chinese medicine q 14 in the treatment of patients with coronavirus disease 2019 CORD-Papers-2021-10-25 (Version 1)

Title: Chinese medicine (Q-14) in the Treatment of Patients with Coronavirus Disease 2019 (COVID-19): A Single-center, Open label, Randomised Controlled Trial
Abstract: OBJECTIVE To evaluate the efficacy and safety of Chinese medicine (Q-14) plus standard care compared with standard care alone in adult with coronavirus disease 2019 (COVID-19). Study DESIGN Single-center, open label, randomised controlled trial. SETTING Wuhan Jinyintan Hospital, Wuhan, China, February 27 to March 27, 2020. PARTICIPANTS 204 patients with laboratory confirmed COVID-19 were randomised in to treatment group and control group, which was 102 patients each group. INTERVENTIONS In treatment group, Q-14 was administrated at 10g (granules), twice daily for 14 days and plus standard care. In control group, patients were given standard care alone for 14 days. MAIN OUTCOME MEASURE The primary outcome was conversion time of SARS-CoV-2 viral assay. Adverse events were analyzed in the safety population. RESULTS Among 204 patients, 195 were analyzed according to the intention to treat principle. There were 149 patients (71 vs. 78 in treatment group and control group respectively) turning to negative via SARS-CoV-2 viral assay. No statistically significance showed in conversion time between treatment group and control group (FAS: Median (IQR): 10.00 (9.00-11.00) vs. 10.00 (9.00-11.00); Mean rank: 67.92 vs. 81.44; P=0.051.). Time to recovery of fever was shorter in treatment group as compared in control group. The disappearance rate of symptom in cough, fatigue, chest discomfort was significantly higher in treatment group. In chest computed tomography (Chest CT) examinations, overall evaluation of chest CT examination after treatment compared with baseline showed more patients improved in treatment group .There were no significant differences in the other outcomes. CONCLUSION Administration of Q-14 on standard care for COVID-19 was useful for improvement of symptoms (such as fever, cough, fatigue and chest discomfort), while did not result in a significantly higher probability of negative conversion of SARS-CoV-2 viral assay. No serious adverse events were reported. TRIAL REGISTRATION ChiCTR2000030288
Published: 1/26/2021
DOI: 10.1101/2021.01.25.21249417
DOI_URL: http://doi.org/10.1101/2021.01.25.21249417
Author Name: Liu, J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/liu_j
Author Name: Yang, W
Author link: https://covid19-data.nist.gov/pid/rest/local/author/yang_w
Author Name: Liu, Y
Author link: https://covid19-data.nist.gov/pid/rest/local/author/liu_y
Author Name: Lv, C
Author link: https://covid19-data.nist.gov/pid/rest/local/author/lv_c
Author Name: Ruan, L
Author link: https://covid19-data.nist.gov/pid/rest/local/author/ruan_l
Author Name: Zhao, C
Author link: https://covid19-data.nist.gov/pid/rest/local/author/zhao_c
Author Name: Huo, R
Author link: https://covid19-data.nist.gov/pid/rest/local/author/huo_r
Author Name: Shen, X
Author link: https://covid19-data.nist.gov/pid/rest/local/author/shen_x
Author Name: Miao, Q
Author link: https://covid19-data.nist.gov/pid/rest/local/author/miao_q
Author Name: Lv, W
Author link: https://covid19-data.nist.gov/pid/rest/local/author/lv_w
Author Name: Li, H
Author link: https://covid19-data.nist.gov/pid/rest/local/author/li_h
Author Name: Shi, H
Author link: https://covid19-data.nist.gov/pid/rest/local/author/shi_h
Author Name: Hu, L
Author link: https://covid19-data.nist.gov/pid/rest/local/author/hu_l
Author Name: Yang, Z
Author link: https://covid19-data.nist.gov/pid/rest/local/author/yang_z
Author Name: Zhang, L
Author link: https://covid19-data.nist.gov/pid/rest/local/author/zhang_l
Author Name: Wang, B
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wang_b
Author Name: Dong, G
Author link: https://covid19-data.nist.gov/pid/rest/local/author/dong_g
Author Name: Xian, Y
Author link: https://covid19-data.nist.gov/pid/rest/local/author/xian_y
Author Name: Li, B
Author link: https://covid19-data.nist.gov/pid/rest/local/author/li_b
Author Name: Zhou, Z
Author link: https://covid19-data.nist.gov/pid/rest/local/author/zhou_z
Author Name: Xu, C
Author link: https://covid19-data.nist.gov/pid/rest/local/author/xu_c
Author Name: Chen, Y
Author link: https://covid19-data.nist.gov/pid/rest/local/author/chen_y
Author Name: Bian, Y
Author link: https://covid19-data.nist.gov/pid/rest/local/author/bian_y
Author Name: Guo, J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/guo_j
Author Name: Yang, J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/yang_j
Author Name: Wang, J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wang_j
Author Name: Qi, W
Author link: https://covid19-data.nist.gov/pid/rest/local/author/qi_w
Author Name: Chen, S
Author link: https://covid19-data.nist.gov/pid/rest/local/author/chen_s
Author Name: Yan, B
Author link: https://covid19-data.nist.gov/pid/rest/local/author/yan_b
Author Name: Wang, W
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wang_w
Author Name: Li, J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/li_j
Author Name: Xie, X
Author link: https://covid19-data.nist.gov/pid/rest/local/author/xie_x
Author Name: Xu, M
Author link: https://covid19-data.nist.gov/pid/rest/local/author/xu_m
Author Name: Jiang, J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/jiang_j
Author Name: Wang, G
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wang_g
Author Name: Cong, X
Author link: https://covid19-data.nist.gov/pid/rest/local/author/cong_x
Author Name: Zhu, H
Author link: https://covid19-data.nist.gov/pid/rest/local/author/zhu_h
Author Name: Shi, J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/shi_j
Author Name: Leng, L
Author link: https://covid19-data.nist.gov/pid/rest/local/author/leng_l
Author Name: Li, D
Author link: https://covid19-data.nist.gov/pid/rest/local/author/li_d
Author Name: Guo, L
Author link: https://covid19-data.nist.gov/pid/rest/local/author/guo_l
Author Name: Huang, L
Author link: https://covid19-data.nist.gov/pid/rest/local/author/huang_l
license: medrxiv
source_x: MedRxiv; WHO
source_x_url: https://www.who.int/
url: https://doi.org/10.1101/2021.01.25.21249417 http://medrxiv.org/cgi/content/short/2021.01.25.21249417v1?rss=1
has_full_text: FALSE
G_ID: chinese_medicine_q_14_in_the_treatment_of_patients_with_coronavirus_disease_2019
S2 ID: 231708627