Telmisartan in Respiratory Failure Due to COVID-19 (STAR-COVID)

October 3, 2023 updated by: Abraham Edgar Gracia-Ramos

Effectiveness and Safety of Telmisartan in Acute Respiratory Failure Due to COVID-19

Rationale: The renin-angiotensin-aldosterone system (RAAS) dysregulation may play a central role in the pathophysiology of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection associated acute lung injury (ALI) / acute respiratory distress syndrome (ARDS). In the RAAS, Angiotensin I (Ang I) is converted to angiotensin II (Ang II) by angiotensin converting enzyme (ACE). Ang II mediates vasoconstrictive, pro-inflammatory and pro-oxidative effects through agonism at Ang II type 1 receptor (AT1R). ACE2 converts Ang II to angiotensin 1-7 (Ang1-7), which finally binds to Mas receptor (MasR) and mediates many beneficial actions, including vasodilation and anti-inflammatory, anti-oxidant and antiapoptotic effects. ACE2, a homologue of ACE, is an integral cell membrane protein with a catalytic domain on the extracellular surface exposed to vasoactive peptides. SARS-CoV-2 penetrates the cell through ACE2, and the increase of this receptor (due to the use of ACE inhibitors or angiotensin receptor blockers [ARBs]) may facilitate SARS-CoV-2 infection, which might increase the risk of developing severe and fatal SARS-CoV-2 infection. However, through upregulation of ACE2, ACE inhibitors/ARBs can exert anti-inflammatory and antioxidative effects, which may be beneficial in preventing ALI and ARDS.

Objective: To evaluate the effectiveness and safety of telmisartan in respiratory failure due to COVID-19.

Study design: This is an open label, phase 2 clinical trial. Study population: Adult hospitalized SARS-CoV-2-infected patients (n=60). Intervention: The active-treatment arm will receive telmisartan 40 mg daily and the control arm will receive standard care. Treatment duration will be 14 days or up to hospital discharge <14 days or occurrence of the primary endpoint if <14 days.

Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) Mechanical ventilation or 2) Death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Estado De Mexico
      • Zumpango, Estado De Mexico, Mexico, 55600
        • Hospital Regional de Alta Especialidad de Zumpango

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age greater than or equal to 18 years of age.
  • Admitted to the Hospital Regional de Alta Especialidad de Zumpango.
  • Confirmed SARS-CoV-2 infection with either: positive laboratory test for SARS-CoV-2; or positive CT thorax diagnostic for SARS-CoV-2 infection according to the prevailing criteria.
  • Hypoxic respiratory failure: SpO2 ≤94% on room OR tachypnea (respiratory rate ≥22 breaths/min).

Randomization:

  • Within 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis OR
  • within 24 hours of hospital admission in case of pre-hospital confirmed SARS-CoV-2 infection.
  • In case there is a lack of laboratory tests for SARS-CoV-2 in a potentially eligible patient, a positive laboratory test for SARS-CoV-2 will be no longer required. In that case, the potentially eligible patient needs to meet the prevailing criteria for the diagnosis of SARS-CoV-2 infection, such as typical abnormalities on pulmonary CT in the setting of high clinical suspicion of SARS-CoV-2 infection.

Exclusion Criteria:

  • Admitted to ICU prior to randomization.
  • Currently taking an an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB).
  • Use of other investigational drugs at the time of enrollment
  • Prior reaction or intolerance to an ARB; or severe intolerance to an ACEi, defined as angio-oedema requiring medical intervention.
  • Systolic blood pressure < 105 mmHg or diastolic blood pressure <65mmHg.
  • Potassium greater than 5.5 mEq/L within 4 weeks of study enrollment.
  • Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 within 4 weeks of study initiation.
  • A known history of renal artery stenosis.
  • AST and/or ALT > 3 times the upper limit of normal within 4 weeks of study enrollment.
  • Severe liver dysfunction (Child-Pugh score C), biliary cirrhosis or cholestasis.
  • Severe volume depletion or severe acute kidney injury.
  • Inability to obtain informed consent.
  • Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan
Patients in this group will receive telmisartan 40 mg daily plus standard care.
Drug: Telmisartan
Patients in this group will receive telmisartan 40 mg daily plus standard care.
No Intervention: Control
Patients in this group will receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: Within 30 days
Death is defined as all-cause mortality
Within 30 days
Mechanical ventilation
Time Frame: Within 14 days
Occurrence of mechanical ventilation
Within 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of acute kidney injury
Time Frame: Within 14 days
Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2
Within 14 days
Incidence of hypotension
Time Frame: Within 14 days
Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic
Within 14 days
Incidence of hypotension requiring vasopressors
Time Frame: Within 14 days
Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension
Within 14 days
Incidence of Sepsis
Time Frame: Within 14 days
Outcome reported as the number of participants in each arm who experience sepsis, defined as the presence of at least 2 of the following clinical criteria together (qSOFA score): respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less
Within 14 days
Hospital length of stay
Time Frame: Within 14 days
Hospital length of stay (days)
Within 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abraham Edgar Gracia-Ramos

Collaborators

National Polytechnic Institute, Mexico

Investigators

  • Principal Investigator: Abraham Edgar Gracia-Ramos, MD MSc, Hospital Regional de Alta Especialidad de Zumpango

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

May 25, 2021

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI/HRAEZ2020/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data with other researchers to avoid misuse of patient information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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