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 ( / ) | |
| Participants | |
| Randomized 149 participants (n1=74 / n2= 75) | |
| Characteristics of participants N=149 Mean age : NR 62 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=70 Critical: n=39 | |
| 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 stated
|
| 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. |