Back to resultsCOVID-19: Salvage TOcilizumab as a Rescue Measure (COVIDSTORM)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
iv Tocillizumab (TCZ)
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19, new coronavirus disease, tocilizumab
Eligibility 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
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tocilizumab (TCZ)
standard of care (no TCZ)
Arm Description
Participants will receive one infusion of iv TCZ (according to weight of patient)
Participants will receive standard of care
Outcomes
Primary Outcome Measures
Clinical status at 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
Time to clinical improvement
defined as a National Early Warning Score 2 (NEWS2) of>/=2 maintained for 24 hours
Time to decline of at least 2 categories
relative on a 7-category ordinalscale of clinical status
Incidence of mechanical and/or non-invasive ventilation
(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.
Number of ventilator-free days to day 28
days not in ventilator
Organ failure free days to day 28
days without organ failure
Incidence of ICU stay
ICU admission day
Duration of ICU stay
days on ICU
Time to clinical failure
time to death, mechanical ventilation, or ICU admission (whichever occurs first)
SAPS II
during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)
CCI
during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)
APACHE II
during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)
SOFA 6
during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)
Mortality rate
during and end of period of 28 days
Time to hospital discharge or "ready for discharge"
as evidenced by normal body temperature and respiratory rate and stable oxygen saturation on ambient air or </=2 l supplemental oxygen
Duration of supplemental oxygen
days on suppl oxygen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04577534
Brief Title
COVID-19: Salvage TOcilizumab as a Rescue Measure
Acronym
COVIDSTORM
Official Title
COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
June 16, 2021 (Actual)
Study Completion Date
June 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jarmo Oksi
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, new coronavirus disease, tocilizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab (TCZ)
Arm Type
Experimental
Arm Description
Participants will receive one infusion of iv TCZ (according to weight of patient)
Arm Title
standard of care (no TCZ)
Arm Type
No Intervention
Arm Description
Participants will receive standard of care
Intervention Type
Drug
Intervention Name(s)
iv Tocillizumab (TCZ)
Intervention Description
Participants are randomized (2:1) to receive TCZ or Standard of Care
Primary Outcome Measure Information:
Title
Clinical status at day 28
Description
(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
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Time to clinical improvement
Description
defined as a National Early Warning Score 2 (NEWS2) of>/=2 maintained for 24 hours
Time Frame
28 days
Title
Time to decline of at least 2 categories
Description
relative on a 7-category ordinalscale of clinical status
Time Frame
28 days
Title
Incidence of mechanical and/or non-invasive ventilation
Description
(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.
Time Frame
28 days
Title
Number of ventilator-free days to day 28
Description
days not in ventilator
Time Frame
28 days
Title
Organ failure free days to day 28
Description
days without organ failure
Time Frame
28 days
Title
Incidence of ICU stay
Description
ICU admission day
Time Frame
28 days
Title
Duration of ICU stay
Description
days on ICU
Time Frame
28 days
Title
Time to clinical failure
Description
time to death, mechanical ventilation, or ICU admission (whichever occurs first)
Time Frame
28 days
Title
SAPS II
Description
during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)
Time Frame
28 days
Title
CCI
Description
during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)
Time Frame
28 days
Title
APACHE II
Description
during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)
Time Frame
28 days
Title
SOFA 6
Description
during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)
Time Frame
28 days
Title
Mortality rate
Description
during and end of period of 28 days
Time Frame
28 days
Title
Time to hospital discharge or "ready for discharge"
Description
as evidenced by normal body temperature and respiratory rate and stable oxygen saturation on ambient air or </=2 l supplemental oxygen
Time Frame
28 days
Title
Duration of supplemental oxygen
Description
days on suppl oxygen
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
plan to investigate if it is possible by law
Learn more about this trial
COVID-19: Salvage TOcilizumab as a Rescue Measure
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