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OpenTrials
Completed

NCT Number: NCT04577534

COVID-19: Salvage TOcilizumab as a Rescue Measure

Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Turku University Hospital

Turku, 20521, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written informed consaent obtained
  • hospitalized with COVID-19 disease
  • Age >/= 18 years
  • SARS CoV-2 NhO posit
  • Sp=2 </93% on ambient air or respiratory rate >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

Treatment and study plan

iv Tocillizumab (TCZ)

Drug

Participants are randomized (2:1) to receive TCZ or Standard of Care

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to clinical improvement

    Time frame: 28 days

    defined as a National Early Warning Score 2 (NEWS2) of>/=2 maintained for 24 hours

  2. Time to decline of at least 2 categories

    Time frame: 28 days

    relative on a 7-category ordinalscale of clinical status

  3. Incidence of mechanical and/or non-invasive ventilation

    Time frame: 28 days

    (mode and duration of respiratory support) Hospital day when respiratory support needed with non-invasive ventilation - and duration.

    Hospital day when respiratory support needed by invasive mechanical ventilation -and duration.

  4. Number of ventilator-free days to day 28

    Time frame: 28 days

    days not in ventilator

  5. Organ failure free days to day 28

    Time frame: 28 days

    days without organ failure

  6. Incidence of ICU stay

    Time frame: 28 days

    ICU admission day

  7. Duration of ICU stay

    Time frame: 28 days

    days on ICU

  8. Time to clinical failure

    Time frame: 28 days

    time to death, mechanical ventilation, or ICU admission (whichever occurs first)

  9. SAPS II

    Time frame: 28 days

    during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)

  10. CCI

    Time frame: 28 days

    during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)

  11. APACHE II

    Time frame: 28 days

    during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)

  12. SOFA 6

    Time frame: 28 days

    during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)

  13. Mortality rate

    Time frame: 28 days

    during and end of period of 28 days

  14. Time to hospital discharge or "ready for discharge"

    Time frame: 28 days

    as evidenced by normal body temperature and respiratory rate and stable oxygen saturation on ambient air or </=2 l supplemental oxygen

  15. Duration of supplemental oxygen

    Time frame: 28 days

    days on suppl oxygen

Sponsors and collaborators

Lead sponsor

Jarmo Oksi

Other Gov

Registry information

Official study title

COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease

Acronym: COVIDSTORM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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