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BackgroundTo analyze the characteristics and heterogeneity of clinical trials of Novel Coronavirus(COVID-19) registered in the China Clinical Trial Registry (ChiCTR), and provide data bases and information references for clinical treatment MethodsStatistics of COVID-19 clinical trials registered with ChiCTR as of February 24, 2020 were collected. Descriptive analysis of registration characteristics. The chi-square test is used to compare statistical differences between different study types, intervention methods, study stage, and Primary sponsor. Results232 COVID-19 studies registered at the ChiCTR were collected. The overall number of COVID-19 registrations was increased. Hubei Province, China has the largest number of registrations. There were significant differences between the number of participants(P=0.000), study duration(P=0.008), study assignment(P=0.000), and blind method(P=0.000) for different study types. Significant differences could be seen in the dimensions of multicenter study(P=0.022), of participants numbe(P=0.000), study duration(P=0.000) and study assignment(P=0.001) for the four intervention methods. There were significant differences in study assignment(P=0.043) between the early and late studies. CMT drugs with high research frequency are chloroquine, lopinavir / ritonavir, and I-IFN; BI was Cell therapy, plasma therapy, Thymosin, and M/P-AB. ConclusionsDifferent study design characteristics have led to significant differences in some aspects of the COVID-19 clinical trial. Timely summary analysis can provide more treatment options and evidence for clinical practice.
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Objective Pulmonary function testing is a commonly used indicator for clinical evaluation of the degree of pulmonary fibrosis in patients. This paper aims to investigate the dynamic changes of lung function in mice with pulmonary fibrosis and to establish a range of reference values for lung function parameters in normal Kunming mice. Methods Twenty-eight SPF Kunming mice were randomly divided into normal control group (n=14) and model group (n=14). After anesthesia with 10% chloral hydrate, the normal control group only underwent tracheal puncture. The model group received intratracheal puncture and injection of bleomycin (BLM) (5 mg/kg body weight), and the lung function indicators of all mice were detected in the same order on the 1st, 2nd, 3rd and 4th weekends after modeling: Ti, Te, PIF, PEF, TV, EV, RT, MV, f, Penh and EF50. Results After intratracheal BLM injection, mice in the model group showed decreased hair softness and smoothness, hair loss and decreased activity after the 2nd week. Compared with the control group, Ti, Te and RT values in the model group significantly increased at week 4 (P<0.05), while the values of PEF, RT, MV, f and EF50 decreased significantly at the same week (P<0.05). Compared with the model group at week 1, the differences in Ti, Te, RT and f values at week 2, 3 and 4 were statistically significant (P<0.05); the differences in MV and EF50 values at week 3 and 4 were statistically significant (P<0.05); while the PIF values only showed differences at week 4 (P<0.001). Compared with the Penh values in the control group at week 2, 3 and 4 (0.553±0.189, 0.662±0.164, 0.712±0.189), the differences of the model group (0.820±0.205, 0.936±0.188, 1.053±0.236) showed statistical significance (P<0.001). Compared with the model group at week 1, the differences of Penh values in the model group only showed statistical significance at week 3 and 4 (P<0.05). Through four-week lung function test, various parameters were obtained, among which the normal range of the main index Penh value was 0.27-0.88. Conclusion The lung function detected by the non-invasive whole body plethysmography system was stable and reliable with good effects; the lung function in mice with the BLM-induced pulmonary fibrosis continued to decrease within four weeks. Penh, which reflects airway resistance, can be used for overall screening of the lung function among the test mice after two weeks of modeling.
