COVID-19: Salvage TOcilizumab as a Rescue Measure

NCT04577534 | Completed Phase 3

• 5 other identifiers: EudraCT 2020-002039-312020-002039-31T124/2020KLnro 36/2020dnro 68/06.00.01/2020
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Keywords

COVID-19; new coronavirus disease; tocilizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Time to clinical improvement

  28 days

• Time to decline of at least 2 categories

  28 days

• Incidence of mechanical and/or non-invasive ventilation

  28 days

• Number of ventilator-free days to day 28

  28 days

• Organ failure free days to day 28

  28 days

Study Arms (2)

Tocilizumab (TCZ)

EXPERIMENTAL

Participants will receive one infusion of iv TCZ (according to weight of patient)

Drug: iv Tocillizumab (TCZ)

standard of care (no TCZ)

NO INTERVENTION

Participants will receive standard of care

Interventions

iv Tocillizumab (TCZ) DRUG

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

Tocilizumab (TCZ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Participating in other drug clinical trials
• Absolute neutrophil count \< 1 x10E9/l
• Platelet count \<50 x10E9/l
• ALAT \>10x ULN

Sponsors & Collaborators

• Jarmo Oksi: lead

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Infectious Diseases

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 8, 2020
• Study Start: August 14, 2020
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

FI (1)