Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe COVID-19 pneumonia and hyperinflammation: a randomized clinical trial.

Some patients with COVID-19 pneumonia develop an associated cytokine storm syndrome that aggravates the pulmonary disease. These patients may benefit of anti-inflammatory treatment. The role of colchicine in hospitalized patients with COVID-19 pneumonia and established hyperinflammation remains unexplored. In a prospective, randomized controlled, observer-blinded endpoint, investigator-initiated trial, 240 hospitalized patients with COVID-19 pneumonia and established hyperinflammation were randomly allocated to receive oral colchicine or not. The primary efficacy outcome measure was a composite of non-invasive mechanical ventilation (CPAP or BiPAP), admission to the intensive care unit, invasive mechanical ventilation requirement or death. The composite primary outcome occurred in 19.3% of the total study population. The composite primary outcome was similar in the two arms (17% in colchicine group vs. 20.8% in the control group; p = 0.533) and the same applied to each of its individual components. Most patients received steroids (98%) and heparin (99%), with similar doses in both groups. In this trial, including adult patients with COVID-19 pneumonia and associated hyperinflammation, no clinical benefit was observed with short-course colchicine treatment beyond standard care regarding the combined outcome measurement of CPAP/BiPAP use, ICU admission, invasive mechanical ventilation or death (Funded by the Community of Madrid, EudraCT Number: 2020-001841-38; 26/04/2020).

Use of glucocorticoids megadoses in SARS-CoV-2 infection in a spanish registry: SEMI-COVID-19.

OBJECTIVE: To describe the impact of different doses of corticosteroids on the evolution of patients with COVID-19 pneumonia, based on the potential benefit of the non-genomic mechanism of these drugs at higher doses. METHODS: Observational study using data collected from the SEMI-COVID-19 Registry. We evaluated the epidemiological, radiological and analytical scenario between patients treated with megadoses therapy of corticosteroids vs low-dose of corticosteroids and the development of complications. The primary endpoint was all-cause in-hospital mortality according to use of corticosteroids megadoses. RESULTS: Of a total of 14,921 patients, corticosteroids were used in 5,262 (35.3%). Of them, 2,216 (46%) specifically received megadoses. Age was a factor that differed between those who received megadoses therapy versus those who did not in a significant manner (69 years [IQR 59-79] vs 73 years [IQR 61-83]; p < .001). Radiological and analytical findings showed a higher use of megadoses therapy among patients with an interstitial infiltrate and elevated inflammatory markers associated with COVID-19. In the univariate study it appears that steroid use is associated with increased mortality (OR 2.07 95% CI 1.91-2.24 p < .001) and megadose use with increased survival (OR 0.84 95% CI 0.75-0.96, p 0.011), but when adjusting for possible confounding factors, it is observed that the use of megadoses is also associated with higher mortality (OR 1.54, 95% CI 1.32-1.80; p < .001). There is no difference between megadoses and low-dose (p .298). Although, there are differences in the use of megadoses versus low-dose in terms of complications, mainly infectious, with fewer pneumonias and sepsis in the megadoses group (OR 0.82 95% CI 0.71-0.95; p < .001 and OR 0.80 95% CI 0.65-0.97; p < .001) respectively. CONCLUSION: There is no difference in mortality with megadoses versus low-dose, but there is a lower incidence of infectious complications with glucocorticoid megadoses.

[Isolated facial diplegia as an atypical variant of Guillain-Barre syndrome after suspected SARS-CoV-2 infection] / Diplejía facial aislada como variante atípica del síndrome de Guillain-Barré tras sospecha de infección por SARS-CoV-2.

Introduction: Since the SARS-CoV-2 pandemics began, multiple cases of Guillain-Barre syndrome secondary to COVID-19 have been described. Its typical presentation consists of the triad of paresthesia, ascending muscle weakness and areflexia, although there are several regional variants such as facial diplegia. Case presentation: Two weeks after a contact with a confirmed case of COVID-19, a 35-year-old woman presents with viral myopericarditis. Laboratory studies for autoimmune diseases come back negative, as well as multiple viral serologies. She presents anti-SARS-CoV-2 IgG, with negative PCR. A week after discharge she presents with palsy of both facial nerves, without other neurological abnormalities. She undergoes examination with cranial CT without findings, and an EMG which shows bilateral alteration of facial nerves. She refuses the performance of a lumbar puncture. Discussion: Facial diplegia can occur because of several illnesses, such as meningeal or brainstem tumors, infectious agents, Guillain-Barre syndrome, autoimmune diseases, trauma, metabolic causes or congenital causes. In our patient, having discarded other etiologies with imaging and analytical studies, the most probable cause is the Guillain-Barre syndrome. It is possibly secondary to SARS-CoV-2 infection given the presence of anti-SARS-CoV-2 IgG antibodies after contact with a confirmed case. Conclusion: This case supports the hypothesis that COVID-19 may trigger the Guillain-Barre syndrome, specifically as facial diplegia, which is an atypical variant that should be known to be early diagnosed and treated as part of this syndrome.

Introducción: Desde que se inició la pandemia por el SARS-CoV-2, se han descrito numerosos casos de síndrome de Guillain-Barré secundario a la COVID-19. Su presentación típica es la triada de parestesias, debilidad muscular ascendente y arreflexia, aunque hay diversas variantes regionales como la diplejía facial. Presentación del caso: Mujer de 35 años que, dos semanas después de un contacto estrecho con un caso confirmado de COVID-19, ingresa por miopericarditis probablemente viral, con estudio de autoinmunidad negativo, múltiples serologías virales negativas y positividad para IgG anti-SARS-CoV-2 con PCR negativa. Una semana tras el alta presenta paresia de ambos nervios faciales sin otras alteraciones neurológicas. Se realiza TAC craneal sin hallazgos y EMG que evidencia afectación bilateral de los nervios faciales. La paciente rechaza realización de punción lumbar Discusión: La diplejía facial puede ocurrir en el contexto de diversas patologías, como tumores meníngeos o troncoencefálicos, agentes infecciosos, síndrome de Guillain-Barré, patologías autoinmunes, traumatismos, causas metabólicas o causas congénitas. En el caso descrito tras descartar mediante pruebas de imagen y analíticamente el resto de etiologías, y dada la presentación clínica, permanece como causa más probable el síndrome de Guillain-Barré, posiblemente secundario a infección por SARS-CoV-2 dada la positividad de IgG anti-SARS-CoV-2 tras un contacto con un caso confirmado. Conclusión: Este caso apoya la hipótesis de que la COVID-19 puede desencadenar el síndrome de Guillain-Barré, específicamente en forma de diplejía facial, una variante atípica que se debe conocer para su identificación y manejo precoz como parte de este síndrome.

Real-Life Impact of Glucocorticoid Treatment in COVID-19 Mortality: A Multicenter Retrospective Study.

We aimed to determine the impact of steroid use in COVID-19 in-hospital mortality, in a retrospective cohort study of the SEMICOVID19 database of admitted patients with SARS-CoV-2 laboratory-confirmed pneumonia from 131 Spanish hospitals. Patients treated with corticosteroids were compared to patients not treated with corticosteroids; and adjusted using a propensity-score for steroid treatment. From March-July 2020, 5.262 (35.26%) were treated with corticosteroids and 9.659 (64.73%) were not. In-hospital mortality overall was 20.50%; it was higher in patients treated with corticosteroids than in controls (28.5% versus 16.2%, OR 2.068 [95% confidence interval; 1.908 to 2.242]; p = 0.0001); however, when adjusting by occurrence of ARDS, mortality was significantly lower in the steroid group (43.4% versus 57.6%; OR 0.564 [95% confidence interval; 0.503 to 0.633]; p = 0.0001). Moreover, the greater the respiratory failure, the greater the impact on mortality of the steroid treatment. When adjusting these results including the propensity score as a covariate, in-hospital mortality remained significantly lower in the steroid group (OR 0.774 [0.660 to 0.907], p = 0.002). Steroid treatment reduced mortality by 24% relative to no steroid treatment (RRR 0.24). These results support the use of glucocorticoids in COVID-19 in this subgroup of patients.

Tacrolimus in non-Asian patients with SLE: a real-life experience from three European centres.

OBJECTIVES: To analyse the real-life practice on the use of Tacrolimus (TAC) in patients with systemic lupus erythematosus (SLE) from three European SLE referral centres. METHODS: Adult patients with SLE regularly followed at three European referral centres were included. Demographics, cumulative organ involvement, treatment history, Systemic Lupus Disease Activity Index (SLEDAI), laboratory features and physician's judgement were collected at baseline and at 3-6-12 months after starting TAC. RESULTS: 29 patients were included (89% female, mean age 38±9 years). Ethnicity was predominantly Caucasian (82%), Black African (11%), Hispanic (3.5%) and Caribbean (3.5%). The main indications for TAC prescription were renal involvement (82.7%), arthritis (10.3%), cutaneous manifestations (6.8%), haematological manifestations (6.8%), serositis (3.4%). At 3 months, there was a clinical improvement in 21 patients (72.4%) and 9 of these experienced a complete resolution of symptoms (31%). This corresponds to: (1) a significant decrease in the mean SLEDAI; (2) a significant decrease in the mean 24 hours proteinuria; a significant increase in C3 and stable creatinine values. At 6 months (n=25), the physician declared an improvement in 19 patients (76%) and a complete resolution of symptoms in 9 (36%). The same trend was observed at 12 months of follow-up. TAC was discontinued in nine pts (31%); reasons for discontinuation were inefficacy (13.8%), drug intolerance (10%) and disease remission (6.9%). CONCLUSIONS: Despite the limitation due to the small number of patients and the uncontrolled nature of the study, these data show that TAC can be considered a valid therapeutic option in patients with SLE, especially for renal involvement.