Trial Trial NL8504
Publication Rutgers A, PLoS ONE (2022) (published paper)
Dates: 2020-04-06 to 2021-01-12
Funding: Mixed (Participating hospitals; Roche (drug supplier))
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / The Netherlands
Follow-up duration (days): 30
Inclusion criteria
  • 18 years or older
  • Capable of providing informed consent
  • SARS-CoV-2 infection confirmed by nasopharyngeal swab polymerase chain reaction
  • Admitted to a ward
  • Have at least one of the following signs compatible with hyperinflammation: 1) a need for supplemental oxygen (inspired by the ASTCT consensus grade 2 for CRS, generally matching a saturation < 94%) and/or 2) ferritin >2000ug/l or a doubling of serum ferritin in 20-48 hrs
Exclusion criteria
  • Pregnancy
  • Allergy to tocilizumab
Interventions
Treatment
Tocilizumab
8 mg/kg IV infusion single dose, maximum 800 mg. A second infusion could be administered 8 after the first
Control
Standard care

Participants
Randomized
participants :
Tocilizumab=174
Standard care=180
Characteristics of participants
N= 354
Mean age : NR
237 males
Severity : Mild: n=0 / Moderate: n=257 / Severe: n=82 Critical: n=3
Number of vaccinated participants: NR
Primary outcome
In the register
30-day mortality (from randomization)
In the report
30-day mortality after randomization, assessed as a time-to-event endpoint
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
Low
General comment In addition to the pre-print article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The study achieved it target sample size.There is no change from the trial registration in the intervention and control treatments. The registry primary outcome does reflect the reported primary outcome. Some outcomes in the registry (normalization of HRCT, seroconversion 14 days after randomization) were not reported in the pre-print paper. Some outcomes are reported in the paper, but were not pre-specified in the trial registry (for example time to WHO score 7 and above). Considered an interim analysis since only 30-day outcomes are reported. A 3-month endpoint is included in the registry, which reports study status as recruitment terminated and trial finished. This study was updated on October 5, 2022 with information from the published report.