The awake prone position (AP) strategy for patients with acute respiratory distress syndrome (ARDS) is a safe, simple, and cost-effective technique used to improve hypoxemia. We aimed to evaluate intubation and mortality risk in patients with coronavirus disease (COVID-19) who underwent AP during hospitalisation.In this retrospective, multicentre observational study conducted between May 1 and June 12, 2020 in 27 hospitals in Mexico and Ecuador, non-intubated patients with COVID-19 managed with AP or supine positioning were included to evaluate intubation and mortality risk through logistic regression models; multivariable and centre adjustment, propensity score analyses, and E-values were calculated to limit confounding. This study was registered at https://clinicaltrials.gov/ct2/show/NCT04407468827 non-intubated patients with COVID-19 in the AP (n=505) and supine (n=322) groups were included for analysis. Less patients in the AP group required endotracheal intubation (23.6% versus 40.4%) or died (20% versus 37.9%). AP was a protective factor for intubation even after multivariable adjustment (OR=0.39, 95%CI: 0.28–0.56, p<0.0001, E-value=2.01), which prevailed after propensity score analysis (OR=0.32, 95%CI: 0.21–0.49, p<0.0001, E-value=2.21), and mortality (adjusted OR=0.38, 95%CI: 0.25–0.57, p<0.0001, E-value=1.98). The main variables associated with intubation amongst AP patients were increasing age, lower baseline SpO2/FiO2, and management with a non-rebreather mask.AP in hospitalised non-intubated patients with COVID-19 is associated with a lower risk of intubation and mortality.

BackgroundThe oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency.Methods/designThe proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited.Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3–8,and 1 mg/month in weeks 9–52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses.DiscussionThe results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment.Trial registrationThis trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Since the beginning of the pandemic, there is currently no specific treatment, however some drugs, after systematic reviews and meta-analysis have been positioned as potential treatments (dexamethasone, tocilizumab, baricitinib), however, other drugs with therapeutic potential are being investigated, such as Polymerized type I collagen (Fibroquel). Material and methods: Adult patients are admitted to the study from December 2020 to January 2021, with prior informed consent, carriers of viral pneumonia confirmed by axial tomography, secondary to infection by Sars Cov2 virus identified by RT-PCR or antigen test, who also present severity data (dyspnea, desaturation -saturation at room air of 92% or less-, persistent fever), as well as inflammation markers (D-dimer 1000ng/ml±100; ferritin> 300mg) and that allow treatment with Polymerized type I collagen (Fibroquel®) at home or in a hospital area. Results: We include data from 35 patients, 19 (54.3%) women and 16 (45.7%) men, with a median age of 51.0 (38.0-76.0) years. The number of patients with a history of previous comorbidities was 34 (97.1%) and 20 (57.1%) had multiple comorbidities (3 or more synchronous comorbidities). The most frequent comorbidities among these patients were obesity in 94.3%, DM2 62.9%, Arterial hypertension 60.0%, COPD 14.3%, heart disease 8.6%, nephropathy 5.7%, in addition to SLE and trisomy 21, both in 2.9% of patients. In the baseline evaluation laboratory, we found that 33 (94.3%) patients had lymphocytopenia and 3 (8.6%) had thrombocytopenia. Median D-Dimer and Ferritin serum levels were 1,200.0 (990.0- 1,800.0) ng/mL and 394.5 (320.0-492.5) ug/L, respectively. The neutrophil-lymphocyte index was calculated, which on average was 10.8 (8.0 - 14.7) and an ABC-GOALSclx index of 14.0 (11.0 - 16.0) was calculated, which translate severe disease and an indication of stay in an intensive care unit. Relation to the pulse oximetry at ambient air in the baseline evaluation, we found that the median O2 saturation was 88.0% (86.0% - 89.0%). The median number of days of evolution from the onset of symptoms to the moment in which treatment with Fibroquel was started was 8.0 (7.0-9.0) days. The pulse oximetry quantified 7 days after the start of treatment had a median of 94.0% (93.0-95.0%); Regarding the measurement of prognostic biomarkers, the median d-dimer and ferritin in serum measured at 7 days of follow-up were 656.0 (497.0 - 697.5) ng/mL and 394.5 (320.0-492.5) ug/L, respectively. Conclusion: Polymerized type I collagen (Fibroquel) is an effective drug in patients with inflammatory and hypoxemic pneumonia secondary to Sars COV 2 infection, favoring clinical improvement and favoring extubation, oxygenation, and inflammation indices, as well as a biosafety profile that ensures its use without restrictions in these patients.

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