RESUMO
Background: The global COVID-19 pandemic led to substantial clinical and economic outcomes with catastrophic consequences. While the majority of cases has mild to moderate disease, minority of patients progress into severe disease secondary to the stimulation of the immune response. The hyperinflammatory state contributes towards progression into multi-organ failure which necessitates suppressive therapy with variable outcomes. This study aims to explore the safety and efficacy of anakinra in COVID-19 patients with severe disease leading to cytokine release syndromes. Methods: In this open-label, multi-center, randomized clinical trial, patients with confirmed COVID-19 infection with evidence of respiratory distress and signs of cytokine release syndrome were randomized in 1:1 ratio to receive either standard of care (SOC) or anakinra (100 mg subcutaneously every 12 h for 3 days then 100 mg subcutaneously once daily for 4 days) in addition to SOC. The primary outcome was treatment success at day 14 as defined by the WHO clinical progression score of ≤3. Primary analysis was based upon intention-to-treat population, with value of p of <0.05. Results: Out 327 patients screened for eligibility, 80 patients were recruited for the study. The mean age was 49.9 years (SD = 11.7), with male predominance at 82.5% (n = 66). The primary outcome was not statistically different (87.5% (n = 35) in anakinra group vs. 92.5% (n = 37) in SOC group, p = 0.712; OR = 1.762 (95%CI: 0.39-7.93). The majority of reported adverse events were mild in severity and not related to the study treatment. Elevated aspartate aminotransferase was the only significant adverse event which was not associated with discontinuation of therapy. Conclusion: In patients with severe COVID-19 infection, the addition of anakinra to SOC treatment was safe but was not associated with significant improvement according to the WHO clinical progression scale. Further studies are warranted to explore patients' subgroups characteristics that might benefit from administered therapy. Clinical Trial Registration: Trial registration at ClinicalTrials.gov, identifier: NCT04643678.
RESUMO
Pharmacists play a key role in tackling antibiotic misuse through counseling and education of patients and healthcare providers. The study aim is to evaluate the appropriateness of antibiotic prescriptions in community pharmacy settings while implementing an interventional call-back service to assess adherence and symptom resolution among patients prescribed an antibiotic. Patients were recruited by community pharmacists who were assigned to either the call-back, structured counseling, or standard care arms. Patients in the call-back group received intensive antibiotic counseling and a phone call from the study pharmacist 3 to 5 days after antibiotic initiation. The counseling arm patients received intensive antibiotic counseling from the study pharmacist while patients in the standard care arm received routine care. Antibiotic adherence rates among the standard care (n = 25), counseling (n = 29), and call-back (n = 26) groups were 64%, 86.2%, and 88.5%, respectively (X2 = 5.862, p = 0.053). Symptom severity scores after completion of antibiotic treatment among all groups were rated as excellent. Twenty-nine percent of the outpatient antibiotic prescriptions were deemed as inappropriate. A pharmacist call-back service is a simple and inexpensive intervention which can effectively identify opportunities for improving appropriate antibiotic use, particularly with respect to adherence.
