COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04324021

Emanuele Nicastri, MD

Emanuele.nicastri@inmi.it

2020-03-27

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: signed informed consent provided by the patient, or by the patient's legally authorized representative(s), as applicable. documented presence of sars-cov-2 infection as per hospital routine. age > 18 to < 85 years at the time of screening. presence of respiratory distress, defined as: pao2/fio2 < 300 mm hg and >200 mm hg or respiratory rate (rr) ≥30 breaths/min or spo2 < 93 percent in air at rest. note: patients given continous positive airway pressure (cpap) ventilator support are eligible for inclusion. presence of hyperinflammation defined as: lymphocyte counts: < 1000 cells/µl, in patients who have not received systemic glucocorticoids for at least 2 days prior to the assessment of the lymphocyte count < 1200 cells/µl, in patients who have received systemic glucocorticoids for at least 2 days prior to the assessment of the lymphocyte count and one of the following three criteria: i. ferritin > 500ng/ml ii. ldh > 300 u/l iii. d-dimers > 1000 ng/ml

patients in mechanical ventilation or with modified early warning score (mews) >4 with evidence of moderate or above ards (berlin definition, namely with pao2/fio2 >100, but <200 mm hg) or severe respiratory insufficiency or evidence of rapid worsening (respiratory distress requiring mechanical ventilation or presence of shock or presence of concomitant organ failure requiring icu admission). note: for the evaluation of patient eligibility, temperature will not be considered in the calculation of the total mews score since presence of fever is a hallmark of sars-cov-s infection impairment of cardiac function defined as poorly controlled heart diseases, such as new york heart association (nyha) class ii (mild) and above, cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention. severe renal dysfunction (estimated glomerular filtration rate ≤ 30 ml/min/1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. uncontrolled hypertension (seated systolic blood pressure >180 mmhg, or diastolic blood pressure >110mmhg) . administration of plasma from convalescent patients who recovered from sars-cov-2 infection. clinical suspicion of latent tuberculosis. history of hypersensitivity or allergy to any component of the study drug. pregnant women. existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. enrollment in another concurrent clinical interventional study, or intake of an investigational drug within three months or 5 half-lives prior to inclusion in this study, if considered interfering with this study objectives as assessed by the investigator. foreseeable inability to cooperate with given instructions or study procedures. clinical suspicion of active mycobacteria, histoplasma capsulatum, herpes zoster, salmonella, and shigella infections. patients with liver dysfunction defined as ast or alt > 5 × uln

3

Swedish Orphan Biovitrum

18

80

Italy;United States

Severe disease at enrollment

6: Severe disease at enrollment

16

Number of Participants With Treatment Success

None

Phase 2/Phase 3

[{"arm_notes": "Justification on no results available here: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001167-93/results", "treatment_id": 83, "treatment_name": "Anakinra", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Justification on no results available here: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001167-93/results", "treatment_id": 457, "treatment_name": "Emapalumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Justification on no results available here: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001167-93/results", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]