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Table 1 presents the demographic and clinical characteristics of the 131 confirmed cases (69% male, 31% female), who were admitted to Jin-Yin-Tan Hospital between 30 December, 2019 and 15 January, 2020 with mean 9 (± 3.9) days after onset of symptom. The average age was 51.4 (± 11.8) years and 17.5% patients were older than 60. All patients were residents of Wuhan or surrounding areas. 75 (57%) patients had a history of exposure to the Huanan Seafood Market, 12 (9%) cases had exposure to patients with confirmed or highly suspected COVID-19, and 9 (7%) patients were clustered onset. Among those 131 patients, 55 (42%) had underlying chronic diseases, including 31 (24%) hypertension, 14 (11%) diabetes and 7 (5%) with chronic heart disease.
Clinical characteristics (n = 131) Sex (Male/Female) 90 (68.7%)/41 (31.3%) Age, years 51.4 ± 11.8 (24–81) Age range, years 24–39 19 (14.5%) 40–59 76 (58.0%) 60–79 35 (16.7%) ≥ 80 1 (0.8%) Days from onset to hospitalization 9.04 ± 3.93 (1–24) Time of staying in hospital (days) 18.26 ± 10.06 (4–72) Normal/severe/critical cases 15 (11.4%)/82 (62.6%)/34 (26.0%) Comorbidities 55 (42%) Hypertension 31 (23.7%) Diabetes mellitus 14 (10.7%) Heart disease 7 (5.3%) Epidemiologic history History of residence or travel 131 (100%) Exposure to Huanan Seafood Wholesale Market 75 (57.3%) History of contacting with COVID-19 patients 12 (9.2%) Clustered onset 9 (6.9%) Onset symptoms Fever 124 (94.7%) Cough 96 (73.3%) Dyspnea 50 (38.2%) Fatigue 43 (32.8%) Shortness of breath 33 (25.2%) Gasping 22 (16.8%) Muscle ache 20 (15.3%) Headache 15 (11.5%) Chill 12 (9.2%) Chest pain 7 (5.3%) Nausea 5 (3.8%) Dizziness 5 (3.8%) Sore throat 4 (3.1%) Runny nose 4 (3.1%) Difficulty breathing 4 (3.1%) Joint soreness 4 (3.1%) Palpitations 3 (2.3%) Vomit 3 (2.3%) Shivering 3 (2.3%) Diarrhea 2 (1.5%) Treatment Glucocorticoids 64 (48.9%) Immunoglobulin 19 (14.5%) High-flow Nasal Cannula 33 (25.2%) Non-invasive ventilation 16 (12.2%) Invasive ventilation 7 (5.3%) Extracorporeal membrane oxygenation 4 (3.1%) Renal replacement therapy 6 (4.6%) Blood transfusion 4 (3.1%) Vasoconstrictive agents 4 (3.1%) Complication 72 (55.0%) Liver dysfunction 48 (36.6%) Acute respiratory distress syndrome 40 (30.5%) Hypoproteinemia 34 (26.0%) Sepsis 18 (13.7%) Thrombocytopenia 16 (12.2%) Acute kidney injury 13 (9.9%) Septic shock 11 (8.4%) Acute myocardial injury 9 (6.9%) In-hospital mortality 15 (11.5%) Table 1. Demographics and clinical characteristics of the included patients.
The most common symptoms at admission were fever (124, 94.7%), cough (96, 73.3%) and dyspnea (50, 38.2%). A few patients presented atypical onset symptoms, including headache (15, 12%), dizziness (5, 4%), nausea (5, 4%), vomit (3, 2%) and diarrhea (2, 1.5%). Almost half of the patients (64, 49%) received glucocorticoids, 19 (14.5%) cases received human immunoglobulin; 33 (25.5%) patients were treated with high-flow nasal cannula, 23 (17.6%) with mechanical ventilation, 4 (3.1%) with extracorporeal membrane oxygenation (ECMO), 6 (4.6%) with renal replacement therapy, and 4 (3.1%) with vasoconstrictive agents.
More than half (72, 55.5%) of the patients had damage in organ function, including 48 (36.6%) with liver dysfunction, 40 (30.5%) with ARDS, 13 (9.9%) with acute kidney injury, 11 (8.4%) with septic shock, and 9 (6.9%) with acute cardiac injury. Most of the patients (82, 62.6%) were severe cases and a quarter of patients were critical cases according to the clinical classification defined by General Office of National Health Committee of China (General Office of National Health Committee 2020). Fifteen (11.5%) of those patients died during hospitalization (Table 1).
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The majority of the patients had a normal white blood cell count (88/131, 67.2%) and normal procalcitonin (123/128, 96.1%). More than half of the patients had a reduced lymphocyte count (83/131, 63.4%), and increased indicators of inflammation, including ESR (120/127, 94.5%), C-reactive protein (107/128, 83.6%), interleukin 6 (49/97, 50.5%), LDH (85/128, 66.4%) and ferritin (86/119, 72.3%). Some patients showed abnormal coagulation function index, including increased fibrinogen (92/124, 74.2%) and increased D-Dimer (20/123, 16.3%) (Table 2).
Parameter White blood cell count, × 109/L 6.02 ± 3.30 < 3.5 25/131 (19.1%) 3.5 ~ 9.5 88/131 (67.2%) > 9.5 18/131 (13.7%) Neutrophil count, × 109 /L 4.66 ± 3.38 Lymphocyte count, × 109 /L 1.00 ± 0.52 < 1.1 83/131 (63.4%) ≥ 1.1 48/131 (36.6%) C-reactive protein, mg/L < 5 21/128 (16.4%) ≥ 5 107/128 (83.6%) Procalcitonin, ng/mL < 0.5 123/128 (96.1%) ≥ 0.5 5/128 (3.9%) ESR, mm/h 49.82 ± 5.06 < 15 7/127 (5.5%) ≥ 15 120/127 (94.5%) Interleukin6, pg/mL 8.10 ± 5.80 < 7 48/97 (49.5%) ≥ 7 49/97 (50.5%) Ferritin, ng/mL < 274.66 33/119 (27.7%) ≥ 274.66 86/119 (72.3%) LDH, mmol/L 326.14 ± 113.74 < 250 43/128 (33.6%) ≥ 250 85/128 (66.4%) FIB, g/L 5.26 ± 1.91 < 2 3/124 (2.4%) 2 ~ 4 29/124 (23.4%) ≥ 4 92/124 (74.2%) D-Dimer, mg/L < 1.5 103/123 (83.7%) ≥ 1.5 20/123 (16.3%) Continuous data are expressed as mean ± SD. Categorical data are presented as n/N (%), where N is the total number of patients with available data. Table 2. Laboratory parameters.
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All patients had been chest CT scanned at outpatients department or at other hospitals before admission. All of them were reported with lung infection and, most likely, the viral pneumonia. 124 cases were re-conducted chest CT scan during hospitalization after 15 (± 5.4) days from onset. All chest CT images showed abnormalities, ground glass opacity and infiltrates shadows or consolidation. The majority of the patients presented bilateral, multifocal lung lesions, with peripheral distribution. Pleural effusion were uncommon imaging findings in those patients.
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The sensitivities of the IgG and IgM ELISA detection in serum samples obtained from patients at different periods after disease onset are shown in Table 3. The overall sensitivities of IgG ELISA (92.5%) were significantly higher than that of IgM ELISA (70.8%) (P < 0.001). In addition, the sensitivity of IgG ELISA in different periods after disease onset (5–10, 11–20 and 31–40 days) were generally higher than that of IgM ELISA, except for the equivalent from 31 to 40 days (P > 0.05) (Table 3). The mean OD450 values of IgM and IgG for 226 serum samples obtained from the 131 confirmed COVID-19 cases were 0.391 and 1.565, with standard deviations of 0.496 and 0.722 respectively (Table 3). For IgG, the mean OD450 values significantly increased to 1.683 during 11 to 20 days after onset, and then maintained relatively high (Table 3). For IgM, however, the OD450 values reached the peak of 0.435 during 21 to 30 days after onset and fell back to 0.187 during 31 to 40 days after onset (Table 3). The sensitivity of IgM increased if the samples were re-detected (Table 4).
Days after onset Number of samples Number of positive for IgM by ELISA Number of positive for IgG by ELISA ELISA OD ratio of IgM ELISA OD ratio of IgG 5 ~ 10 34 13 (38.2%) 22 (64.7%)* 0.202 ± 0.273 0.905 ± 0.808 11 ~ 20 151 115 (76.2%) 147 (97.4%)* 0.431 ± 0.534 1.683 ± 0.653# 21 ~ 30 35 28 (80.0%) 35 (100%)* 0.435 ± 0.493 1.686 ± 0.542# 31 ~ 40 6 4 (66.7%) 5 (83.3%) 0.187 ± 0.103 1.621 ± 0.932# 5 ~ 40 226 160 (70.8%) 209 (92.5%)* 0.391 ± 0.496 1.565 ± 0.722# *P < 0.05 versus IgM in the same period.
#P < 0.05 versus 5 to 10 days.Table 3. Differential sensitivity of ELISA for detection of IgM and IgG in different periods after disease onset.
Times of detection Number of patients Number of positive for IgM by ELISA Number of positive for IgG by ELISA 1 36 26 (72.2%) 35 (97.2%) 2 95 87 (91.6%)* 94 (98.9%) Total 131 113 (86.3%) 129 (98.5%) *P < 0.05 versus once. Table 4. Differential sensitivity of ELISA for detection of IgM and IgG with different times in COVID-19 patients.
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Among the 131 confirmed cases, 16 cases were in hospital varying 30 to 60 days after onset of illness, whereas 109 patients were discharged within 30 days after onset. 115 patients survived. The median OD450 results from the available serum specimens of all patients were calculated and were plotted as a function of the days from onset of symptoms (Fig. 1). For IgM, the median OD450 rose above the baseline level at day 6 (seroconversion time), peaked at around day 18, and fell to below the baseline level at about day 36. The seroconversion time of IgG was 3 days. The IgG antibody level peaked at around 23 days, and then maintained relatively high (Fig. 1). IgG antibodies in 3 of 95 patients converted from positive to negative after 5 days (detected twice) (Table 5). Two of these three patients had only mild symptom but the third one presented critical situation and later died in hospital.
Negative to positive Positive to negative Positive twice Negative twice Number (%) of IgM change 30 (31.6%) 10 (10.5%) 47 (49.5%) 8 (8.4%) Number (%) of IgG change 11 (11.6%) 3 (3.2%) 80 (84.1%) 1 (1.1%) Table 5. Dynamic changes of IgM and IgG in COVID-19 patients (n = 95).