Chest CT and Clinical Features of COVID-19 Patients in the Early Stage of the Epidemic: An Observational Study from China (preprint)

Background: COVID-19 had caused more than 2.8 million deaths globally, and the epidemic will persist for an extended period of time. We analyzed clinical features of patients in the early stage of the epidemic, so as to deepen the understanding of the disease.Methods: In this retrospective study, we included 84 confirmed cases of COVID-19 during February 1, 2020 and March 31, 2020. Baseline data were used to classify patients as moderate (57%) or severe/critical based on Chinese protocol. We focused on analyzing the differences in chest computed tomography (CT) between the two groups. Results: Of the 84 cases, 50 were male and the median age was 69 years. 55 (65%) patients had comorbidities at admission, more in the severe/critical group (P=0.040). 94% patients had bilateral lesions on CT, up to 68% had lesions involving all lobes. Ground glass opacification (GGO) (96%), consolidation (44%), Linear opacities (50%) and Air bronchogram (23%) were the mainly lesions. The lesion was gradually absorbed over time, but imaging abnormalities can persist for a long time. Compared with moderate cases, the severe/critical group had more pulmonary consolidation changes (P=0.044) and significantly higher CT severity Score (CTSS) (P=0.040). Lymphocyte counts were significantly lower (P=0.011) and NLR were higher (P=0.029) in severe/critical cases. Conclusions: Chest CT showed bilateral and multiple GGO and consolidation mainly. After treatment, pulmonary lesions were gradually absorbed over time, and imaging abnormalities can be persistent for a long time. Lung consolidation, CTSS, comorbidity, lymphocyte counts, and NLR may be predictors of severe COVID-19.

Efficacy and Safety of Leflunomide for Refractory COVID-19: An Open-label Controlled Study (preprint)

OBJECTIVE To evaluate the safety and efficacy of leflunomide for the treatment of refractory COVID-19 in adult patients. DESIGN Open-label controlled study SETTING A designated hospital for patients with refractory COVID-19 in Wuhan, China. PARTICIPANTS 27 hospitalized adult patients ([≥]18 years of age) with radiologically confirmed pneumonia and SARS-CoV-2 positive for more than 28 days despite standard care were assigned to receive standard of care (SOC, grp I) or leflunomide + SOC (grp 2). After 2 weeks, grp 1 and grp 2 patients who continued to be SARS-CoV-2-positive received leflunomide for 14 days while continuing SOC. MAIN OUTCOME MEASURES The primary outcomes were the rate of and time to SARS-CoV-2 clearance and the 14-day and 30-day hospital discharge rate. RESULTS Twelve patients enrolled in grp 1 and 15 patients were in grp 2. The 14 days SARS-CoV-2 viral clearance rate was 80.0% (12/15) for grp 2 patients receiving leflunomide versus 16.7% for grp 1 patients (2/12) (P=0.002). By day 14, the median time to SARS-CoV-2 clearance was 6.0 days (range 1-12; IQR 1-12) for grp 2 patients. In grp 1, two patients converted to viral negative on days 1 and 6 (P=0.002). The 14-day discharge rate was 73.3% (11/15) for the grp 2 versus 8.3% (1/12) for grp 1 (P=0.001). The 30-day discharge rate was 100% (15/15) for the grp 2 versus 66.7% (8/12) for grp 1. No severe adverse events or deaths were reported. CONCLUSION Leflunomide is effective in enhancing SARS-CoV-2 clearance and hospital discharge in refractory COVID-19 patients. The addition of leflunomide to SOC did not increase adverse events versus SOC. These preliminary observations underscore a need for a randomized clinical study of leflunomide in SARS-CoV-2 infection.