Covid-19 Living Data

Trial NCT04412772
Publication ARCHITECTS - ARCHITECTS, Unpublished (2021) (unpublished results)
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 single dose, may be repeated once
	Control Placebo
Participants
	Randomized participants : Tocilizumab=10 Placebo=11
	Characteristics of participants N= 21 Mean age : NR 12 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=1 Critical: n=20 Number of vaccinated participants: NR
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 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	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.