ABSTRACT
BackgroundCytokine release syndrome (CRS) or cytokine storm is thought to be the cause of inflammatory lung damage, worsening pneumonia and death in patients with COVID-19. Steroids (Methylprednisolone or Dexamethasone) and Tocilizumab (TCZ), an interleukin-6 receptor antagonist, are approved for the treatment of CRS in India. The aim of this study was to evaluate the efficacy and safety of combination therapy of TCZ and steroids in COVID-19 associated CRS. MethodsThis retrospective cohort study was conducted at a tertiary level private hospital in Pune, India between 2nd April and 2nd November 2020. All patients administered TCZ and steroids for treatment of CRS were included. The primary endpoint was incidence of all-cause mortality. Secondary outcomes studied were need for mechanical ventilation and incidence of infectious complications. Baseline and time-dependent risk factors significantly associated with death were identified by Relative risk estimation. ResultsOut of 2831 admitted patients, 515 (24.3% females) were administered TCZ and steroids. Median age of the cohort was 57 (IQR: 46.5, 66) years. Almost 72 % patients had preexisting co-morbidities. Median time to TCZ administration since onset of symptoms was 9 days (IQR: 7, 11). 63% patients needed intensive care unit (ICU) admission. Mechanical ventilation was required in 242 (47%) patients. Of these, 44.2% (107/242) recovered and were weaned off the ventilator. There were 135 deaths (26.2%), while 380 patients (73.8%) had clinical improvement. Infectious complications like hospital acquired pneumonia, bloodstream bacterial and fungal infections were observed in 2.13 %, 2.13 % and 0.06 % patients respectively. Age [≥] 60 years (p=0.014), presence of co-morbidities like hypertension (p = 0.011), IL-6 [≥] 100 pg/ml (p = 0.002), D-dimer [≥] 1000 ng/ml (p < 0.0001), CT severity index [≥] 18 (p < 0.0001) and systemic complications like lung fibrosis (p = 0.019), cardiac arrhythmia (p < 0.0001), hypotension (p < 0.0001) and encephalopathy (p < 0.0001) were associated with increased risk of death. ConclusionsCombination therapy of TCZ and Steroids is likely to be safe and effective in the management of COVID-19 associated cytokine release syndrome. Efficacy of this anti-inflammatory combination therapy needs to be validated in randomized controlled clinical trials.
ABSTRACT
IntroductionThe shortage of personal protective equipment (PPE) across the country has been widely discussed throughout the COVID-19 pandemic. Unfortunately, recent reports indicate that PPE shortages persist amidst continually increasing caseloads nationwide. Additionally, there have been reports of poor-fitting masks, a problem which is magnified by shortages. The lack of adequate access to conventional N95 masks pushed for some to pursue 3D printing and locally distributing their own manufactured masks as substitutes when PPE, including N95 masks, were not readily available. The design presented, the snorkel mask adapter, is one such design born from the local maker community in partnership with local physicians and hospitals. This article discusses the design, manufacturing, and validation of the snorkel mask adapter and its immediate use in the COVID-19 pandemic as well as future use as stopgap PPE. MethodsThe design presented is an adapter which can be used with a commercially available snorkel mask in order to serve as a full face respirator in either the case of a PPE shortage or more pertinently for those who are unable to pass fit testing with the available N95 respirators at their respective facilities. Mask components were 3D printed, assembled, and then fit tested by qualitative fit testing (QLFT) at The University of Kansas Health System (TUKHS) in Kansas City, KS as a proof of concept. ResultsAt TUKHS, the mask was fit tested on 22 individuals who required an N95 mask but were not able to pass qualitative fit testing with the masks available to them at the time. Of the 22 tested, all 22 of them were able to pass QLFT with the snorkel mask, adapter, and viral/bacterial filter combination. ConclusionThe results of the fit testing at TUKHS is promising for this N95 alternative. More extensive testing can and should be done, including quantitative fit testing. Persistently increasing caseloads and PPE shortages necessitates an urgent dissemination of these preliminary results. The authors do not advocate for this design as a replacement of traditional N95 masks or other PPE but do endorse this design as a stopgap measure, proven to be effective in situations of dire PPE shortage or for individuals who have failed fit testing with conventional PPE.
