COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001275-32/DK

The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark - Sponsor/Investigator

lars.erik.kristensen@regionh.dk

2020-03-24

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

- SARS-CoV-2 infection confirmed by real time-PCR - Positive imaging: consolidation, ground glass opacities, or bilateral pulmonary infiltration either by CT-scan or chest x-ray, - Need of oxygen therapy to maintain SO2>94% OR FiO2/PaO2 < 22 - and at least two of the following laboratory parameters: * CRP level >70 mg/L or CRP level >= 40 mg/L and doubled within 48 hours (without other confirmed infectious or non-infectious course), * Lactatdehydrogenase > 250 U/L, * thrombocytopenia < 120 x 10E9/L, * lymphocyte count < 0.6 x 10E9/L, * D-dimer > 1 ug/mL, * serum ferritin > 300 ug/mL

Age <18 years, pregnancy suspected or confirmed, severe heart failure, suspected or confirmed bacterial infection, current solid or haematological malignancy, neutropenia, ALAT elevation more than three times the laboratory upper limit, ASA class 5 (after COVID19 admission) or higher at inclusion (prior admission), severe chronic obstructive pulmonary disease or heart failure (NYHA class II or higher), current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents including IL-6 inhibitors, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period, current use of chronic oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, previous or active tuberculosis (TB), HIV infection regardless of immunological status, hepatitis, evidence of recent (30 days) invasive bacterial or fungal infections, patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin or plans to receive during the study period, IV drug abuse, history of inflammatory bowel disease, diverticulitis, ulcer, perforated gastrointestinal tract, participation in any clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than five half-lives of IP prior inclusion to the study, any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study, inability to give informed consent.

4

The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark

18

None

Denmark

Severe disease at enrollment

6: Severe disease at enrollment

200

Time to independence from supplementary oxygen therapy in days

Declared number of arm (4.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1148, "treatment_name": "Sarilumab", "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"}]