Trial NCT04399980, NCT04463004, NCT04492514
Publication 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: | |
| Location :
Multicenter / USA Follow-up duration (days): 60 | |
| Inclusion criteria | Inpatient hospitalisation for COVID-19; documented COVID-19 pneumonia defined as a positive upper respiratory tract specimen for SARS-CoV-2 with associated abnormalities or infiltrates on chest x-ray or chest CT; active fever or documented fever within 48 h or antipyretic use; hypoxaemia, defined as a room air oxygen saturation of less than 92% or requirement of supplemental oxygen; and a C-reactive protein concentration greater than 5 mg/dL. |
| Exclusion criteria | Age younger than 18 years ; absolute neutrophil count less than 1500/mm3 ; home oxygen therapy ; mechanical ventilation ; uncontrolled systemic bacterial infection ; and onset of symptoms more than 14 days before hospital admission and enrolment. |
| Interventions | |
| Treatment
Mavrilimumab 6 mg/kg IV infusion once-off |
|
| Control
Placebo | |
| Participants | |
| Randomized 40 participants (n1=21 / n2= 19) | |
| Characteristics of participants N=40 Mean age : NR 26 males Severity : Mild: n=0 / Moderate: n=20/ Severe: n=20 Critical: n=0 | |
| 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 stated No |
| 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. |