[Initiatives, Outcomes, and Facilitating Factors to Changing Workplace Environments in Small- and Medium-sized Enterprises due to the COVID-19 Pandemic: Interviews with Employers and Human Resource Managers].

OBJECTIVES: This study identified changes in the work environment due to the COVID-19 pandemic, subsequent initiatives and outcomes, and facilitating factors from the perspective of company officials in small- and medium-sized enterprises (SMEs). METHODS: In 2021, semi-structured interviews were conducted with employers or human resource managers of SMEs with less than 300 employees regarding changes in the work environment due to the pandemic, initiatives, outcomes, and facilitating factors. Thereafter, codes were extracted from verbatim transcripts or interview notes and categorized based on similarities in content. RESULTS: Based on interviews with 16 companies, the following four major categories of changes in the work environment were identified: "conflict and anxiety about infection when employees were forced to attend work despite the rapid transmission of the infection," "unfamiliarity and loneliness with the new working style that was suddenly imposed on them," "loss of emotional ties with workmates and opportunities for mood changes," and "future anxiety, feelings of alienation, and mental illness." The following seven initiatives were implemented to address these issues: "a hands-on approach to infection prevention and physical healthcare," "urgent introduction of telework for business continuity," "development and promotion of online information sharing," "establishment of a place and opportunity to maintain emotional connections within the company," "economic and management measures to protect employees and ensure company continuity," "support for employees for health maintenance," and "measures to respond to employees' needs and ideas, and support the continuation of activities." Four major categories of outcomes were: "increased efficiency of information sharing and enhanced performance," "maintenance and promotion of emotional ties and a sense of solidarity," "increased independence and sense of health among employees," and "adaptation of employees to novel situations." The initiatives were facilitated by factors classified into the following three major categories: "workplace culture wherein employees shared opinions and helped each other," "management's attitude and philosophy of valuing employees," and "proactive attitude toward information acquisition and resource utilization." CONCLUSION: The rapid introduction of teleworking as a new working style in response to the need to balance infection control and business continuity resulted in increased loneliness and other associated stressors. Many SMEs stated that they could maintain a sense of solidarity in the workplace and improve employee autonomy through their efforts to incorporate employees' opinions and maintain human connections.

Phase II Clinical Trial of Combination Therapy with Favipiravir and Methylprednisolone for COVID-19 with Non-Critical Respiratory Failure.

INTRODUCTION: The administration of systemic corticosteroids is a key strategy for improving COVID-19 outcomes. However, evidence is lacking on combination therapies of antiviral agents and systemic corticosteroids. The objective of this study was to investigate the efficacy and safety of the combination therapy of favipiravir and methylprednisolone in preventing respiratory failure progression in patients with COVID-19 and non-critical respiratory failure. METHODS: We conducted a multicenter, open-label, single-arm phase II study. The patients received favipiravir 3600 mg on the first day, followed by 1600 mg for a total of 10-14 days. Methylprednisolone was administered intravenously at 1 mg/ideal body weight (IBW)/day from days 1 to 5, followed by 0.5 mg/IBW/day from days 6 to 10 if clinically indicated. The primary endpoint was the proportion of patients requiring mechanical ventilation (MV) (including noninvasive positive pressure ventilation) or those who met the criteria for tracheal intubation within 14 days of the study treatment initiation (MVCTI-14). RESULTS: Sixty-nine patients were enrolled and underwent the study treatment. Of them, the MVCTI-14 proportion was 29.2% (90% confidence interval 20.1-39.9, p = 0.200). The proportion of patients who required MV or who died within 30 days was 26.2%, and 30-day mortality was 4.9%. The most significant risk factor for MVCTI-14 was a smoking history (odds ratio 4.1, 95% confidence interval 1.2-14.2). The most common grade 3-4 treatment-related adverse event was hyperglycemia, which was observed in 21.7%. CONCLUSION: The MVCTI-14 proportion did not reach a favorable level in the clinical trial setting with the threshold of 35%. However, the proportion of MV or death within 30 days was 26.6%, which might be close to the findings (28.1%) of the RECOVERY trial, which showed the efficacy of dexamethasone for patients with COVID-19 and non-critical respiratory failure. Further evaluation of this combination therapy is needed. CLINICAL TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) identifier jRCTs041200025.