Publication Wang D, SSRN, 2020 (preprint)
Dates: 2020-02-13 to 2020-03-13
Funding: Public/non profit (Department of Science and Technology of Anhui Province and Health Commission of Anhui Province, China National Center for Biotechnology Development)
Conflict of interest: no COI
Multicenter / China |
Follow-up duration (days): 14
|Inclusion criteria||1) 18-85 years old;
2) plasma IL-6 levels elevated;
3) moderate (with bilateral pulmonary lesions) or severe in disease degree.
|Exclusion criteria||1) woman who is pregnant or lactating;
2) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal(ULN; neutropenia < 0.5×109/L; platelet < 50×109/L;
3) people diagnosed with rheumatism- and immunity-related diseases, cancer and other related diseases;
4) people who are taking antirejection or immunomodulatory drugs;
5) people who are allergic to tocilizumab or any excipients;
6) patients with active hepatitis and tuberculosis, associated with specific bacterial and fungal infections;
7) patients who have had organ transplantation;
8) people with mental disorders
Co-Intervention: Standard care
Duration : 1 day
Definition of Standard care: Standard care was given according to the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (5th or update version)”.
65 participants (n1=33 / n2= 32)
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=0 / Moderate: n=37/ Severe: n=28 Critical: n=0
|In the register|
|In the report|
Cure rate of the enrolled patients (defined as 1)fever attenuated for continuously 7 days, 2) twice COVD-19 nucleolus acid detections negative, 3) CT scan shows chest effusion absorbed more than 50% percent when the patient is discharged from hospita
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to all available versions of the pre-print article, the study registry was used in data extraction and risk of bias assessment. The study did not achieve the target sample size specified in the registry.
Quote: "Because of the rapid decline in the number of COVID-19 patients in China, finally a total of 65 pneumonia patients with laboratory confirmed SARS-CoV-2 infection underwent randomization."
There is no change from the trial registration in the intervention and control treatments, nor in the primary outcome. Mortality was stated as a secondary outcome in the registry but not in the report. Conversely, some secondary outcomes in the report (recovery rate of hypoxia over 14 days and the time to negative virus load) were not in the registry.
The study was judged to raise some concerns for 4 out of 5 domains which substantially lowered the confidence in the result, hence it was deemed an overall high risk of bias.