Trial NCT04261517
Publication Chen J, J Zhejiang Univ, 2020
Dates: 06feb2020 to 25feb2020
Funding: Public/non profit (Shanghai Public Health Clinical Center )
| Methods | |
| RCT | |
| Location :
Single center / China Follow-up duration (days): 14 | |
| Inclusion criteria | Age >=18 years, COVID-19 was diagnosed according to the "diagnosis and treatment plan" and informed consent was signed. |
| Exclusion criteria | (1) Patients who are allergic to chloroquine and hydroxychloroquine; (2) Pregnant women; (3) Patients with serious diseases such as heart, lung, kidney, brain, blood and other organs with insufficiency; (4) Retinal disease, hearing loss or hearing loss Patients; (5) Patients with severe neurological or psychiatric disorders; (6) Researchers who believe that they cannot complete the study as required or are not suitable to participate in the research. |
| Interventions | |
| Treatment
Hydroxychloroquine (400mg) Co-Intervention: Standard care Duration : 5 days |
|
| Control
Standard care Definition of Standard care: "Both groups received conventional treatment: including bed rest, oxygen inhalation, and symptomatic supportive treatment. Viral drugs such as alpha interferon nebulization, oral lopinavir / ritonavir (clepivir), etc., and antibacterial drugs are given if necessary. All patients received alpha interferon nebulization, while 12 (8*.*%) of the experimental group received abidol; 1* of the control group (66.7%) received abidol, and 2 (13.3%) Received lopinavir / ritonavir treatment." | |
| Participants | |
| Randomized 30 participants (n1=15 / n2= 15) | |
| Characteristics of participants N=30 Mean age : 49 21 males Severity : Mild: n=0 / Moderate: n=30/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 3 [ Time Frame: 3 days after randomization ]The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 5 [ Time Frame: 5 days after randomization ]The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at day 7 [ Time Frame: 7 days after randomization ]The mortality rate of subjects at weeks 2 [ Time Frame: 14 days after randomizatio | |
| In the report Virological clearance of a throat swab, sputum, or lower respiratory tract secretion on day 7 or death of the patient within 2 weeks | |
| Documents avalaible |
Protocol No Statistical plan No Data-sharing stated NR |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
High |
| General comment | In addition to the published article, the study registry was used in data extraction and risk of bias assessment. The extraction was based on the translation of the article to English by using an online translation tool. There is no change from the trial registration in the intervention and control treatments. The outcomes indicated in registry reflect the outcomes reported in the paper. On July 9th, 2020 we received additional information from authors on this study.On July 9th, 2020 we received additional information from authors on this study. |