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
Methylprednisolone 40 mg IV twice a day for 7 days |
|
Control
Methylprednisolone +Tocilizumab ( / ) | |
Participants | |
Randomized 49 participants (n1=23 / n2= 26) | |
Characteristics of participants N=49 Mean age : 48.5 40 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=49 Critical: n=0 | |
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 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 |
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. |