COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-5s2mqg

Lício Velloso

lavelloso@fcm.unicamp.br

2020-05-05

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Patients aged 18 years at the time of signing Consent Form, 12 days since onset of the symptoms until the start of treatment, SARS-CoV-2 diagnosis by RT-PCR method, pneumonia confirmed by computed tomography of the chest, hospitalized patients with a SpO2 < 94% in ambient air or Pa02/FiO2 < 300 mmHg, the patient or responsible family member (incapacitated patients) must have signed the consent form, the patient must agree not to enrol in any other experimental study prior to completing the 28-day follow-up.

Women in pregnancy or breastfeeding (pregnancy-beta-HCG-test will be performed in women of childbearing age), known severe renal impairment (estimated glomerular filtration rate < 30 ml/min/1.73 m2), or patients receiving continuous renal replacement therapy (hemodialysis or peritoneal dialysis), or previous renal transplant, known severe liver disease (AST or ALT 5X above the reference value), patients diagnosed with HIV infection or patient with any other immunodeficiencies, patients with the previous diagnosis of cancer, patients with the previous diagnosis of hereditary angioedema, patients with previous ischemic myocardial disease, patients with previous thromboembolic disease, if the assisting physician considers that the participation of the patient in the study is not appropriate, either because it is not of clinical interest or because of any condition that does not allow the protocol to be followed safely, the patient will be transferred to any other hospital before the 28 days of follow-up or before a disclosure (discharge from hospital), receipt of any experimental treatment for COVID-19 virus infection within 30 days prior to molecular screening.

3

Faculdade de Ciências Médicas da Universidade Estadual de Campinas

18

100

Brazil

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

0

Time to clinical improvement (TTCI); which refers to the time from randomization to an improvement of two points on the seven-category ordinal scale stated below or live discharge from the hospital: 1. not hospitalized with a resumption of normal activities; 2. not hospitalized; but unable to resume normal activities; 3. hospitalized; not requiring supplemental oxygen; 4. hospitalized; requiring supplemental oxygen; 5. hospitalized; requiring nasal high-flow oxygen therapy or non-invasive mechanical ventilation; 6. hospitalized; requiring ECMO; invasive mechanical ventilation; or both; and 7. death.The time for clinical improvement or even hospital discharge will be measured in days.

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 601, "treatment_name": "Human plasma-derived c1 esterase inhibitor", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 621, "treatment_name": "Icatibant", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]