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, maximum 800 mg, a second infusion could be administered 12 hours after first |
|
| Control
Standard care ( / ) Definition of Standard care: All patients received usual care for the disease based on the Iranian protocol for diagnosis and treatment of COVID-19. | |
| Participants | |
| Randomized 40 participants (n1=20 / n2= 20) | |
| Characteristics of participants N=40 Mean age : 61.6 19 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| 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 stated
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| 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. |