Methylprednisolone as Adjunctive Therapy for Patients Hospitalized With Coronavirus Disease 2019 (COVID-19; Metcovid): A Randomized, Double-blind, Phase IIb, Placebo-controlled Trial.

BACKGROUND: Steroid use for coronavirus disease 2019 (COVID-19) is based on the possible role of these drugs in mitigating the inflammatory response, mainly in the lungs, triggered by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study aimed to evaluate the efficacy of methylprednisolone (MP) among hospitalized patients with suspected COVID-19. METHODS: A parallel, double-blind, placebo-controlled, randomized, Phase IIb clinical trial was performed with hospitalized patients aged ≥18 years with clinical, epidemiological, and/or radiological suspected COVID-19 at a tertiary care facility in Manaus, Brazil. Patients were randomly allocated (1:1 ratio) to receive either intravenous MP (0.5 mg/kg) or placebo (saline solution) twice daily for 5 days. A modified intention-to-treat (mITT) analysis was conducted. The primary outcome was 28-day mortality. RESULTS: From 18 April to 16 June 2020, 647 patients were screened, 416 were randomized, and 393 were analyzed as mITT, with 194 individuals assigned to MP and 199 to placebo. SARS-CoV-2 infection was confirmed by reverse transcriptase polymerase chain reaction in 81.3%. The mortality rates at Day 28 were not different between groups. A subgroup analysis showed that patients over 60 years old in the MP group had a lower mortality rate at Day 28. Patients in the MP arm tended to need more insulin therapy, and no difference was seen in virus clearance in respiratory secretion until Day 7. CONCLUSIONS: The findings of this study suggest that a short course of MP in hospitalized patients with COVID-19 did not reduce mortality in the overall population. CLINICAL TRIALS REGISTRATION: NCT04343729.

Guillain-Barré Syndrome Associated with SARS-CoV-2 Infection in a Pediatric Patient.

We report the case of a 15-year-old male patient presenting frontal headaches with retro-orbital pain accompanied by fever evolving to weakness and pain of the lower limbs, which ascended to upper limbs. A COVID-19 rapid test (IgG and IgM) and nasopharyngeal swab polymerase chain reaction (PCR) was positive for SARS-CoV-2. The blood tests, cerebral spinal fluid (CSF) analysis and CSF aerobic culture revealed no abnormalities. PCR testing of the CSF was negative for the most prevalent etiologies as well as for SARS-CoV-2. Electroneurography study was compatible with the acute motor axonal neuropathy variant of Guillain-Barré syndrome. No cases involving young patients have been presented to date. Therefore, this is the first reported pediatric case of SARS-CoV-2 infection associated with GBS. Evidence reveals that SARS-CoV-2 infection is not limited to the respiratory tract. Neurotropism could explain this important neurologic manifestation of COVID-19 in children.

We report the case of a 15-year-old male patient presenting frontal headaches with retro-orbital pain accompanied by fever evolving to weakness and pain of the lower limbs, which ascended to upper limbs. A COVID-19 rapid test and nasopharyngeal molecular test were positive for the SARS-CoV-2 virus. Neurological examination attested Guillain­Barré syndrome, a condition in which the immune system attacks the nerves and could be triggered by a bacterial or viral infection. The blood tests were normal and cerebral spinal fluid analysis was negative for the most common viruses related to GBS as well as for SARS-CoV-2. Although described in adults, no cases involving young patients have been presented to date. Therefore, this is the first reported case of GBS associated with SARS-CoV-2 in children.

Chronic HDV/HBV co-infection: predictors of disease stage---a case series of HDV-3 patients.

BACKGROUND & AIMS: Chronic HDV/HBV co-infection is perhaps the most intriguing amongst all viral hepatitis. Only few studies focus deeply on this topic, particularly with patients infected with HDV-3. This study aimed to identify predictors of advanced disease, examining a cross-sectional data of 64 patients. METHODS: Histological grading was used to characterize the disease stages and viral loads were tested as predictors of necroinflammatory activity and fibrosis. RESULTS: We identified three HDV/HBV co-infection patterns: patients with predominant HDV replication (56.3%), patients with similar viral loads of both viruses (40.6%), and patients with predominant HBV replication (3.1%). Mean HDV-RNA showed a positive trend regarding inflammatory activity and grade of fibrosis. HDV viral load correlated positively with serum levels of liver enzymes and inversely with platelets count. HBV viral load showed no correlation with any of the above parameters. Advanced fibrosis was associated with age, splenomegaly, and HDV viral load of more than 2 log10. Multiple logistic regression confirmed the independent effect of HDV viral predominance. Advanced necroinflammatory activity was independently associated with HDV viral load and splenomegaly. CONCLUSIONS: HDV may possibly play an important and direct role in the establishment of necroinflammatory activity and fibrosis. Data show an indigenous HDV genotype, HDV-3, similar to those described in the Amazon region.