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COVID-19: Salvage TOcilizumab as a Rescue Measure (COVIDSTORM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577534
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Jarmo Oksi, Turku University Hospital

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

Condition or disease Intervention/treatment Phase
Covid19 Drug: iv Tocillizumab (TCZ) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: Tocilizumab (TCZ)
Participants will receive one infusion of iv TCZ (according to weight of patient)
Drug: iv Tocillizumab (TCZ)
Participants are randomized (2:1) to receive TCZ or Standard of Care

No Intervention: standard of care (no TCZ)
Participants will receive standard of care



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577534


Contacts
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Contact: Jarmo Oksi, prof +358 40 5414813 jarmo.oksi@utu.fi

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Sponsors and Collaborators
Jarmo Oksi
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Responsible Party: Jarmo Oksi, Head of Infectious Diseases, Turku University Hospital
ClinicalTrials.gov Identifier: NCT04577534    
Other Study ID Numbers: EudraCT 2020-002039-31
2020-002039-31 ( EudraCT Number )
T124/2020 ( Other Identifier: Turku University Hospital )
KLnro 36/2020 ( Other Identifier: Fimea )
dnro 68/06.00.01/2020 ( Other Identifier: TUKIJA / VALVIRA )
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: plan to investigate if it is possible by law

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jarmo Oksi, Turku University Hospital:
COVID-19
new coronavirus disease
tocilizumab