Trial NCT04680949; EudraCT 2020-005828-11
Publication Kyriazopoulou E, Nat Med, 2021 (published paper)
Dates: 2020-12-23 to 2021-03-31
Funding: Mixed (Hellenic Institute for the Study of Sepsis and Swedish Orphan Biovitrum AB (Sobi))
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / Greece, Italy Follow-up duration (days): 28 | |
| Inclusion criteria | adult patients of either gender; for women, unwillingness to remain pregnant during the study period; confirmed infection by SARS-CoV-2 virus by molecular test; findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection; need for hospitalization; plasma suPAR 675 ≥6ng/ml |
| Exclusion criteria | any stage IV malignancy; any do not resuscitate decision; ratio or partial oxygen pressure to fraction of inspired oxygen less than 150; need of non-invasive ventilation (CPAP or BPAP) or mechanical ventilation; any primary immunodeficiency; less than 1,500 neutrophils/mm3; oral or intravenous intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days; any anti-cytokine biological treatment including JAK inhibitors the last one month; severe hepatic failure; end-stage renal failure necessitating hemofiltration or peritoneal hemodialysis; pregnancy or lactation. |
| Interventions | |
| Treatment
Placebo * |
|
| Control
Anakinra ( / ) | |
| Participants | |
| Randomized 606 participants (n1=194 / n2= 412) | |
| Characteristics of participants N=606 Mean age : 61.8 344 males Severity : Mild: n=33 / Moderate: n=118/ Severe: n=440 Critical: n=0 | |
| Primary outcome | |
| In the register Comparison of the distribution of frequencies of each score of a 5-scale patient state evaluated from the 11-point WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment [ Time Frame: 28 days ] | |
| In the report Overall comparison of the distribution of frequencies of the scores from the 11-point WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment at Day 28 | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated 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 |
In addition to the published/pre-print articles, the protocol, statistical analysis plan, prospective study registries, supplementary appendices and contact with authors were used in data extraction and risk of bias assessment. Protocol and statistical analysis plan were not available at the time of data extraction. The study achieved the target sample size specified in the trial registries. There is no change from the trial registration in the population or intervention and control treatments. Some timepoints for outcomes listed in the registry were not reported in the paper (e.g. negative viral conversion on day 7 (reported on day 28, day 7 results gained from contact with authors), serious adverse events on day 60 and 90 (reported on day 28).
This trial was updated on July 28th, 2021 with data gained from contact with authors. This trial was updated on August 25th, 2021 with day 90 data gained from further contact with authors. This trial was updated on October 25th, 2021 with data from the peer-reviewed published report. |