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

Randomized clinical trial phase I/II for the use of angiotensin-(1-7) in the treatment of severe infection by Sara-CoV-2

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-35734p

Enrollment

Unknown

Registered

2020-08-05

Start date

2020-08-05

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Infection with Sara-CoV-2

Interventions

initially, 30 patients with severe Covid-19 grade will be treated with intravenous administration of angiotensin- (1-7) for up to 7 days to assess the safety of this treatment (Phase I). If this step

Biological/vaccine

Other

D06.472.699.094

Eligibility

Age

17 Years to 81 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Brazil

Contacts

Public ContactAna Luiza;Robson Valle;Santos

Universidade Federal de Minas Gerais;Angitec

anavalle9@icloud.com;santos@icb.ufmg.br+55(31)97654162;+55(31)987762956

Outcome results

None listed

Source: REBEC (via WHO ICTRP)