RESUMEN
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.
Asunto(s)
COVID-19 , Interleucina-6RESUMEN
Objective@#This study aims to validate a Filipino version of the questionnaire by Delclos et al on occupational risk factors and asthma among the health care workers of the Philippine General Hospital.@*Methodology@#Forward and backward translation method for bilinguals was used in this study. The Filipino translation was administered to 110 health care workers selected by stratified random sampling. After 24 hours, the retranslated English version was given to the same respondents. Testing for internal consistency reliability was done by computing for Cronbach's alpha. Construct validity was subsequently determined using the Cramer's V Coefficient.@*Results@#The Filipino questionnaire showed good internal consistency reliability, as shown by the overall Cronbach’s alpha of 0.9016, which is comparable to that of the original version by Delclos. Likewise, our Filipino questionnaire showed good construct validity, supported by the Cramer’s V coefficients ranging from 0.2204 (strong relationship) to 0.7843 (very strong relationship).@*Conclusion@#Overall, the Filipino version of the questionnaire for work-related asthma tested among the health care workers of Philippine General Hospital showed good reliability and validity. This may now be used as screening tool for occupational asthma among health care workers who are at risk of developing the disease. In addition, this research tool may be utilized to establish the prevalence of occupational asthma in hospitals and later on, aid in the development of a better working environment for the whole health care team.