Trial NCT04412772
Publication ARCHITECTS, Unpublished, 2021 ( )
Dates: 2020-06-12 to 2020-08-28
Funding: Public/non profit (Queen's Medical Centre)
Conflict of interest: *
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / USA Follow-up duration (days): 90 | |
| Inclusion criteria | Hospitalized with COVID-19 pneumonia, based on chest X-ray or CT scan; Evidence of hyperinflammation: IL-6>40pg/mL OR ferritin >2000 ng/mL AND iv. One or more of the following: impending need for requiring invasive or non-invasive mechanical ventilation OR shock requiring vasopressor (without evidence of bacterial / fungal infection) OR need for extracorporeal membrane oxygenation (ECMO) OR severe, refractor ARDS (PaO2/FiO2<200 mmHg) |
| Exclusion criteria | Known severe allergic reactions to tocilizumab or other monoclonal antibodies; Active tuberculosis infection based on history; Suspected active bacterial, fungal, viral, or other infection (besides COVID-19); In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments; Have received oral anti-rejection or immunomodulatory drugs (including tocilizumab) with the past 6 months; Participating in other drug clinical trials (participation in COVID-19 trials allowed); Self-reported pregnant or breastfeeding; Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at baseline; Absolute neutrophil count (ANC) < 1000/mL at baseline; Platelet count < 50,000/mL at baseline |
| Interventions | |
| Treatment
Tocilizumab 8mg/kg (max 800 mg) IV once-off, may be repeated once |
|
| Control
Placebo | |
| Participants | |
| Randomized 21 participants (n1=10 / n2= 11) | |
| Characteristics of participants N=21 Mean age : NR 12 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=1 Critical: n=20 | |
| Primary outcome | |
| In the register Clinical status (on a 7-point ordinal scale) at day 28 [ Time Frame: up to day 28 ] Clinical Status 7-point ordinal scale:Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death | |
| In the report NR | |
| 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 |
Low |
| General comment | The study is not published yet. Data presented was extracted from study registry and The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group "Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis." JAMA. 2021;326(6):499–518. The authors have been contacted in order to obtain the results. |