Treatment of severe COVID-19 with angiotensin-(1-7)

Phase 1

Recruiting

• Conditions: Severe Infection with Sara-CoV-2; C01.925.782.600.550.200

• Registration Number: RBR-35734p
• Lead Sponsor: Angitec

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Age: less than 17 and less or equal to 81 years; Admission to the Intensive Care Unit with severe pneumonia criteria (clinical signs of pneumonia + one of the following criteria: respiratory rate greater than 30 irpm; signs of respiratory effort, SatO2 less than 90% in room air); COVID-19 confirmed or highly suspicious (positive contact or suggestive image)

Exclusion Criteria

Patients diagnosed with cancer (at any stage); Hemodynamic instability (need for vasopressors); Pregnant women; Immunocompromised patients; Exclusive Palliative Care; Inclusion in any other interventionist study; Heart failure as a predominant cause of acute respiratory failure; decompensated liver cirrhosis; HIV +; Dialysis; Home / long-term oxygen therapy; Idiopathic pulmonary fibrosis

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: the primary outcome of the study will be the supplemental oxygen-free days (SOFDs) at 28 days., defined as SOFDs = 28 - x, where x = number of days on which the patient is released from supplemental oxygen therapy after start.

Secondary Outcome Measures

Name	Time	Method
We expect a reduction of the time necessary for the recovery and/or in the length of hospital stay. ;We expect a reduction in mechanical ventilation (number of days free from mechanical ventilation - invasive or not) ;A increase of the days free from ICU is expected., ;WE expect a general improvement of the clinical/laboratorial state ( reduction of secondary infections, of the need of vasopressors, or incidence of deep vein thrombosis, and improvement of the changes in inflammatory and thrombotics markers (CRP, D-dimer, Troponin, chemokine). ;Evaluation of possible changes in circulating Ang II and Ang-(1-7) using Mass spectrometry;We expect a reduction of the changes in radiological findings (computed tomography and chest radiography ) as well as the incidence of findings compatible with late pulmonary fibrosis.