COVID-19: Salvage TOcilizumab as a Rescue Measure

Covid19 Clinical Trial

— COVIDSTORM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577534
• Other study ID #: EudraCT 2020-002039-31
• Secondary ID: 2020-002039-31T1
• Status: Completed
• Phase: Phase 3
• Start date: August 14, 2020
• Est. completion date: June 16, 2021

Study information

• Verified date: June 2021
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• iv Tocillizumab (TCZ)
Participants are randomized (2:1) to receive TCZ or Standard of Care

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Jarmo Oksi

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 28
Secondary	Time to clinical improvement	defined as a National Early Warning Score 2 (NEWS2) of>/=2 maintained for 24 hours	28 days
Secondary	Time to decline of at least 2 categories	relative on a 7-category ordinalscale of clinical status	28 days
Secondary	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.	28 days
Secondary	Number of ventilator-free days to day 28	days not in ventilator	28 days
Secondary	Organ failure free days to day 28	days without organ failure	28 days
Secondary	Incidence of ICU stay	ICU admission day	28 days
Secondary	Duration of ICU stay	days on ICU	28 days
Secondary	Time to clinical failure	time to death, mechanical ventilation, or ICU admission (whichever occurs first)	28 days
Secondary	SAPS II	during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)	28 days
Secondary	CCI	during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)	28 days
Secondary	APACHE II	during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)	28 days
Secondary	SOFA 6	during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)	28 days
Secondary	Mortality rate	during and end of period of 28 days	28 days
Secondary	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	28 days
Secondary	Duration of supplemental oxygen	days on suppl oxygen	28 days