Trial NCT04577534
Publication COVIDSTORM - Broman N, Clin Microbiol Infect (2022) (published paper)
Dates: 2020-08-12 to 2021-06-16
Funding: No specific funding (No external funding was received for this study or article.)
Conflict of interest: Yes

Methods
RCT
Blinding: Unblinded
Location : Single center / Finland
Follow-up duration (days): 90
Inclusion criteria
  • written informed consaent obtained
  • hospitalized with COVID-19 disease
  • Age >/= 18 years
  • SARS CoV-2 NhO posit
  • Sp=2 30 /min
  • Any 2 of the 4: P-IL-6 > 2 x ULN / P-ferritin > 2 x ULN / P-FIDD >1.5 mg/l / P- CRP >40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 <5.9 ng/l
  • P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l
  • P-FIDD (Fibrin degradation products, D-dimer) <0.5 mg/l
  • P-CRP <10 mg/l)
Exclusion criteria
  • Known severe allergic reactions to monoclonal antibodies
  • Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)
  • In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  • Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)
  • Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O)
  • Participating in other drug clinical trials
  • Absolute neutrophil count < 1 x10E9/l
  • Platelet count <50 x10E9/l
  • ALAT >10x ULN
Interventions
Treatment
Tocilizumab
400 mg for <60 kg, 600 mg for 60 to 90 kg, and 800 mg for >90 kg IV single dose
Control
Standard care

Participants
Randomized
participants :
Standard care=29
Tocilizumab=59
Characteristics of participants
N= 88
Mean age : NR
48 males
Severity : Mild: n=0 / Moderate: n=59 / Severe: n=20 Critical: n=1
Number of vaccinated participants: 0
Primary outcome
In the register
Clinical status at day 28 [ Time Frame: day 28 ](assessed using 7-category ordinal scale) 7 death 6 in ICU with ECMO/ mechanical ventilation 5 in ICU, no ECMO/ mechanical ventilation 4 in hospital, not ICU, needs supplementary oxygen 3 in hospital, not ICU, no supplementary oxygen 2 not in hospital, but not back to normal 1 not in hospital, back to normal
In the report
The primary endpoint was clinical status at day 28 assessed using a seven-category ordinal scale, where 1 is at home, normal daily activities; 2 is at home, assistance needed; 3 is hospitalized, no supplemental oxygen; 4 is hospitalized (non-ICU), receiving supplemental oxygen; 5 is in ICU, no invasive mechanical ventilation (IMV); 6 is in ICU receiving IMV and/or extracorporeal membrane oxygenation; and 7 is dead.
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
Some concerns
General comment Data presented was originally 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.
On April 14, 2022, the extraction and risk of bias assessments were updated with information from the published article. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Of note: the outcomes Mortality (D60 or more) and Time to death were not reported in the 2022 publication and thus are the original extractions from 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. Furthermore, we extracted data reported as severe adverse events in the published report under our serious adverse events outcome.