Efficacy of Early Treatment With Favipiravir on Disease Progression Among High-Risk Patients With Coronavirus Disease 2019 (COVID-19): A Randomized, Open-Label Clinical Trial.

BACKGROUND: The role of favipiravir in preventing disease progression in coronavirus disease 2019 (COVID-19) remains uncertain. We aimed to determine its effect in preventing disease progression from nonhypoxia to hypoxia among high-risk COVID-19 patients. METHODS: This was an open-label, randomized clinical trial conducted at 14 public hospitals across Malaysia (February-July 2021) among 500 symptomatic, RT-PCR-confirmed COVID-19 patients, aged ≥50 years with ≥1 comorbidity, and hospitalized within first 7 days of illness. Patients were randomized 1:1 to favipiravir plus standard care or standard care alone. Favipiravir was administered at 1800 mg 2×/day on day 1 followed by 800 mg 2×/day until day 5. The primary endpoint was rate of clinical progression from nonhypoxia to hypoxia. Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, and in-hospital mortality. RESULTS: Of 500 patients randomized (mean [SD] age, 62.5 [8.0] years; 258 women [51.6%]; 251 [50.2%] had COVID-19 pneumonia), 487 (97.4%) patients completed the trial. Clinical progression to hypoxia occurred in 46 (18.4%) patients on favipiravir plus standard care and 37 (14.8%) on standard care alone (OR, 1.30; 95% CI: .81-2.09; P = .28). All 3 prespecified secondary endpoints were similar between both groups. Mechanical ventilation occurred in 6 (2.4%) vs 5 (2.0%) (OR, 1.20; 95% CI: .36-4.23; P = .76), ICU admission in 13 (5.2%) vs 12 (4.8%) (OR, 1.09; 95% CI: .48-2.47; P = .84), and in-hospital mortality in 5 (2.0%) vs 0 (OR, 12.54; 95% CI: .76-207.84; P = .08) patients. CONCLUSIONS: Among COVID-19 patients at high risk of disease progression, early treatment with oral favipiravir did not prevent their disease progression from nonhypoxia to hypoxia. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov (NCT04818320).

Reduction of central-line-associated bloodstream infection (CLABSI) in resource limited, nonintensive care unit (ICU) settings.

PURPOSE: There was limited study available on successful intervention for central-line-associated bloodstream infection (CLABSI) done at nonintensive care unit (ICU) and resources-limited setting. The objective of this study was to design, implement and evaluate a strategy to reduce CLABSI rate in non-ICU settings at general medical wards of Hospital Tuanku Ja'afar Seremban. DESIGN/METHODOLOGY/APPROACH: Preinterventional study was conducted in one-month period of January 2019, followed by intervention period from February to March 2019. Postintervention study was conducted from April to July 2019. The CLABSI rates were compared between pre and postintervention periods. A multifaceted intervention bundle was implemented, which comprised (1) educational program for healthcare workers, (2) weekly audit and feedback and (3) implementation of central line bundle of care. FINDINGS: There was a significant overall reduction of CLABSI rate between preintervention and postintervention period [incidence rate ratio (IRR) of 0.06 (95 percent CI, 0.01-0.33; P = 0.001)]. PRACTICAL IMPLICATIONS: CLABSI rates were reduced by a multifaceted intervention bundle, even in non-ICU and resource-limited setting. This includes a preinterventional study to identify the risk factors followed by a local adaption of the recommended care bundles. This study recommends resources-limited hospitals to design a strategy that is suitable for their own local setting to reduce CLABSI. ORIGINALITY/VALUE: This study demonstrated the feasibility of a multifaceted intervention bundle that was locally adapted with an evidence-based approach to reduce CLABSI rate in non-ICU and resource-limited setting.