COVID-19: Salvage TOcilizumab as a Rescue Measure

• Status: Completed
• Trial end date: 2021-06-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jarmo Oksi

Criteria

Inclusion Criteria:

• written informed consaent obtained

• hospitalized with COVID-19 disease

• Age >/= 18 years

• SARS CoV-2 NhO posit

• Sp=230 /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