Trial ChiCTR2000029765
Publication Wang D, Front Med (2021) (published paper)
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

Methods
RCT
Blinding: Unblinded
Location : Multicenter / China
Follow-up duration (days): 14
Inclusion criteria
  • Eligible patients diagnosed with COVID-19 through reverse transcriptase polymerase chain reaction positivity for SARS-CoV-2
    1) 18-85 years old

  • 2) plasma IL-6 levels elevated

  • 3) moderate (with bilateral pulmonary lesions) or severe in disease degree.

    The diagnosis of moderate or severe disease was defined according to the “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (5th or updated version)” sponsored by the National Health Commission of the People’s Republic of China as follows:
    Moderate disease, fever or other respiratory symptoms, bilateral pulmonary lesions confirmed by chest imaging

  • Severe disease was defined if any of the following conditions was met:
    (1) respiratory rate ≥ 30 breaths per min

  • (2) SpO2 ≤ 93% while breathing room air

  • (3) PaO2/FiO2 ≤ 300 mmHg.
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
Interventions
Treatment
Tocilizumab
400 mg (diluted in 100 ml 0.9% saline) IV infusion for more than 1 hour.
A second dose is given if the patient remains febrile for 24 hours after the first dose.

Control
Standard care

Participants
Randomized
participants :
Tocilizumab=33
Standard care=32
Characteristics of participants
N= 65
Mean age : NR
33 males
Severity : Mild: n=0 / Moderate: n=37 / Severe: n=28 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Cure rate
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
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

Not reported
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
Some concerns
General 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 updated on March 11th, 2021 with data from the published report.