RBR-5s2mqg
Recruiting
Phase 2
Evaluation of the efficacy and safety of pharmacological inhibition of bradykinin for the treatment of Covid-19
Faculdade de Ciências Médicas da Universidade Estadual de Campinas0 sitesMay 5, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Faculdade de Ciências Médicas da Universidade Estadual de Campinas
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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