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Efficacy and Safety of Angiotensin II Use in Coronavirus Disease(COVID)-19 Patients With Acute Respiratory Distress Syndrome (ACES)

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ClinicalTrials.gov Identifier: NCT04408326
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 5, 2020
Sponsor:
Collaborators:
Australian and New Zealand Intensive Care Research Centre
Monash University
Royal Surrey County Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

This study aims to find out whether the use of angiotensin II, which is a drug to raise blood pressure has been approved by European Medical Agency in August 2019, as an add-on medication to increase blood pressure in patients with COVID-19, acute severe lung injury, inflammation and severe shock, compared with standard medication. In addition, the investigators will collect the data of Anakinra, another drug which is frequently used in this condition to reduce inflammation.

The investigators will collect clinical data and outcomes from critical care patients. The investigators will analyse for whom these drugs are most beneficial and explore whether there are any patients who don't benefit or have side effects.


Condition or disease Intervention/treatment
COVID Acute Respiratory Distress Syndrome Drug: Angiotensin II Drug: Interleukin-1 receptor antagonist

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Angiotensin II Use in COVID-19 Patients With Acute Respiratory Distress Syndrome
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021


Group/Cohort Intervention/treatment
Angiotensin II
Patients with COVID-19 and acute respiratory distress syndrome who received angiotensin II as an add-on vasopressor will be collected
Drug: Angiotensin II
Exogenous angiotensin II acts on angiotensin II type 1 receptor and raise blood pressure by vasoconstriction, salt and water retention, and stimulation of aldosterone hormone

Anakinra
Patients with COVID-19 and acute respiratory distress syndrome who received Anakinra (interleukin 1 receptor antagonist) will be collected
Drug: Interleukin-1 receptor antagonist
Interleukin-1 receptor antagonist is an immunomodulating drug aiming to mitigate cytokine storm in COVID-19 patients
Other Name: Anakinra

Angiotensin II control
Patients with COVID-19 and acute respiratory distress syndrome who also received vasopressor support will be matched to angiotensin II group by date of intensive care unit admission, age, history of hypertension, history of angiotensin converting enzyme inhibitor/angiotensin receptor blocker, respiratory support
Anakinra control
Patients with COVID-19 and acute respiratory distress syndrome will be matched to Anakinra group by matching age and date of intensive unit care admission



Primary Outcome Measures :
  1. Proportions of patients with mean arterial pressure ≥ 65 mmHg or an increase of mean arterial pressure ≥10 mmHg at 3 hours [ Time Frame: 3 hours ]
    Percentage


Secondary Outcome Measures :
  1. Noradrenaline dose [ Time Frame: 1 hour and 3 hours ]
    microgram/kg/min

  2. Sequential Organ Failure Assessment (SOFA) score [ Time Frame: baseline, 24, and 48 hours ]
    Changes in score, minimum 0, maximum 24, the higher score showing worse prognosis

  3. RRT-free days [ Time Frame: 28 days ]
    Patients who are alive and do not require renal replacement therapy at 28 days

  4. RRT discontinuation [ Time Frame: 7 and 28 days ]
    Proportions of patients who do not require renal replacement therapy

  5. Serum creatinine [ Time Frame: 7 days and 28 days ]
    micromol/L

  6. PaO2/FiO2 ratio [ Time Frame: baseline, 24, and 48 hours ]
    Changes in value

  7. Mortality [ Time Frame: 7 days and 28 days ]
    Mortality rate

  8. Adverse events [ Time Frame: 28 days ]
    e.g. arrhythmia, thromboembolism, etc.

  9. Change in serum C-reactive protein [ Time Frame: 7 days ]
    Change in serum C-reactive protein

  10. Change in serum ferritin [ Time Frame: 7 days ]
    Change in serum ferritin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with confirmed COVID-19 infection and acute respiratory distress syndrome
Criteria

Inclusion Criteria:

  1. Adult patients (≥ 18 years old) admitted to intensive care units overseen by critical care consultants
  2. Confirmed COVID-19 infection
  3. ARDS defined as per the BERLIN ARDS definition1
  4. For angiotensin data only: Vasodilatory shock as diagnosed clinically by the treating physicians and receiving noradrenaline for less than 12 hours from the onset of shock or arrival to hospital

Exclusion Criteria:

  1. Pure cardiogenic shock
  2. Stage 4 cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408326


Contacts
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Contact: Marlies Ostermann, MD, PhD 0044 207 188 3038 Marlies.Ostermann@gstt.nhs.uk
Contact: Nuttha Lumlertgul, MD, PhD 0044 207 188 3038 Nuttha.Lumlertgul@gstt.nhs.uk

Locations
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United Kingdom
Guy's & St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Marlies Ostermann, MD, PhD    020 71883038    Marlies.Ostermann@gstt.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Australian and New Zealand Intensive Care Research Centre
Monash University
Royal Surrey County Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Marlies Ostermann Department of Critical Care, Guy's & St Thomas' Hospital
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04408326    
Other Study ID Numbers: 283005
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Interleukin 1 Receptor Antagonist Protein
Angiotensin II
Giapreza
Angiotensinogen
Antirheumatic Agents
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action