COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04357860

Julián de la Torre Cisneros

Antonio Luque, uicec@imibic.org (PI email not reported)

2020-04-22

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - age ≥ 18 years and <75 years - admission for confirmed respiratory symptoms to covid-19 based on a positive pcr in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring onaf or mechanical ventilation - interstitial pneumonia confirmed by chest radiography or ct - il-6 levels> 40 pg / ml. in its absence, d-dimer (dd)> 1500 or> 1000 may be included if progressive increases are documented - negative pregnancy test in women of childbearing age - signature of informed consent

- sofa score> 6 points - patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation - neutrophil count <2 x 103 / μl - platelet count <100 x 103 / μl - alt or ast levels> 5 times the upper limit of normal - severe renal failure (crcr <30 ml / min) - active bacterial infectious process - active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis - history of intestinal ulcer or diverticulitis - history of hypersensitivity reactions to sarilumab or its excipients - treatment with tnf antagonists - previous treatment with anti-il6 in the previous 30 days - chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. yes, inhaled and topical corticosteroids are acceptable - concomitant treatment with immunomodulators, among which are vitamin d or statins. macrolides such as azithromycin are acceptable - patients on immunosuppressive treatment for any cause - hiv-infected patients with cd4 <200 / mm3 - past or current history of autoimmune disease or systemic inflammatory disease - patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins - participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product - pregnancy - any other condition that, in clinical judgment, prevents adherence to the patient's protocol

3

Maimónides Biomedical Research Institute of Córdoba

18

75

Spain

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

120

Ventilation requirements

None

Phase 2

[{"arm_notes": "", "treatment_id": 1148, "treatment_name": "Sarilumab", "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"}]