The effect of an inhibitor of pulmonary inflammation in patients with Covid-19

Phase 2

Recruiting

• Conditions: B97.2; Coronavirus pneumonia

• Registration Number: RBR-5s2mqg
• Lead Sponsor: Faculdade de Ciências Médicas da Universidade Estadual de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified