COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001770-30/BE

CHU AMBROISE PARE - dr Camelia Rossi

camelia.rossi@hap.be

2020-04-15

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

- Positive COVID status as defined by: PCR documented SARS-CoV-2 carriage in nasopharyngeal sample or evocative thoracic scan images of COVID-19 associated with typical clinical presentation - Hospitalized patients aged ≥ 18 and ≤ 75 years old - Signs of severe COVID-19 pneumonia (3 of the followings) - Patient wheezing or unable to speak in full sentences while at rest/with minimal effort - Respiratory rate >22 - PaO2 <65 mmHg or SpO2 <90% - Repeated chest imaging is significantly worsening despite being on standard of care, which may include anti-viral treatment, low dose steroids and antibiotics.

- Immunosuppresion - End stage renal failure and dialysis - Life expectancy < 1 year (due to a condition other than COVID) - Active neoplasia (treated or not) - Breastfeeding and pregnant patients - Known severe allergic reactions to TCZ or other monoclonal antibodies - Non treated HIV infection, chronic B hepatitis, active C hepatitis, active tuberculosis infection - Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 6 months - Participating in other drug clinical trials

2

CHU AMBROISE PARE

18

75

Belgium

Severe disease at enrollment

6: Severe disease at enrollment

60

Clinical status assessed using a 7-category ordinal scale at Day 28

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"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"}]