Trial *
Publication Hamed D M, J Infect Public Heal (2021) (published paper)
Dates: 2020-06-01 to 2020-06-30
Funding: No specific funding
Conflict of interest: No

Methods
RCT
Location : Single center / Dubai
Follow-up duration (days): 45
Inclusion criteria
  • Aged ≥18 years
  • hospitalized
  • clinically and laboratory confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, as shown by positive results on real-time PCR (RT-PCR) of nasopharyngeal swab samples
  • development lung infiltrates involving >50% of the lung fields, as shown on chest X-rays, within 48 h of admission
  • and O2 saturation <93% at rest on room air.
Exclusion criteria
  • Women of child-bearing age
  • patients with known hypersensitivity to tocilizumab
  • organ transplant recipients
  • other active infections, bowel diverticulitis or perforation, heart failure, decompensated liver cirrhosis, cancer, human immunodeficiency virus (HIV) positive
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal
  • neutrophil counts <500/μl
  • or platelet counts <50.000/μl.
Interventions
Treatment
MP+TCZ
40 mg methylprednisolone intravenously twice a day for 7 days plus 400 mg tocilizumab IV once-off
Control
Methylprednisolone
40 mg IV twice a day for 7 days

Participants
Randomized
participants :
MP+TCZ=26
Methylprednisolone=23
Characteristics of participants
N= 49
Mean age : NR
40 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=49 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
NR
In the report
All-cause mortality, rate of admission to the intensive care unit (ICU), length of ICU stay, days on ventilators, and length of hospital stay
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
Some concerns
General comment Only the pre-print article was used in data extraction and assessment of risk of bias. A trial registry, protocol and statistical analysis plan were not available. The trial was not fully randomized: in the prospective part of the study, patients were randomized to receive either methylprednisolone alone or methylprednisolone and tocilizumab, and these arms were compared with a matched historical usual care arm whose data were from a retrospective medical records. For the purpose of this review and NMA we extracted, assessed and compared only the randomized groups.