NCT04510623

Brief Summary

The coronavirus (COVID-19) pandemic continues to grow exponentially. Angiotensin II levels are increased in human influenza and are associated with influenza viral load, disease progression and mortality. Preliminary data shows angiotensin II receptor blockers (ARBs) limits lung injury in murine influenza H7N9, as well as viral titre and RNA. ARBs could limit viral titre and organ injury in COVID-19. We will therefore collect clinical chart data and test angiotensin II levels of patients who are admitted to ICU with COVID-19 to determine whether there is a correlation between taking ARBs and clinical outcomes in these patients. Other blood biomarkers and clinical risk factors for COVID-19 have come to light in recent weeks. We include these in our observational analysis to help generate an understanding of COVID-19 presentation and blood biomarker characterization of disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
unknown

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

March 17, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

August 11, 2020

Last Update Submit

August 11, 2020

Conditions

Keywords

ARBsangiotensin II type 1 receptor blockerACEiacute respiratory distress syndromeCOVID-19coronavirusMultisiteCanadaObservationalacute kidney injuryshock

Outcome Measures

Primary Outcomes (1)

  • COVID-19 WHO ordinal scale

    14 days

Secondary Outcomes (4)

  • Organ Dysfunction

    14 days

  • 28-day mortality

    29 days or less (may be discharged from critical care before day 28)

  • Hospital/ICU length of stay

    29 days or less (may be discharged before day 28)

  • ICU admission

    29 days or less (may be discharged from critical care before day 28)

Study Arms (4)

COVID-19 Patients on ARBs

This is an observational cohort study. Those who have COVID-19 in hospital and are on Angiotensin Receptor Blockers will be included in this cohort.

Other: ARBs and/or ACE inhibitors

COVID-19 Patients on ACE inhibitors

This is an observational cohort study. Those who have COVID-19 in hospital and are on Angiotensin-Converting Enzyme inhibitors will be included in this cohort.

Other: ARBs and/or ACE inhibitors

COVID-19 Patients on ARBs or ACE inhibitors

This is an observational cohort study. Those who have COVID-19 in hospital and are on ARBs or ACEi's will be included in this cohort.

Other: ARBs and/or ACE inhibitors

COVID-19 Patients not on ARBs or ACE inhibitors

This is an observational cohort study. Those who have COVID-19 in hospital and are not on ARBs or ACEi's will be included in this cohort.

Other: Usual Care

Interventions

This is an observational study only.

COVID-19 Patients on ACE inhibitorsCOVID-19 Patients on ARBsCOVID-19 Patients on ARBs or ACE inhibitors

This is an observational study only.

COVID-19 Patients not on ARBs or ACE inhibitors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult hospitalized patients with confirmed COVID-19

You may qualify if:

  • Individuals over 18 years of age who have confirmed COVID-19 infection (according to local hospital or provincial laboratories clinically approved laboratory testing for COVID-19).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Calgary - Foothills

Calgary, Alberta, Canada

RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

Surrey Memorial Hospital

Surrey, British Columbia, Canada

NOT YET RECRUITING

St Pauls Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

William Osler Health System

Brampton, Ontario, Canada

RECRUITING

Queens University

Kingston, Ontario, Canada

RECRUITING

Humber River Hospital

North York, Ontario, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

St Michael's Hospital

Toronto, Ontario, Canada

NOT YET RECRUITING

Sunnybrook Hospital

Toronto, Ontario, Canada

NOT YET RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, Canada

RECRUITING

Université de Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Related Publications (2)

  • Lee T, Cheng MP, Vinh DC, Lee TC, Tran KC, Winston BW, Sweet D, Boyd JH, Walley KR, Haljan G, McGeer A, Lamontagne F, Fowler R, Maslove D, Singer J, Patrick DM, Marshall JC, Burns KD, Murthy S, Mann PK, Hernandez G, Donohoe K, Rocheleau G, Russell JA; ARBs CORONA I study investigators. Organ dysfunction and death in patients admitted to hospital with COVID-19 in pandemic waves 1 to 3 in British Columbia, Ontario and Quebec, Canada: a cohort study. CMAJ Open. 2022 Apr 19;10(2):E379-E389. doi: 10.9778/cmajo.20210216. Print 2022 Apr-Jun.

  • Russell JA, Marshall JC, Slutsky A, Murthy S, Sweet D, Lee T, Singer J, Patrick DM, Du B, Peng Z, Cheng M, Burns KD, Harhay MO. Study protocol for a multicentre, prospective cohort study of the association of angiotensin II type 1 receptor blockers on outcomes of coronavirus infection. BMJ Open. 2020 Dec 7;10(12):e040768. doi: 10.1136/bmjopen-2020-040768.

MeSH Terms

Conditions

COVID-19Respiratory Distress SyndromeCoronavirus InfectionsAcute Kidney InjuryShock

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James A Russell, MD

    St Paul's Hospital, Center for Heart and Lung Innovation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study-Wide Principal Investigator

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 12, 2020

Study Start

March 17, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2022

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations