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Completed

NCT Number: NCT04510662

Telmisartan in 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Telmisartan Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Regional de Alta Especialidad de Zumpango

Zumpango, State of Mexico, 55600, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telmisartan

Drug

Patients in this group will receive telmisartan 40 mg daily plus standard care.

Primary outcomes

  1. Death

    Time frame: Within 30 days

    Death is defined as all-cause mortality

  2. Mechanical ventilation

    Time frame: Within 14 days

    Occurrence of mechanical ventilation

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Hospital length of stay

    Time frame: Within 14 days

    Hospital length of stay (days)

Sponsors and collaborators

Lead sponsor

Abraham Edgar Gracia-Ramos

Other Gov

Collaborators

  • National Polytechnic Institute, Mexico

Registry information

Official study title

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

Acronym: STAR-COVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2020
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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