A Proof of Concept Study on the Comfort and Usability of a Supportive Pillow for Pregnant Patients with COVID-19 Acute Respiratory Distress Syndrome.

Background: The prone position has been seen to benefit patients experiencing acute respiratory distress syndrome. However, performing this position in pregnant patients has been difficult and raises safety concerns. Objective: The current study aimed to test the use of a supportive pillow (Prone Pillow for Pregnant Patients or 4P) to address concerns regarding pregnant patients in prone position. Methods: The study prospectively evaluated the use of the prone pillow for patient comfort and usability among healthcare workers with qualitative and quantitative measures. Results: A total of three patients were recruited alongside 16 healthcare workers assisting pregnant patients to the prone position. Overall, awake pregnant patients found the pillow to be comfortable while healthcare workers perceived the pillow to be useful in improving quality of care among awake and intubated pregnant patients. CONCLUSION: The 4P is a potentially useful and beneficial product in placing pregnant patients in the prone position during episodes of acute respiratory distress. However, due to the limited sample size, more clinical trials are needed to evaluate the impact of this innovation in improving patient and healthcare worker safety.

Intravenous Tocilizumab versus Standard of Care in the Treatment of Severe and Critical COVID-19-related Pneumonia: A Single-center, Double-blind, Placebo-controlled, Phase 3 Trial.

Background: Severe and critical COVID-19 disease is characterized by hyperinflammation involving pro-inflammatory cytokines, particularly IL-6. Tocilizumab is a monoclonal antibody that blocks IL-6 receptors. Objectives: This study evaluated the efficacy of tocilizumab in Filipino patients with severe to critical COVID-19 disease. Methods: This phase 3 randomized double-blind trial, included patients hospitalized for severe or critical COVID-19 in a 1:1 ratio to receive either tocilizumab plus local standard of care or placebo plus standard of care. Patients were eligible for a repeat IV infusion within 24-48 hours if they deteriorated or did not improve. Treatment success or clinical improvement was defined as at least two categories of improvement from baseline in the WHO 7-point Ordinal Scale of patient status, in an intention-to-treat manner. Results: Forty-nine (49) patients were randomized in the tocilizumab arm and 49 in the placebo arm. There was no significant difference in age, comorbidities, COVID-19 severity, need for mechanical ventilation, presence of acute respiratory distress syndrome, or biomarker levels between groups. Use of adjunctive therapy was similar between groups, with corticosteroid used in 91.8% in tocilizumab group and 81.6% in the placebo group, while remdesivir was used in 98% of participants in both groups.There was no significant difference between groups in terms of treatment success in both the intention-to-treat analysis (relative risk=1.05, 95% CI: 0.85-1.30) and per-protocol analysis (relative risk=0.98, 95% CI: 0.80 to 1.21). There was no significant difference in time to improvement of at least two categories relative to baseline on the 7-point Ordinal Scale of clinical status. Conclusion: The use of tocilizumab on top of standard of care in the management of patients with severe to critical COVID-19 did not result in significant improvement as defined by the WHO 7-point Ordinal Scale of patient status, nor in significant improvement in incidence of mechanical ventilation, incidence of ICU admission, length of ICU stay, and mortality rate.

Clinical Outcomes of COVID-19 Infection among Patients with Chronic Obstructive Pulmonary Disease: Findings from the Philippine CORONA Study.

BACKGROUND: The global pandemic caused by the coronavirus disease 2019 (COVID-19) resulted in many deaths from fulminant respiratory failure. Chronic obstructive pulmonary disease (COPD) is the leading cause of morbidity and mortality worldwide. There has been great concern regarding the impact of COPD on the COVID-19 illness. METHODS: Data from the Philippine CORONA study were analyzed to determine the association of COPD and COVID-19 in terms of mortality, disease severity, respiratory failure, mechanical ventilation, and lengths of stay in the intensive care unit (ICU) and hospital. RESULTS: A total of 10,881 patients were included in this study, and 156 (1.4%) patients had been diagnosed with COPD. A majority of COVID-19 patients with COPD had other existing comorbidities: hypertension, diabetes mellitus, chronic cardiac disease, and chronic kidney disease. COPD patients were 2.0× more likely to present with severe to critical COVID-19 disease. COVID-19 patients with COPD in our study have a 1.7× increased mortality, 1.6× increased respiratory failure, and 2.0× increased risk for ICU admission. Smokers with COVID-19 were 1.8× more likely to present with more severe disease and have a 1.9× increased mortality. CONCLUSION: Our study supports the growing evidence that COPD among COVID-19 patients is a risk factor for higher mortality, more severe form of COVID-19, higher ICU admission, and higher respiratory failure needing ventilatory support.

Utility of laboratory and immune biomarkers in predicting disease progression and mortality among patients with moderate to severe COVID-19 disease at a Philippine tertiary hospital.

Purpose: This study was performed to determine the clinical biomarkers and cytokines that may be associated with disease progression and in-hospital mortality in a cohort of hospitalized patients with RT-PCR confirmed moderate to severe COVID-19 infection from October 2020 to September 2021, during the first wave of COVID-19 pandemic before the advent of vaccination. Patients and methods: Clinical profile was obtained from the medical records. Laboratory parameters (complete blood count [CBC], albumin, LDH, CRP, ferritin, D-dimer, and procalcitonin) and serum concentrations of cytokines (IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-18, IFN-γ, IP-10, TNF-α) were measured on Days 0-3, 4-10, 11-14 and beyond Day 14 from the onset of illness. Regression analysis was done to determine the association of the clinical laboratory biomarkers and cytokines with the primary outcomes of disease progression and mortality. ROC curves were generated to determine the predictive performance of the cytokines. Results: We included 400 hospitalized patients with COVID-19 infection, 69% had severe to critical COVID-19 on admission. Disease progression occurred in 139 (35%) patients, while 18% of the total cohort died (73 out of 400). High D-dimer >1 µg/mL (RR 3.5 95%CI 1.83-6.69), elevated LDH >359.5 U/L (RR 1.85 95%CI 1.05-3.25), lymphopenia (RR 1.91 95%CI 1.14-3.19), and hypoalbuminemia (RR 2.67, 95%CI 1.05-6.78) were significantly associated with disease progression. High D-dimer (RR 3.95, 95%CI 1.62-9.61) and high LDH (RR 5.43, 95%CI 2.39-12.37) were also significantly associated with increased risk of in-hospital mortality. Nonsurvivors had significantly higher IP-10 levels at 0 to 3, 4 to 10, and 11 to 14 days from illness onset (p<0.01), IL-6 levels at 0 to 3 days of illness (p=0.03) and IL-18 levels at days 11-14 of illness (p<0.001) compared to survivors. IP-10 had the best predictive performance for disease progression at days 0-3 (AUC 0.81, 95%CI: 0.68-0.95), followed by IL-6 at 11-14 days of illness (AUC 0.67, 95%CI: 0.61-0.73). IP-10 predicted mortality at 11-14 days of illness (AUC 0.77, 95%CI: 0.70-0.84), and IL-6 beyond 14 days of illness (AUC 0.75, 95%CI: 0.68-0.82). Conclusion: Elevated D-dimer, elevated LDH, lymphopenia and hypoalbuminemia are prognostic markers of disease progression. High IP-10 and IL-6 within the 14 days of illness herald disease progression. Additionally, elevated D-dimer and LDH, high IP-10, IL-6 and IL-18 were also associated with mortality. Timely utilization of these biomarkers can guide clinical monitoring and management decisions for COVID-19 patients in the Philippines.

Body Composition of Filipino Chronic Obstructive Pulmonary Disease (COPD) Patients in Relation to Their Lung Function, Exercise Capacity and Quality of Life.

Background and objectives: The loss of muscle or fat free mass (FFM) as a result of systemic inflammation and poor nutrition in Chronic Obstructive Pulmonary Disease (COPD), is recognized as an important factor that influences symptoms and disease-related outcomes. To date, there are no data on body composition among Filipino COPD patients and how it impacts COPD disease severity. This paper examined the relationship of Fat Free Mass Index (FFMI = FFM/height) and sarcopenia with COPD disease severity variables. Methods: This was a cross-sectional analytic study comparing low and normal FFMI, sarcopenic and nonsarcopenic COPD patients, in terms of lung function, exercise capacity, and quality of life score. Filipino COPD patients older than 40 years were included. Patients performed six minute walking distance (6MWD), handgrip strength (HGS), and quality of life status evaluation using Filipino version of COPD Assessment Test (CAT). Body composition was measured using bioelectrical impedance analysis (BIA). Results: A total of 41 patients were included. The mean age was 69.22 years. The prevalence of being underweight and having sarcopenia was 32% and 46%, respectively. Point biserial correlation showed that COPD patients with low FFMI had a statistically significant reduction in peak inspiratory flow (r= -0.5791, P value 0.0002), peak expiratory flow (r= -0.4475, P value 0.0055), and handgrip strength (r= -0.4560, P value 0.0027); and lower CAT score (r= -0.3422, P value 0.0285). Similar findings were observed among sarcopenic COPD patients. Conclusion: The prevalence of being underweight and having sarcopenia was high. Low FFMI results in reduction of lung function and upper limb muscle strength among Filipino COPD patients.