Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial—Protocol and statistical analysis plan

Introduction

Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.

Methods

The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.

Discussion

The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.

     

Disability,depression and somatization in a low back pain population

Objective: The aim of this study was to determine the prevalence of low back pain (LBP) in a primary care setting population and examine its association with the symptoms of depression and somatization. Methods: This is a cross‐sectional study, utilising a survey carried out in primary health care clinics (PHCs) in Al‐Ain, United Arab Emirates (UAE). A multistage stratified sampling design was used and a representative sample of 1304 UAE nationals aged 18–65 years who attended PHC clinics for any reason were included and 1103 (84.5%) subjects agreed to participate and responded to the questionnaire during a period from June 2001 to January 2002. A specially designed questionnaire with three parts was used for the data collection: socio‐demographic information of the studied subjects, modified version of the Roland‐Morris scale for evaluating back‐related functional disability and SCL‐90 R for depression and somatization subscales was used to assess depressive and somatic symptoms. Results: Of the total number of subjects surveyed (1103), 586 (53.1%) were men and 517 (46.9%) women. The mean age was 34.9 ± 13.4 years for men and 33.5 ± 11.8 years for women. The prevalence of LBP in the studied subjects was 64.7% (95% CI, 60.7–68.5] with 46.7% among men and 53.3% among women. There were a significant differences between the subjects with LBP and without LBP with respect to gender (P < 0.001), body mass index (BMI) (P < 0.001), occupational status (P < 0.001) and living environment (P = 0.016). Functional disability was higher in patients with LBP. Young patients in aged 15–34 years, patients with preparatory/secondary educational level and students showed higher depressive symptoms. A similar pattern was found in patients with somatic symptoms. Factor analysis revealed a strong association between depression and somatization in LBP patients. Conclusions: Functional disability was higher in with LBP. Furthermore, symptoms of depression and somatization are prevalent among LBP patients.     

A combined course of primary health care practice and family medicine at the University of Gezira

The community-based course presented is a longitudinal course running through four semesters in the Faculty of Medicine, University of Gezira, Sudan. Students combine their regular work in primary health care centres with attachments to a number of families in Wad Medani town. They continue to visit these families regularly throughout their entire medical course with the aim of studying them and helping them with some of their medical and psychosocial problems.     

Correlation between the intensity of cytomegalovirus infection and the amount of perivasculitis in aortic allografts

Abstract  We previously demonstrated that cytomegalovirus (CMV) infection enhanced perivascular inflammation in rat aortic allografts. In this study, we investigated the relationship between the CMV infection load and the magnitude of perivasculitis (chronic rejection) in aortic transplants. Rats received or-thotopic abdominal aortic grafts, different degrees of total body irradiation (TBI) for immunosuppres-sion and CMV inoculation. The spleens of the rats receiving 5 Gy of TBI contained more infectious virus and viral antigens than those of rats receiving 3 Gy of TBI or no TBI. Although the number of inflammatory cells infiltrating the perivascular area was decreased after TBI, CMV infection resulted in increased perivasculitis in rats that received 5 Gy of TBI as compared to non-infected animals. This virus-induced effect was characterized predominantly by an increased T-cell infiltration, including CD4 and CD8 T-cells. It is concluded that an enhanced systemic CMV infection during severe immunosuppressive therapy can accelerate the development of chronic rejection, which seems to be mediated mainly by T-cells.     

Long‐standing ulcerative colitis complicated by right subclavian artery occlusion and upper limbs arteriolitis with digital ischemia

A 48‐year‐old male patient with long‐standing ulcerative colitis since February 2001 which was diagnosed by endoscopy, developed acute digital ischemia affecting both hands with fixed colour changes in the left index finger which was followed shortly by digital ulceration. Magnetic resonance angiography (MRA) of both upper limbs showed evidence of vasculitis affecting digital arterioles on both sided and right subclavian occlusion. The patient received pulse methylprednisolone followed by cyclophosphamide pulse therapy, the latter continuing on a monthly basis for 6 months with appreciable improvement and remission of the vasculitic process; follow‐up MRA showed reperfusion of the previously occluded subcalvian artery. To the authors’ knowledge vasculitis complicating the course of ulcerative colitis is a rare association and is only sporadically reported in the literature. This rare entity should be diagnosed early and aggressively treated; MRA is a very promising diagnostic tool that is suitable for both diagnosis and follow‐up of patients with this rare entity.