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

NCT04408326 | Unknown FDA Drug

• 1 other identifier: 283005
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportions of patients with mean arterial pressure ≥ 65 mmHg or an increase of mean arterial pressure ≥10 mmHg at 3 hours

  Percentage

  3 hours

Secondary Outcomes (10)

• Noradrenaline dose

  1 hour and 3 hours

• Sequential Organ Failure Assessment (SOFA) score

  baseline, 24, and 48 hours

• RRT-free days

  28 days

• RRT discontinuation

  7 and 28 days

• Serum creatinine

  7 days and 28 days

Study Arms (4)

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

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

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

Interventions

Angiotensin II DRUG

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

Angiotensin II

Interleukin-1 receptor antagonist DRUG

Interleukin-1 receptor antagonist is an immunomodulating drug aiming to mitigate cytokine storm in COVID-19 patients

Also known as: Anakinra

Anakinra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with confirmed COVID-19 infection and acute respiratory distress syndrome

You may qualify if:

• Adult patients (≥ 18 years old) admitted to intensive care units overseen by critical care consultants
• Confirmed COVID-19 infection
• ARDS defined as per the BERLIN ARDS definition1
• 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

You may not qualify if:

• Pure cardiogenic shock
• Stage 4 cancer

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Australian and New Zealand Intensive Care Research Centre: collaborator
• Monash University: collaborator
• Royal Surrey County Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Guy's & St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Angiotensin II; Receptors, Interleukin-6; Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors; Receptors, Interleukin; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Cytokines; Intercellular Signaling Peptides and Proteins

Study Officials

• Marlies Ostermann

  Department of Critical Care, Guy's & St Thomas' Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlies Ostermann, MD, PhD

CONTACT

0044 207 188 3038; Marlies.Ostermann@gstt.nhs.uk

Nuttha Lumlertgul, MD, PhD

CONTACT

0044 207 188 3038; Nuttha.Lumlertgul@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: June 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 4, 2021

Record last verified: 2021-08

Locations

GB (1)