Trial IRCT20081027001411N4
Publication Talaschian M, Research Square (2021) (preprint)
Dates: 2020-07-10 to 2020-10-10
Funding: Public/non profit (Tehran University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Iran
Follow-up duration (days): 28
Inclusion criteria
  • Confirmed COVID-19 infection (RT-PCR)
  • Elevated C-reactive protein (CRP higher than 10mg/L) or IL-6 (higher than 18 pg/ml) or lymphopenia (lymphocyte count under 1100/ MCL)
  • At the pulmonary stage of the disease with blood oxygen saturation <93% or respiratory rate (RR) higher than 24
  • Not connecting to the mechanical ventilator
  • Not responding to standard COVID-19 treatment
  • informed consent before enrollment.
Exclusion criteria
  • Allergic or intolerant to any therapeutic factors used in this study
  • With positive pro-calcitonin (PCT) and had an active infection (including latent or active tuberculosis (TB) infection)
  • Had a history of receiving immunosuppressive drugs and corticosteroids
  • With a history of active malignancies.
Interventions
Treatment
Tocilizumab
8 mg/kg IV infusion single dose, maximum 800 mg, a second infusion could be administered 12 hours after first
Control
Standard care

Participants
Randomized
participants :
Tocilizumab=20
Standard care=20
Characteristics of participants
N= 40
Mean age : NR
19 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Radiographic features Findings Before treatment and 6 weeks after treatment: Mortality rate Before and after treatment; Need an oxygen therapy Before and after (at day 5 after treatment and discharge time); O2 saturation Before and after (at day 5 after treatment and at discharge time)
In the report
Improvement and discharge or death after administration of intervention whichever came first
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
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 pre-print article, the study registry was used in data extraction and risk of bias assessment. The protocol or statistical analysis plan were not available. The study achieved the target sample size specified in the trial registry. The trial registry was updated after study completion to reflect changes made in inclusion and exclusion criteria and control intervention (changed from placebo to standard care only). The registry stated the trial to be quadruple blinded however, no placebo was used during the study.
Quote: "In this study, patients, investigators, and outcome assessors did not inform which group received an intervention. Besides, a placebo was not used in the control group." Hence it is unclear if participants and personnel/carers were blinded
The registry primary outcome does not reflect the reported primary outcome. Some outcomes reported in the pre-print paper and used in the NMA are are not pre-specified in the registry (clinical improvement and SAEs). The study was assessed to be at a high risk of bias because of some concerns in four domains.