Trial *
Publication Pupim L, Ann. Rheum. Dis (2021) (published paper)
Funding: Not reported/unclear
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / USA, Brazil, Chile, Peru, and South Africa Follow-up duration (days): 28 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Mavrilimumab 6 or 10 mg/kg intravenously once-off |
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Control
Placebo | |
Participants | |
Randomized NR Analyzed 114 participants Mavrilimumab=75 Placebo=39 | |
Characteristics of participants N= 114 Mean age : NR 0 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register NR | |
In the report Proportion of patients alive and free of mechanical ventilation at Day 29 | |
Documents available |
Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported |
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 |
* |
General comment | The conference abstract was available for data extraction and risk of bias assessment. The trial is described as ongoing in the abstract. No registry, protocol or statistical analysis plan was available. The trial included patients with severe COVID-19 requiring supplemental oxygen and mechanical ventilation; only those not requiring mechanical ventilation are included in this report. Unclear whether the study achieved its sample size and unclear number of patients randomized and analyzed. No outcomes were extracted. |