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

Jarmo Oksi

Status and phase

Completed

Phase 3

Conditions

Covid19

Treatments

Drug: iv Tocillizumab (TCZ)

Study type

Interventional

Funder types

Other

Identifiers

KLnro 36/2020 (Other Identifier)

2020-002039-31 (EudraCT Number)

T124/2020 (Other Identifier)

dnro 68/06.00.01/2020 (Other Identifier)

EudraCT 2020-002039-31

Details and patient eligibility

About

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

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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