (p-value < 0.001) and 29 (44.6%) in the DXM group required ICU admission vs 2 (2,5%) of the MTPN group (p-value <0.001). There were no baseline differences regarding sociodemographic characteristics with a higher mean qSOFA in the MTPN group. The hazard ratio for mortality and ICU admission adjusted for age, sex, and admission CRP was 2.189 (1.082-4.426;95% CI) and 10.589 (2.139-48.347;95% CI) for the DXM group, respectively., vs MTPN group. Conclusions Mortality and admission to the ICU were lower in patients treated with weight-adjusted methylprednisolone compared to those treated with dexamethasone.

Dexamethasone versus weight-adjusted methylprednisolone in patients with moderate-severe SARS-CoV-2 pneumonia.

Objectives: To compare the 30-day outcome (mortality and/or ICU admission) of patients admitted for moderate-severe SARS-CoV-2 pneumonia treated with dexamethasone after the Recovery study versus those treated with weight-adjusted methylprednisolone. Methods: Retrospective cohort study of 65 patients with moderate-severe pneumonia who received dexamethasone 6 mg/day (DXM group) versus 80 treated with weight-adjusted methylprednisolone (MTPN group). Results: 21 (32.3%) patients in the DXM group died vs 8 (10%) in the MTPN group (p-value < 0.001) and 29 (44.6%) in the DXM group required ICU admission vs 2 (2,5%) of the MTPN group (p-value <0.001). There were no baseline differences regarding sociodemographic characteristics with a higher mean qSOFA in the MTPN group. The hazard ratio for mortality and ICU admission adjusted for age, sex, and admission CRP was 2.189 (1.082-4.426; 95% CI) and 10.589 (2.139-48.347; 95% CI) for the DXM group, respectively, vs. MTPN group. Conclusions: Mortality and admission to the ICU were lower in patients treated with weight-adjusted methylprednisolone compared to those treated with dexamethasone.

Objetivos: Comparar el desenlace clínico (mortalidad y/o ingreso en UCI) a 30 días de los pacientes ingresados por neumonía moderada-grave por SARS-CoV-2 tratados con dexametasona tras el estudio Recovery frente aquellos tratados con metilprednisolona ajustada al peso. Métodos: Estudio de cohortes retrospectivo de 65 pacientes con neumonía moderada-grave que recibieron 6 mg/día de dexametasona (grupo DXM) frente a 80 tratados con metilprednisolona ajustada al peso (grupo MTPN). Resultados: Fallecieron 21 (32,3%) pacientes del grupo DXM vs 8 (10%) del grupo MTPN (p-valor < 0,001) y 29 (44,6%) del grupo DXM requirieron ingreso en UCI vs 2 (2,5%) del grupo MTPN (p-valor < 0,001). No hubo diferencias basales respecto a características sociodemográficas con un qSOFA medio superior en el grupo MTPN. La razón de riesgo para la mortalidad y el ingreso en UCI ajustada por edad, sexo y PCR al ingreso fue de 2,189 (1,082−4,426; IC 95%) y 10,589 (2,139−48,347; IC 95%) para el grupo DXM, respectivamente, vs grupo MTPN. Conclusiones: La mortalidad e ingreso en UCI fue menor en pacientes tratados con metilprednisolona ajustada al peso frente a los tratados con dexametasona.

Psychological Impact and Risk of Suicide in Hospitalized COVID-19 Patients, During the Initial Stage of the Pandemic: A Cross-Sectional Study.

OBJECTIVES: This study aimed to assess the psychological impact and risk of suicide in patients hospitalized for COVID-19. METHODS: A cross-sectional study was conducted on a representative sample of patients hospitalized for COVID-19 at the "San Cecilio" University Hospital (Granada, Spain) between March and May 2020. Sociodemographic and clinical variables were collected. All participants were evaluated using the Gijon's Social-Familial Evaluation Scale to assess social problems, the Impact of Event Scale-6 and the Hospital Anxiety-Depression Scale to assess psychological impact, the Columbia Suicide Severity and Beck Hopelessness scales to assess risk of suicide, and the List of Threatening Experiences questionnaire to control for confounding bias. RESULTS: Thirty-six COVID-19 patients were evaluated. Of them, 33.3% had a significant psychological impact; 13.9% showed symptoms of anxiety, 13.9% showed symptoms of depression, and 47.2% showed symptoms of anxiety-depression. Moderate and severe risk of suicide were found in 75% and 2.8% of the patients, respectively. Suicidal ideation was observed in 16.7% and suicide behaviors in 5.6% of the patients. Psychological impact was associated with previous psychological treatment, a greater degree of functional dependency, and increased social-familial risk. In addition, the risk of suicide was mainly associated with active treatment of a psychiatric illness and active smoking. No significant correlation was found between psychological impact and risk of suicide. CONCLUSIONS: Psychological impact and risk of suicide were significant in patients admitted for COVID-19. Although the risk of suicide was not associated with increased psychological impact, both should be assessed, especially in patients at higher risk based on significantly associated factors.

Glucocorticoids alone versus tocilizumab alone or glucocorticoids plus tocilizumab in patients with severe SARS-CoV-2 pneumonia and mild inflammation.

AIM: To assess clinical outcomes according to the immunosuppressive treatment administered to patients with severe SARS-CoV-2 pneumonia and moderate inflammation. METHODS: A retrospective observational cohort study involving 142 patients with severe COVID-19 pneumonia and moderate inflammation divided into three treatment groups (pulses of methylprednisolone alone [group I], tocilizumab alone [group II] and methylprednisolone plus tocilizumab [group III]). The aim was to assess intergroups differences in the clinical course with a 60-day follow-up and related analytical factors. RESULTS: 14 patients (9,8%) died: 8 (10%) in group I and 6 (9,5%) in groups II and III. 15 (10,6%) were admitted to ICU: 2 (2,5%) from group I, 4 (28,5%) from group II and 9 (18,4%) from group III. The mean hospital stay was longer in group II and clinical outcome was not associated with treatment. CONCLUSIONS: Tocilizumab seems to be not associated with better clinical outcomes and should be reserved for clinical trial scenario, since its widespread use may result in higher rate of ICU admission and longer mean hospital stay without differences in mortality rate and potentially adverse events.

OBJETIVOS: Analizar si existen diferencias en desenlaces clínicos según el tratamiento inmunosupresor recibido en pacientes con neumonía grave por SARS-CoV-2 e inflamación moderada. MÉTODOS: Estudio de cohortes retrospectivo de 142 pacientes con neumonía grave COVID-19 e inflamación moderada. Se dividieron en tres grupos de tratamiento (pulsos de metilprednisolona solo [grupo I], tocilizumab solo [grupo II] y metilprednisolona más tocilizumab [grupo III]). Analizamos las diferencias intergrupos en el curso clínico con un seguimiento de 60 días y factores clínicos analíticos relacionados. RESULTADOS: Fallecieron 14 pacientes (9,8%): 8 (10%) del grupo I y 6 (9,5%) de los grupos II y III. Quince (10,6%) ingresaron en UCI: 2 (2,5%) del grupo I, 4 (28,5%) del grupo II y 9 (18,4%) del grupo III. La estancia media hospitalaria fue mayor en los del grupo II. La evolución clínica no se asoció al tratamiento administrado. CONCLUSIONES: El uso de tocilizumab debería reservarse para escenarios de ensayos clínicos. Su utilización generalizada podría acompañarse de mayor estancia media hospitalaria e ingreso en UCI sin diferencias en la mortalidad con un potencial aumento de efectos adversos.

[Glucocorticoids alone versus tocilizumab alone or glucocorticoids plus tocilizumab in patients with severe SARS-CoV-2 pneumonia and mild inflammation]. / Glucocorticoides solos versus tocilizumab solo o glucocorticoides más tocilizumab en pacientes con neumonía grave por SARS-CoV-2 e inflamación moderada.

AIM: To assess clinical outcomes according to the immunosuppressive treatment administered to patients with severe SARS-CoV-2 pneumonia and moderate inflammation. METHODS: A retrospective observational cohort study involving 142 patients with severe COVID-19 pneumonia and moderate inflammation divided into three treatment groups (pulses of methylprednisolone alone [groupI], tocilizumab alone [groupII] and methylprednisolone plus tocilizumab [groupIII]). The aim was to assess intergroups differences in the clinical course with a 60-day follow-up and related analytical factors. RESULTS: 14 patients (9,8%) died: 8 (10%) in groupI and 6 (9,5%) in groupsII andIII. 15 (10,6%) were admitted to ICU: 2 (2,5%) from groupI, 4 (28,5%) from groupII and 9 (18,4%) from groupIII. The mean hospital stay was longer in groupII and clinical outcome was not associated with treatment. CONCLUSIONS: Tocilizumab seems to be not associated with better clinical outcomes and should be reserved for clinical trial scenario, since its widespread use may result in higher rate of ICU admission and longer mean hospital stay without differences in mortality rate and potentially adverse events.

Anakinra after treatment with corticosteroids alone or with tocilizumab in patients with severe COVID-19 pneumonia and moderate hyperinflammation. A retrospective cohort study.

INTRODUCTION: Little evidence appears to exist for the use of anakinra, a recombinant interleukin-1 receptor antagonist, after non-response to treatment with corticosteroids alone or combined with tocilizumab in patients with severe COVID-19 pneumonia and moderate hyperinflammatory state. PATIENTS AND METHODS: A retrospective observational cohort study was carried out involving 143 patients with severe COVID-19 pneumonia and moderate hyperinflammation. They received standard therapy along with pulses of methylprednisolone (group 1) or methylprednisolone plus tocilizumab (group 2), with the possibility of receiving anakinra (group 3) according to protocol. The aim of this study was to assess the role of anakinra in the clinical course (death, admission to the intensive care ward) during the first 60 days after the first corticosteroid pulse. Clinical, laboratory, and imaging characteristics as well as infectious complications were also analyzed. RESULTS: 74 patients (51.7%) in group 1, 59 (41.3%) patients in group 2, and 10 patients (7%) in group 3 were included. 8 patients (10.8%) in group 1 died, 6 (10.2%) in group 2, and 0 (0%) in group 3. After adjustment for age and clinical severity indices, treatment with anakinra was associated with a reduced risk of mortality (adjusted hazard ratio 0.518, 95% CI 0.265-0.910; p = 0.0437). Patients in group 3 had a lower mean CD4 count after 3 days of treatment. No patients in this group presented infectious complications. CONCLUSIONS: In patients with moderate hyperinflammatory state associated with severe COVID-19 pneumonia, treatment with anakinra after non-response to corticosteroids or corticosteroids plus tocilizumab therapy may be an option for the management of these patients and may improve their prognosis.