COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04577534

Jarmo Oksi, prof

jarmo.oksi@utu.fi

2020-10-08

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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)

- 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

2

Jarmo Oksi

18

100

Finland

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

88

Clinical status at day 28

None

Phase 3

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]