Trial NCT04519385
Publication Rashad A, Scientific Reports (2021) (published paper)
Dates: 2020-03-01 to 2020-06-30
Funding: Not reported/unclear (Open access funding: Qatar National Library)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Egypt
Follow-up duration (days): 14
Inclusion criteria
  • Significant deterioration in respiratory clinical status with respiratory rate > 30 cycle/minute
  • Bilateral Chest computed tomography (CT) infiltration > 30%
  • PaO2/FiO2 ratio < 150 or saturation < 90 on > 6 L/min
  • Two positive laboratory tests of the following: (CRP > 10 g/L, lymphocytes < 600 /mm3, D-dimer > 500 ng/mL , ferritin > 500 ng/mL)
Exclusion criteria
  • Pediatric patients < 18 years old
  • active bacterial or fungal infection
  • patients on chemotherapy
  • patients with interstitial lung disease
  • patients who were not requiring supplemental oxygen
Interventions
Treatment
Tocilizumab
4 mg/kg IV once daily for two days
Control
Dexamethasone
Initial dose: 4 mg/kg IV once daily for 3 days, Maintenance dose: 8 mg once daily for ten days

Participants
Randomized
participants :
Tocilizumab=74
Dexamethasone=75
Characteristics of participants
N= 149
Mean age : NR
62 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=70 Critical: n=39
Number of vaccinated participants: NR
Primary outcome
In the register
Proportion of participants with Overall Survival at 14 days
In the report
Time to failure, defined as death, within 14 days from ICU admission
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 published article, the retrospective study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. Blinding is unclear: the report states that “Patients, investigators, and health-care providers were not masked to study drug assignment”; despite being retrospectively registered, the trial is described as single-blind in the registry, with participants and outcome assessor blinded. Described in the report as taking place “in the ICU of ESNA hospital, the first COVID-19 quarantine hospital in Egypt”; yet randomization described as being “stratified by site”. The secondary outcome included in the registry (Fio2/Pao2, Time Frame: 2 days) is not reported as an outcome, but rather considered as a predictor for survival. The study excluded all deaths within the first 3 days (38% vs. 16% of participants in the two groups) from mortality analyses and was consequently assessed as high risk of bias.