COVID-19 trials registries data warehouse

https://trialregister.nl/trial/8504

Margriet Dijkstra

m.j.dijkstra-tiekstra@umcg.nl

2020-04-03

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Treatment

? Patients 18 years and older? Patients with a diagnosis of COVID-19 based on a compatible clinical presentation AND a positive SARS-CoV-2 PCR on a respiratory sample such as a nasopharyngeal swab, sputum, or BAL fluid? Clinical features compatible with hyperinflammation:- Hypoxia, without other explanation for hypoxia than COVID-19 OR- ferritin >2000 µg/L or doubling of serum ferritin in 20-48 hoursHypoxia is defined according to ASTCT CRS Consensus grading: grade II. [Lee DW, et al. BBMT 2019,25(4):625-638] Inclusion of patients already requiring oxygen administration prior to COVID-19 should be discussed with the study team.? Written informed consent.? Patient is capable of giving informed consent.

? Pregnancy? allergy to tocilizumab

2

UMCG; Roche

18

None

Netherlands

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

354

30-day mortality (from randomization)

Not reported

[{"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"}]