Wang 2020.
Study characteristics | ||
Methods | RCT Blinding: unblinded Date of study: from 13 February 2020 to 13 March 2020 Location: multicentre / China Follow‐up duration (days): 14 | |
Participants |
Population: patients with confirmed COVID‐19 (moderate‐severe) to 6 Randomised: 65 participants (n1 Tocilizumab arm = 33 / n2 control arm = 32) Characteristics of participants
Inclusion criteria
Exclusion criteria
Dropouts and withdrawals: 0/65 (0%); 0 withdrawal due to AEs |
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Interventions |
Intervention: tocilizumab (400 mg infusion). Patients received a 2nd dose only if their condition did not improve or worsened. The number of patients received 2nd dose is not reported.
Control: standard care Definition of standard care: standard care was given according to the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (5th or update version)”. Co‐interventions Steroid use at baseline or any time during the study Tocilizumab: NR Standard care: NR |
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Outcomes |
Primary outcome of the trial:
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Notes |
Funding: public/nonprofit (Department of Science and Technology of Anhui Province and Health Commission of Anhui Province, China National Center for Biotechnology Development)
Conflict of interest: declared. No conflict of interest (quote:9 “We declare no competing interests.” Protocol: NR Statistical plan: NR Data‐sharing stated: Yes, to qualifying researchers who submit a proposal with a valuable research question. Overall comment: 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. |
AE: adverse event; ALT: alanine aminotransferase; AST::aspartate aminotransferase; CKD‐EPI score: Chronic Kidney Disease Epidemiology Collaboration; CT: computed tomographic; DSMB: Data and Safety Monitoring Board; EU: European Union; ICU: intensive care unit; IV: intravenous; IL: interleukin; LDH: lactate dehydrogenase; MDRD score: Modification of Diet in Renal Disease; NIHR: National Institute for Health Research; n1: n in experimental arm; n2: n in control arm; NIV: non‐invasive ventilation; NR: not reported; NYHA: New York Heart Association; RCT: randomised controlled trial; SAE: serious adverse event;SGOT: Serum glutamic oxaloacetic transaminase;SGPT; serum glutamic pyruvic transaminase; WHO: World Health Organization.