NCT04633772

Brief Summary

The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that could be altered in COVID-19 patient and its supplementation may potentially helpful in this setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

November 6, 2020

Last Update Submit

November 8, 2021

Conditions

Infection, CoronavirusRespiratory Failure

Keywords

angiotensin-(1-7)ARDSrenin angiotensin system

Outcome Measures

Primary Outcomes (1)

  • supplemental oxygen-free days (SOFDs)

    28 - x, where x = number of days on which the patient is released from supplemental oxygen therapy after start

    28 days

Secondary Outcomes (13)

  • Hospital length of stay

    through study completion, on average 60 days

  • ventilator free days

    28 days

  • ICU free days

    through study completion, on average 40 days

  • RAS effectors levels

    Baseline, 3 and 24 hours after randomization and 72 hours after randomization

  • CT scan findings

    through study completion, on average 30 days

  • +8 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Angiotensin-(1-7)

EXPERIMENTAL
Drug: Angiotensin-(1-7)

Interventions

Angiotensin-(1-7)DRUG

Intravenous supplementation of Angiotensin-(1-7)

Angiotensin-(1-7)
PlaceboDRUG

NaCl 0.9%

Placebo

Eligibility Criteria

Age17 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to the Intensive Care Unit with severe pneumonia criteria (clinical signs of pneumonia + one of the following criteria: respiratory rate greater than 30/minute; signs of respiratory effort, SatO2 \< 90% in room air);
  • COVID-19 confirmed or highly suspicious (positive contact or suggestive image)

You may not qualify if:

  • Diagnosed with cancer (at any stage);
  • Hemodynamic instability (need for vasopressors);
  • Pregnant women; Immunocompromised patients;
  • Palliative Care;
  • Heart failure as a predominant cause of acute respiratory failure;
  • Decompensated liver cirrhosis;
  • HIV +;
  • Dialysis;
  • Home / long-term oxygen therapy;
  • Idiopathic pulmonary fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Eduardo de Menezes

Belo Horizonte, Minas Gerais, 30190-081, Brazil

Location

Hospital Mater Dei

Belo Horizonte, Minas Gerais, 31270-910, Brazil

Location

Related Publications (1)

  • Martins ALV, Annoni F, da Silva FA, Bolais-Ramos L, de Oliveira GC, Ribeiro RC, Diniz MML, Silva TGF, Pinheiro BD, Rodrigues NA, Dos Santos Matos AH, Motta-Santos D, Campagnole-Santos MJ, Verano-Braga T, Taccone FS, Santos RAS. Angiotensin-(1-7) infusion in COVID-19 patients admitted to the ICU: a seamless phase 1-2 randomized clinical trial. Ann Intensive Care. 2024 Sep 4;14(1):139. doi: 10.1186/s13613-024-01369-0.

    PMID: 39231898DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsRespiratory Insufficiency

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Robson AS Santos

    Angitex

    PRINCIPAL INVESTIGATOR

  • Ana Martins Valle

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

  • Filippo Annoni

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 18, 2020

Study Start

August 5, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)