Trial NCT04399980, NCT04463004, NCT04492514
Publication MASH-COVID - Cremer P, Lancet Rheumatol (2021) (published paper)
Dates: 2020-05-28 to 2020-09-15
Funding: Private (Kiniksa Pharmaceuticals)
Conflict of interest: Yes
Methods | |
RCT Blinding: double blinding | |
Location :
Multicenter / USA Follow-up duration (days): 60 | |
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Treatment
Mavrilimumab 6 mg/kg IV infusion once-off |
|
Control
Placebo | |
Participants | |
Randomized participants : Placebo=19 Mavrilimumab=21 | |
Characteristics of participants N= 40 Mean age : NR 26 males Severity : Mild: n=0 / Moderate: n=20 / Severe: n=20 Critical: n=0 Number of vaccinated participants: NR | |
Primary outcome | |
In the register Proportion of subjects alive and off of oxygen at day 14 [ Time Frame: Day 14 ] | |
In the report Proportion of patients alive and off supplemental oxygen therapy at day 14 after infusion of mavrilimumab or placebo | |
Documents available |
Protocol Yes. In English Statistical plan Yes 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 |
Some concerns |
General comment | In addition to the published article, the trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. There were no substantive differences between the published article and the protocol in population, procedures, interventions or outcomes. Exploratory outcomes included in the protocol were not included in the registry. Some exploratory outcomes that required laboratory testing were not fully measured due to pandemic demands on laboratory resources, and were therefore not reported. The study did not achieve its pre-stated sample size. Due to slow enrollment, the study was stopped early to inform the natural history and potential treatment effect. |